Young age at menarche tied to elevated risk of diabetes in mid-life: BMJ

USA: A recent study published in BMJ Nutrition Prevention & Health reveals an association between earlier age at menarche and type 2 diabetes among young and middle-aged women and with stroke complications among these women with diabetes.

“Starting menstrual cycles at a young age before the age of 13 is linked to a heightened risk of developing type 2 diabetes in mid-life,” the US study stated. 

It also seems to be associated with an increased risk of having a stroke before the age of 65 in those with the disease, particularly those who started having periods before the age of 10 or younger, the findings indicate.

Diabetes and its complications are on the rise among young and middle-aged US adults, while the age at which women start having periods is falling worldwide, note the researchers.

They therefore wanted to find out if there might be a link between these two phenomena in younger women, and drew on responses to the nationally representative National Health and Nutrition Examination Survey (NHANES) 1999–2018.

Some 17,377 women aged between 20 and 65 were included in the study, all of whom specified the age at which they had had their first menstrual cycle. This was categorised as 10 or younger, 11, 12, 13, 14 and 15 and older.

Of the total, 1773 (10%) reported a diagnosis of type 2 diabetes. And of these, 205 (11.5%) reported some type of cardiovascular disease.

Starting periods before the average age of 13 was associated with a heightened risk of type 2 diabetes, after accounting for a range of potentially influential factors, including age, race/ethnicity, education, motherhood, menopausal status and family history of diabetes, smoking, physical activity, alcohol consumption and weight (BMI).

This ranged from 32% greater (10 or younger) through 14% greater (age 11) to 29% greater (age 12).

Among women with diabetes, earlier age at first menstrual cycle was associated with a heightened risk of stroke, although not cardiovascular disease in general, after accounting for the same set of potentially influential factors.

Very early age at first menstrual cycle-10 or younger-was associated with a more than doubling in stroke risk among women below the age of 65 with diabetes, after similar adjustments for influential factors.

This risk fell in tandem with increasing age: 81% among those with their first menstrual bleed at the age of 11, to 32% at the age of 12, and to 15% at the age of 14.

This is an observational study, and as such, can’t establish causal factors. But, suggest the researchers: “Earlier age at [first menstrual cycle] may be one of early life indicators of the cardiometabolic disease trajectory in women.”

They explain: “One potential pathway explanation may be that [such] women are exposed to oestrogen for longer periods of time, and early [menstruation] has been associated with higher oestrogen levels.”

They point out that while the observed associations between age at first menstrual cycle and stroke complications weakened slightly after accounting for weight, these still remained statistically significant.

“Therefore, adiposity may also play a role in the observed association between early age at [first menstrual cycle] and stroke complications, as higher childhood adiposity is associated with earlier age at [menstruation] and with cardiometabolic diseases later in life,” they suggest.

“These findings add another dimension to the potentially less well understood determinants of cardiometabolic risk, particularly in women who have been relatively underrepresented in this area of research,” comments Professor Sumantra Ray, Executive Director of the NNEdPro Global Centre for Nutrition & Health, which co-owns BMJ Nutrition Prevention & Health.

“And they provide a clear steer on the need to design interventional studies looking at the prevention of cardiometabolic disease in ethnically diverse groups of women who start menstruating at a young age,” he adds.

Reference:

Santos MP, Li Y, Bazzano LA, et alAge at menarche, type 2 diabetes and cardiovascular disease complications in US women aged under 65 years: NHANES 1999–2018BMJ Nutrition, Prevention & Health 2023;e000632. doi: 10.1136/bmjnph-2023-000632.

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Novel X-ray shield cuts radiation exposure to the operator by greater than 80 per cent: Study

Norway: Radiation shielding is necessary during cardiac catheterization, but there is a need to improve ease of use and efficacy. A recent study published in Circulation: Cardiovascular Interventions sought to evaluate the shielding effect and user feedback for a novel flexible multiconfiguration x-ray shield (FMX).

The researchers found that the reusable and flexible radiation shield that lays across the patient like a blanket can reduce tradition to operators in that cath lab by as much as 84% compared with routine protection strategies.

“The reductions in radiation dose to the operators were similar for diagnostic angiography and PCI and similar in female and male operators,” reported Cedric Davidsen, Haukeland University Hospital, Bergen, Norway, and colleagues. According to them, the novel device they developed and tested offered protection against scatter that may be missed by table- and ceiling-mounted shields.

“The FMX was designed to maintain ease of use and protection across a variety of patients, procedure types, and access sites,” the study stated. “The system can be fully and immediately removed or repositioned in seconds according to clinical need.”

The 0.5-mm Pb equivalent FMX can be configured selectively to accommodate for variations in access site, patient morphology, and type of procedure with maintained visualization, shielding, and vascular access. Relative operator dose (operator dose indexed for given dose) was measured during 103 consecutive procedures randomized in the proportion of 1:1 to the current routine setup or FMX+routine, to evaluate the efficacy. User feedback was collected on relevance, function, and likelihood of adoption into clinical practice.

The study revealed the following findings:

  • The median relative operator dose was 3.63 μSv/µGy·m2×10-3 with routine setup and 0.57 μSv/µGy·m2×10-3 with FMX+routine, which amounts to an 84.4% reduction.
  • For 500 procedures/year, this corresponds to an estimated yearly dose reduction from 3.6 to 0.7 mSv.
  • User feedback regarding size, ease of use, functionality, likelihood to use, critical issues, draping, shielding, vascular access, procedure time, patient discomfort, and risk was 99% positive.
  • No critical issues were identified. There was no significant difference in patient radiation exposure.

“The FMX considerably reduced radiation exposure and represents an attractive and effective solution for radiation protection that can easily be implemented in existing workflow,” the researchers wrote.

“FMX has the potential for general use with maintained visualization, shielding, and vascular access in routine cardiac catheterization,” they concluded.

Reference:

Davidsen C, Ytre-Hauge K, Samnøy AT, Vikenes K, Lancellotti P, Tuseth V. Efficacy and User Experience of a Novel X-Ray Shield on Operator Radiation Exposure During Cardiac Catheterization: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2023 Nov 13:e013199. doi: 10.1161/CIRCINTERVENTIONS.123.013199. Epub ahead of print. PMID: 37955163.

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Omega-3 Fatty Acids fail to provide protection against retinopathy among diabetes patients

Omega-3 Fatty Acids fail to provide protection against retinopathy among diabetes patients suggests a new study published in the Ophthalmology.

Results from a substudy of the ASCEND trial suggest that the use of omega-3 fatty acids had no clinically meaningful benefit compared to placebo for the development of diabetic retinopathy.

“Preclinical studies demonstrate a protective role for omega-3 fatty acids in diabetic retinopathy, but these observations have not been confirmed in randomized trials,” the researchers write.

The safety and effectiveness of omega-3 fatty acids on health has been under the microscope of cardiometabolic health study participants for a decade. Although much of the attention has been devoted to the REDUCE-IT and STRENGTH studies, which examined icosapent ethyl (Vascepa) and an EPA/DHA agent, respectively, several other studies have been initiated to further explore the associations between different forms of omega to study -3 fatty acids, like the ASCEND study.

In a double-blind, randomized, placebo-controlled trial of adult patients aged 40 years and older with diabetes but no apparent cardiovascular disease, the A Study of Cardiovascular Events in Diabetes (ASCEND), 15,480 patients were randomized to a 1st course -gram capsule containing 460 mg eicosapentaenoic acid and 380 mg docosahexaenoic acid or equivalent placebo with olive oil daily. The study’s primary outcome of interest was first major vascular event and median follow-up duration of 7.4 years.

The results of the study indicate that a major vascular event occurred in 8.9% of the omega-3 fatty acid group and 9.2% of the placebo group (rate ratio). [RR], 0.97; 95% confidence interval [CI]0.87 to 1.08; P=.55). Further analysis showed that all-cause deaths occurred in 9.7% of the omega-3 fatty acid group and 10.2% of the placebo group (RR: 0.95; 95% CI: 0.86 to 1, 05).

In a substudy of the ASCEND trial called ASCEND-EYE, a team of researchers led by Jane Armitage, FRCP, FFPH, from the Nuffield Department of Public Health, used linked data from the records of the NHS Diabetic Eye Screening Program in England and Wales to To identify participants from the study who developed diabetic retinopathy. The investigators noted that ocular events reported were assessed through medical record review.

The primary efficacy outcome of interest for the subsidy was time to first record of a communicable disease after randomization, which researchers defined as a combination of communicable retinopathy or communicable maculopathy based on evaluation criteria established by the UK National Screening Committee . The sub-study also included several secondary and tertiary outcomes, such as: B. Transferable disease outcomes stratified by baseline DR severity, any progression of retinopathy grade, and incident diabetic maculopathy.

A total of 7360 participants with linkage data were included in the current study, representing 48% of those randomized in ASCEND. At baseline, this cohort had a mean age of 63.5 (standard deviation: 8.9) years, 62% of the group were male, 96% were white, and 95% had type 2 diabetes. The median follow-up duration in this cohort was 6.5 years.1.4

In the analysis, 14.8% of the omega-3 fatty acid group and 13.9% of the placebo group experienced a transmissible disease event (RR: 1.07; 95% CI: 0.95-1.20 ; P=.29). Further analysis revealed that there were no statistically significant differences between groups in

the proportion of events for the secondary or tertiary endpoints.

Reference:

Sammons EL, Buck G, Bowman LJ, et al. ASCEND-Eye: Effects of Omega-3 Fatty Acids on Diabetic Retinopathy. Ophthalmology. Published online December 3, 2023. doi:10.1016/j.ophtha.2023.11.030

Keywords:

Omega-3, Fatty, Acids, fail, provide, protection, against, retinopathy, among, diabetes, patients, Sammons EL, Buck G, Bowman LJ, Ophthalmology

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Smartwatches to detect abnormal heart rhythms in kids

Smart watch is a fashion in recent times, it keeps you notified on your daily routine and your fitness schedule. Smart watches can help physicians detect and diagnose irregular heart rhythms in children, according to a new study from the Stanford School of Medicine.

The finding comes from a survey of electronic medical records for pediatric cardiology patients receiving care at Stanford Medicine Children’s Health. The study published online Dec. 13 in Communications Medicine.

Over a four-year period, patients’ medical records mentioned “Apple Watch” 145 times. Among patients whose medical records mentioned the smartwatch, 41 had abnormal heart rhythms confirmed by traditional diagnostic methods; of these, 29 children had their arrythmias diagnosed for the first time.

The Stanford Medicine research team plans to conduct a study to further assess the utility of the Apple Watch for detecting children’s heart problems. The study will measure whether, in kids, heart rate and heart rhythm measurements from the watches match measurements from standard diagnostic devices.

The study is open only to children who are already cardiology patients at Stanford Medicine Children’s Health. Apple’s Irregular Rhythm Notification and ECG app are cleared by the Food and Drug Administration for use by people 22 years of age or older. The high heart rate notification is available only to users 13 years of age or older

 “I was surprised by how often our standard monitoring didn’t pick up arrythmias and the watch did,” said senior study author Scott Ceresnak, MD, professor of pediatrics. Ceresnak is a pediatric cardiologist who treats patients at Stanford Medicine. “It’s awesome to see that newer technology can really make a difference in how we’re able to care for patients.”

The study’s lead author is Aydin Zahedivash, MD, a clinical instructor in pediatrics.

Most of the abnormal rhythms detected were not life-threatening, Ceresnak said. However, he added that the arrythmias detected can cause distressing symptoms such as a racing heartbeat, dizziness and fainting. Skipping a beat, sometimes doctors face two challenges in diagnosing children’s cardiac arrythmias, or heart rhythm abnormalities.

The first is that cardiac diagnostic devices, though they have improved in recent years, still aren’t ideal for kids. Ten to 20 years ago, a child had to wear, for 24 to 48 hours, a Holter monitor consisting of a device about the size of a smartphone attached by wires to five electrodes that were adhered to the child’s chest. Patients can now wear event monitors-in the form of a single sticker placed on the chest-for a few weeks. Although the event monitors are more comfortable and can be worn longer than a Holter monitor, they sometimes fall off early or cause problems such as skin irritation from adhesives.

The second challenge is that even a few weeks of continuous monitoring may not capture the heart’s erratic behavior, as children experience arrythmias unpredictably. Kids may go months between episodes, making it tricky for their doctors to determine what’s going on.

From 145 mentions of the smartwatch in patient records, 41 patients had arrythmias confirmed. Of these, 18 patients had collected an ECG with their watches, and 23 patients had received a notification from the watch about a high heart rate.

The information from the smartwatches prompted the children’s physicians to conduct medical workups, from which 29 children received new arrythmia diagnoses. In 10 patients, the smartwatch diagnosed arrythmias that traditional monitoring methods never picked up.

 “The wearable market is exploding, and our kids are going to use them,” Ceresnak said. “We want to make sure the data we get from these devices is reliable and accurate for children. Down the road, we’d love to help develop pediatric-specific algorithms for monitoring heart rhythm.”

“These irregular heartbeats are not life-threatening, but they make kids feel terrible,” Ceresnak said. “They can be a problem and they’re scary, and if wearable devices can help us get to the bottom of what this arrythmia is, that’s super helpful.”

Reference: Smartwatches can pick up abnormal heart rhythms in kids, Stanford Medicine study finds; STANFORD MEDICINE, Communications Medicine

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Extra-low dose levothyroxine improves pregnancy outcomes in women with subclinical hypothyroidism undergoing IVF

Extra-low dose levothyroxine improves pregnancy outcomes in women with subclinical hypothyroidism undergoing IVF suggests a new study published in the Taiwanese Journal of Obstetrics and Gynecology

This study was undertaken to test the therapeutic effect of extra-low dose of levothyroxine (LT4; 25 mcg/day) to preconception and pregnant women with subclinical hypothyroidism (SCH).

This is a retrospective study, SCH women who succeeded in their first in vitro fertilization (IVF) cycle between January 1, 2018, to December 31, 2020 were included. SCH is defined as normal serum free thyroxine (T4) level and an elevated serum thyroid stimulating hormone (TSH) level >4 mIU/L. Extra-low dose of levothyroxine (LT4; 25 mcg/day) was prescribed to the SCH women from the establish of diagnosis of SCH to the end of pregnancy. The pregnancy outcomes (miscarriage, live birth, preterm birth, and small for gestational age baby) were compared to the euthyroid pregnant women.

Results:

Totally, 589 women were screened, and 317 cases received their first time IVF treatment. 167 women were clinically pregnant after IVF treatment, 155 of them were euthyroid and 12 of these women were diagnosed to have SCH. The average age of the participants was 35 years old. There were no significant differences in age, body mass index (BMI), anti-müllerian hormone (AMH), types of embryo transfer, number of embryos to transfer, or embryo stage during transfer between two groups. The live birth rate, miscarriage rate, and preterm birth rate in women with SCH supplemented with extra-low dose of LT4 were non-inferior to euthyroid patients (miscarriage rate: P = 0.7112; live birth rate: P = 0.7028; preterm delivery: P = 0.2419; small for gestational age: P = 0.2419).

The result demonstrated that supplementation with extra-low dose of levothyroxine at 25 mcg/day to SCH women can produce the comparable obstetrical and neonatal outcome as that in euthyroid pregnant women. Accordingly, we suggest extra-low-dose of levothyroxine may be considered as a safe and effective alternative for those SCH pregnant women who were not tolerated to the standard dose of levothyroxine.

Reference:

Chen YT, Ho CH, Chung MT, Wen JY, Lin YL, Hsiao TW, Tsai YC. Effect of extra-low dose levothyroxine supplementation on pregnancy outcomes in women with subclinical hypothyroidism undergoing in vitro fertilization and embryo transfer. Taiwan J Obstet Gynecol. 2023 Nov;62(6):869-873. doi: 10.1016/j.tjog.2023.05.014. PMID: 38008507.

Keywords:

Extra-low, dose, levothyroxine, improves, ancy, outcomes, women, subclinical, hypothyroidism, undergoing, IVF, Chen YT, Ho CH, Chung MT, Wen JY, Lin YL, Hsiao TW, Tsai YC, Infertility; In vitro fertilization and embryo transfer; Levothyroxine; Pregnancy outcome; Subclinical hypothyroidism.

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Fetuin A significantly decreased in patients with calcific aortic valve disease

Pakistan: A recent meta-analysis published in Atherosclerosis Plus has shown a significant reduction in fetuin-A in patients with known calcific aortic valve disease (CAVD).

The research, however, revealed no association between fetuin-A and calcific aortic valve disease in kidney disease patients. The investigator Muhammad Omar Larik from Dow International Medical College in Karachi, Pakistan, suggest the need for further research to arrive at a robust conclusion regarding fetuin-A use as a diagnostic biomarker for calcific aortic valve disease.

Calcific aortic valve disease is a common valvular disease that is particularly prevalent within the older age groups. The potential use of biomarkers in diagnosing and assessing CAVD severity in supplementation with imaging techniques has recently gained momentum within the field of cardiovascular medicine. Therefore, Dr. Omar Larik performed a meta-analysis to assess the association between the fetuin-A levels and the presence of CAVD.

For this purpose, online databases were searched from inception to April 2023. The Newcastle-Ottawa scale was utilized for bias assessment to determine the quality of the included studies. The initial search revealed fourteen potentially relevant studies. Nine studies (including 3,280 patients with CAVD and 7,505 patients as controls) were selected after a comprehensive full-text screening.

The researchers reported the following findings:

  • A total of 3,280 patients with CAVD and 7,505 patients as control were included in the analysis, resulting in the pooling of 10,785 patients in this meta-analysis.
  • It was observed that the circulating levels of fetuin-A were significantly lowered in patients with CAVD (SMD: -0.20).
  • The analysis revealed that fetuin-A levels had no significant association with CAVD in patients suffering from kidney disease (SMD: 0.20).

“While initial results showed the potential effectiveness,” the study stated, “there is a need for further research is essential to arrive at a robust conclusion regarding fetuin-A use as a diagnostic biomarker for calcific aortic valve disease.”

Limitations include the unadjusted data that may account for some inconsistencies, as populations of certain studies were subject to a variation of comorbidities when compared to other studies, such as the presence of diabetes mellitus, hypertension, or smoking history. Also, the mata-analysis was performed exclusively using observation studies accounting for an increased level of heterogeneity.

Reference:

Larik, M. O. (2023). Fetuin-A levels in association with calcific aortic valve disease: A meta-analysis. Atherosclerosis Plus, 54, 27-29. https://doi.org/10.1016/j.athplu.2023.09.004

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Bariatric Surgery Associated with Lower Pregnancy Weight Gain: JAMA

A recent study has uncovered the significant insights into the association between bariatric surgery and pregnancy outcomes. Researchers have found in a new study that Bariatric Surgery is Associated with Lower Pregnancy Weight Gain among women.

The findings of the study were published in Journal of American Medical Association.

The research conducted in Sweden from 2014 to 2021 involved 12,776 pregnancies. This study aimed to compare pregnancy weight gain among women with a history of bariatric surgery and those without, looking into potential variations based on surgical procedures and time intervals.

The findings reveal that women with a history of bariatric surgery experienced lower pregnancy weight gain across all early-pregnancy BMI strata when compared to their matched counterparts. The differences in pregnancy weight gain were notable, with a decrease observed in normal weight, overweight, and obese classes I, II, and III.

The findings indicates that pregnancy weight gain did not significantly differ based on the specific bariatric surgical procedure. A shorter surgery-to-conception interval, particularly within one year, or lower surgery-to-conception weight loss was correlated with reduced pregnancy weight gain. This highlights the nuanced factors influencing maternal health post-bariatric surgery.

The study emphasized the importance of these findings understanding that state the impact of bariatric surgery on pregnancy outcomes is crucial for healthcare providers and expectant mothers. The study contributes valuable information to guide personalized maternal care for women with a history of bariatric surgery.

This extensive study helps in understanding the complex relationship between bariatric surgery and pregnancy but also underscores the significance of tailoring healthcare interventions based on individual patient characteristics. More studies like these will play a vital role in enhancing the understanding and improving outcomes for mothers and their offspring.

Source:

Xu, H., Holowko, N., Näslund, I., Ottosson, J., Arkema, E. V., Neovius, M., Stephansson, O., & Johansson, K. (2023). Pregnancy Weight Gain After Gastric Bypass or Sleeve Gastrectomy. In JAMA Network Open (Vol. 6, Issue 12, p. e2346228). American Medical Association (AMA). https://doi.org/10.1001/jamanetworkopen.2023.46228

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Adolescent obesity major risk factor for early chronic kidney disease in young adulthood: JAMA

Israel: Obese adolescents may be at higher risk for developing early chronic kidney disease in young adulthood, a recent study published in JAMA Pediatrics has suggested.

The cohort study of 593 660 adolescents revealed that high body mass index (BMI) in late adolescence was associated with early chronic kidney disease (CKD), and there was an increase in risk with increasing severity of obesity. The risk was also seen in seemingly healthy individuals with high-normal BMI and before 30 years of age.

There has been a rise in obesity rates in adolescents, despite this, data regarding early kidney sequelae are lacking. To fill this knowledge gap, Avishai M. Tsur, Israel Defense Forces, Medical Corps, Tel Hashomer, Ramat Gan, Israel, and colleagues aimed to assess the association between adolescent BMI and early chronic kidney disease in young adulthood (<45 years of age). Early CKD was defined as stage 1 to 2 CKD by moderately or severely increased albuminuria with an estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 m2 or higher.

The researchers linked screening data of mandatory medical assessments of Israeli adolescents to data from a CKD registry of a national health care system. It included adolescents aged 16 to 20 years; born since January 1, 1975; medically evaluated for mandatory military service and insured by Maccabi Healthcare Services. Those with dysglycemia, hypertension, albuminuria, kidney pathology, or missing BMI or blood pressure data were excluded.

BMI was calculated as weight (in kilograms) divided by height (in meters squared) and categorized by sex- and age-matched percentiles according to the US Centers for Disease Control and Prevention (CDC). Follow-up initiated at the time of medical evaluation or January 1, 2000 (whichever came last), and ended at the early onset of CKD, death, the last day insured or August 23, 2020 (whichever came first).

The study led to the following findings:

  • Of 629 168 adolescents evaluated, 593 660 (mean age at study entry, 17.2 years; 54.5% males) were included in the analysis.
  • During a mean follow-up of 13.4 years for males and 13.4 years for females, 0.3% developed early CKD.
  • Among males, the adjusted hazard ratios were 1.8 for adolescents with high-normal BMI, 4.0 for those with overweight, 6.7 for those with mild obesity, and 9.4 for those with severe obesity.
  • Among females, the hazard ratios were 1.4 for those with high-normal BMI, 2.3 for those with overweight, 2.7 for those with mild obesity, and 4.3 for those with severe obesity.
  • The results were similar when the cohort was limited to individuals who were seemingly healthy as adolescents, individuals surveyed up to 30 years of age, or those free of diabetes and hypertension at the end of the follow-up.

“These findings underscore the importance of reducing adolescent obesity rates and managing risk factors for kidney disease in adolescents with high body mass index,” the researchers concluded.

Reference:

Tsur AM, Akavian I, Landau R, et al. Adolescent Body Mass Index and Early Chronic Kidney Disease in Young Adulthood. JAMA Pediatr. Published online December 11, 2023. doi:10.1001/jamapediatrics.2023.5420

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Daily prune consumption lowers effects of bone loss among postmenopausal women: Study

USA: Bone loss is a significant issue impacting more than 50% of women over the age of 50, and there is no cure. A new study published in The Journal of Nutrition has shown the beneficial effects of dietary supplementation with 50–100 g prunes for reducing bone loss. 

The researchers reported that the daily consumption of prunes may reduce inflammation markers connected to bone signalling pathways and reduce the effects of bone loss among postmenopausal women.

“Bone loss is a significant issue impacting more than 50% of women over the age of 50, and there is no cure,” said Principal Investigator Mary Jane De Souza, PhD, Professor, Department of Kinesiology, Pennsylvania State University. “While medications and hormone therapies are available, they often require lifelong management and come with risks. It’s important to have a better understanding of how non-pharmacological approaches lifestyle and dietary choices-can also impact the progression and mitigation of bone loss.”

The new study’s findings show significant reductions in inflammatory cytokines, which are proteins that help control inflammation, and activated monocytes, which are a major type of immune cell that has been shown to drive the chronic inflammatory response, when 50 to 100 grams of prunes (about 5-12 prunes) are included in the diet, daily. Specifically, reductions were seen in Tumor Necrosis Factor-α following 50 grams of daily prune intake, and reductions in Interleukin-1β, Interleukin-6, Interleukin-8 secretions, as well as activated monocytes, with 100 grams of prune intake, compared to diets without prunes.

“These findings may be attributed to the abundance of bioactive compounds found in prunes, including vitamins, minerals, phenolic acids and polyphenols, which are likely acting synergistically to suppress activated monocytes and their secretion of bone-resorptive inflammatory cytokines,” said Co-author Connie Rogers, PhD, MPH, Professor and Department Head, Department of Nutritional Sciences, University of Georgia.

This is an ancillary study of a larger, single-center, parallel-arm, 12-month randomized control trial[1] (PRUNE study). The PRUNE study aimed to explore immune, inflammatory and oxidative stress markers related to the bone-protective effects of prunes in nonsmoking and not severely obese postmenopausal women, aged 55-75 years who refrained from phenolic supplements or large amounts of phenolic-containing fruit (apples and blueberries) for at least 2 months prior to the start of the study. This investigation was completed by 183 participants who were split into three groups: control/no prunes (n=70), 50 grams/day prunes (n=67) and 100 grams/day prunes (n=46). After a run-in period, participants followed the prune protocol for a total of 12-months and were instructed to record the days and number of prunes eaten in a daily log, used to monitor compliance. Participants were considered compliant if they consumed more than 80% of their prescribed treatment, and all participants consumed more 90% of their prescribed treatment.

Measurements of immune, inflammatory and oxidative stress markers were taken at baseline and at the end of the 12-month intervention. Beyond the prune intake protocols, all participants received a daily dose of calcium and vitamin D3 to meet the recommended dietary allowance of 1200 mg of calcium and 800 IU vitamin D3 daily from diet plus supplements, and they followed a free-living diet.

“These findings add to a growing body of research and interest investigating the role of ‘food as medicine’ and complement other studies I have conducted using the same data,” De Souza said. “For example, the previous study I led showed connections between hip bone integrity and daily consumption of prunes—where postmenopausal women who did not eat prunes lost 1.5% of their hip bone density compared to women who ate 5-6 prunes daily. Collectively, these findings have significant practical importance given the prevalence of bone loss among this population.”

“Our investment in the PRUNE study has led to many key publications and novel findings that can help improve public health and the understanding of the role foods may play in disease prevention and management,” said Donn Zea, executive director, California Prune Board. “We are deeply committed to the scientific rigor of our nutrition research program which provides a license to communicate how enjoying California Prunes can have an effect on health outcomes.”

For about 100 calories, a serving of 4-6 California Prunes is a nutrient-dense superfood providing more than 20 different vitamins, minerals and plant compounds to the diet. As a premium dried fruit enjoyed across cultures and ethnicities, research into California Prunes’ health benefits contributes to a better understanding of their role as a dietary tool to promote health and potentially lower chronic disease risk.

Reference:

Janhavi J. Damani, Ester S. Oh, Mary Jane De Souza, Nicole CA. Strock, Nancy I. Williams, Cindy H. Nakatsu, Hang Lee, Connie Weaver, Connie J. Rogers, Prune Consumption Attenuates Proinflammatory Cytokine Secretion and Alters Monocyte Activation in Postmenopausal Women: Secondary Outcome Analysis of a 12-Mo Randomized Controlled Trial: The Prune Study, The Journal of Nutrition, https://doi.org/10.1016/j.tjnut.2023.11.014.

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Novel hypolipidemic bempedoic acid safe in diabetics, may overcome shortcomings of statins: Lancet

Statins reduce LDL cholesterol and cardiovascular events among those with or without diabetes but have been reported to increase new-onset diabetes. A prespecified analysis of CLEAR outcomes trial published recently in The Lancet journal has shown that unlike statins, bempedoic acid is not associated with an increased risk of new-onset diabetes, even in those in the pre-diabetic stage.

More than a decade ago, the US Food and Drug Administration mandated that statins carry a warning about reports of increased blood sugar and HbA1c levels with treatment.

In the 2008 JUPITER trial, for example, rosuvastatin was associated with a significantly increased risk of new-onset diabetes. That risk was confirmed in Sattar et al’s meta-analysis of 13 randomized trials involving more than 90,000 patients showing that statin use was associated with a small, but statistically significant, 9% higher relative risk of new-onset diabetes compared with placebo.

The CLEAR Outcomes trial demonstrated that bempedoic acid reduced the risk of MACE among statin-intolerant patients at high cardiovascular risk. In the present prespecified analysis, the authors aimed to evaluate the cardiovascular benefits of bempedoic acid, in individuals with diabetes, and to evaluate the risk of new-onset diabetes and HbA1c among those without diabetes in the CLEAR Outcomes trial.

The CLEAR Outcomes is a randomised, double-blind, placebo-controlled trial. Patients with or without cardiovascular disease who were unwilling or unable to take guideline-recommended doses of statins and an LDL cholesterol of 2·59 mmol/L or more were randomly assigned (1:1) in a double-blinded manner to either bempedoic acid 180 mg once per day or placebo.

In this prespecified analysis, the efficacy endpoint was a time-to-event analysis of four-component major adverse cardiovascular event (MACE-4), which is the composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularisation, using the intention-to-treat population stratified by baseline glycaemia status.

The prespecified analysis of risk of new-onset diabetes and HbA1cincrease was evaluated in patients without diabetes at baseline.

The authors found that:

1. Over a median of 3·4 years follow up, patients with diabetes had significant relative and absolute cardiovascular risk reductions in MACE-4 endpoints with bempedoic acid compared to placebo.

2. The proportion of patients who developed new-onset diabetes were similar between the bempedoic acid and placebo groups.

3. HbA1c levels at 12 months and the end of the study were similar between randomised groups in patients who had prediabetes and normoglycaemia.

4. Placebo-corrected LDL cholesterol concentrations and high-sensitivity C-reactive protein at 6 months were reduced in each glycaemic stratum (diabetes, prediabetes, and normoglycaemia) for patients randomly assigned to bempedoic acid.

Importantly, among those without diabetes at baseline, the use of bempedoic acid over 3.4 years of follow-up did not lead to an increase in new-onset diabetes or worsening HbA1c levels, which is a concern with statin therapy. The agent also was linked to a small amount of weight loss.

To conclude, among patients with diabetes, bempedoic acid reduces LDL cholesterol and high-sensitivity C-reactive protein and risk of cardiovascular events. Patients without diabetes had no increase in new-onset diabetes or worsening HbA1c with bempedoic acid. The efficacy and cardiometabolic safety profile of bempedoic acid makes it a clinical option for those with and without diabetes.

SOURCE: The Lancet : https://doi.org/10.1016/S2213-8587(23)00316-9

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