NIH to investigate whether vitamin D helps prevent Type 2 diabetes
BETHESDA, Md. — Researchers have begun the first definitive, large-scale clinical trial to investigate if a vitamin D supplement helps prevent or delay Type 2 diabetes in adults who have prediabetes and are at high risk for developing Type 2. Funded by the National Institutes of Health, the study is taking place at about 20 study sites across the United States, the agency announced Monday.
The multiyear Vitamin D and Type 2 Diabetes study will include about 2,500 people. Its goal is to learn if vitamin D — specifically D3 (cholecalciferol) — will prevent or delay Type 2 diabetes in adults ages 30 years or older with prediabetes. People with prediabetes have blood-glucose levels that are higher than normal but not high enough to be called diabetes.
“This study aims to definitively answer the question: Can vitamin D reduce the risk of developing Type 2 diabetes?” stated Myrlene Staten, D2d project officer at the National Institute of Diabetes and Digestive and Kidney Diseases, part of NIH. “Vitamin D use has risen sharply in the United States in the last 15 years, since it has been suggested as a remedy for a variety of conditions, including prevention of Type 2 diabetes. But we need rigorous testing to determine if vitamin D will help prevent diabetes. That’s what D2d will do.”
“Past observational studies have suggested that higher levels of vitamin D may be beneficial in preventing Type 2 diabetes, but until this large, randomized and controlled clinical trial is complete, we won’t know if taking vitamin D supplements lowers the risk of diabetes,” said Anastassios Pittas, the study’s principal investigator at Tufts Medical Center, Boston.
D2d is the first study to directly examine if a daily dose of 4,000 International Units of vitamin D — greater than a typical adult intake of 600 IUs to 800 IUs a day, but within limits deemed appropriate for clinical research by the Institute of Medicine — helps keep people with prediabetes from getting Type 2 diabetes. Based on observations from earlier studies, researchers speculate that vitamin D could reduce the diabetes risk by 25%. The study also will examine if sex, age or race affect the potential of vitamin D to reduce diabetes risk.
Researchers are recruiting volunteers to take part in D2d. Half of the participants will receive vitamin D. The other half will receive a placebo. Participants will have check-ups for the study twice a year, and will receive regular health care through their own healthcare providers.
The study will be double-blinded, so neither participants nor the study’s clinical staff will know who is receiving vitamin D and who is receiving the placebo. The study will continue until enough people have developed Type 2 diabetes to be able to make a scientifically valid comparison between diabetes development in the two groups, likely about four years.
D2d builds on previous NIH-funded studies of methods to delay or prevent Type 2 diabetes, including the Diabetes Prevention Program, which showed that, separately, lifestyle changes to lose a modest amount of weight and the drug metformin are both effective in slowing development of Type 2 diabetes in people with prediabetes.
Staples survey: More employees reporting to duty sick
FRAMINGHAM, Mass. — Nearly 90% of office workers come to work even when they know they are sick, according to the fourth annual Flu Season Survey from Staples. The findings show a growing trend when compared to last year’s findings indicating 80% of workers come to work sick, and up from 60% in the 2011 Staples survey.
“Flu season poses a big problem for businesses — each year it causes an estimated 70 million missed workdays and billions in lost office productivity. It’s critical that both employees and employers take notice and promote healthier habits,” stated Lisa Hamblet, VP facility solutions at Staples Advantage, the business-to-business division of Staples. “That can mean arming a workforce with simple products like hand sanitizer to large-scale industrial cleaning products and techniques. Diligence early in the flu season ensures health and productivity throughout the season.”
According to the survey, workers acknowledged that staying out three days when sick with the flu was appropriate. The majority of workers, however, stay out of the office for less than two days when sick, putting coworkers’ health and business productivity at risk. The primary reason most respondents cited for returning to work early was not wanting to fall behind on their workload (45%).
The survey does demonstrate that workers have a better understanding of flu prevention, however. According to the survey, 49% of respondents understand they are contagious with the flu virus for one day before symptoms develop and up to five-to-seven days after becoming sick, an improvement from 38% last year. And 57% know that flu viruses can live on a hard surface up to three days, a slight increase from last year; however, 66% of employees still only clean their desks once a week or less, up from 51% last year.
NAD recommends Maximum Human Performance tone down its advertising for MYO-X Myostatin Inhibitor
NEW YORK — The National Advertising Division last week recommended that Maximum Human Performance, which markets the dietary supplement MYO-X Myostatin Inhibitor, discontinue the advertising claims and testimonials at issue in NAD’s review.
As part of NAD’s routine monitoring efforts, and in conjunction with an initiative with the Council for Responsible Nutrition designed to expand NAD’s review of advertising claims for dietary supplements, NAD requested substantiation for claims that appeared in print advertising, on product packaging and on the advertiser’s website, including: “Research has shown that a reduction in serum myostatin levels is likely to result in clinically significant muscle gains. In my work with elite athletics I have seen firsthand the muscle enhancement impact of MYO-X when used in conjunction with intense weight training. These athletes have made vast improvements in muscle size, strength, performance and improved recovery.”
The advertiser explained that MYO-X is a beverage mix dietary supplement formulated to reduce the levels of a biological molecule called myostatin, which inhibits muscle differentiation and growth.
As support for its advertising claims, NAD noted, the company relied on scientific literature and studies that did not address whether ingesting the product did in fact reduce myostatin levels in a manner that resulted in “clinically significant” muscle gains or muscle performance benefits.
NAD noted that while the evidence in the record “shows promising results in support of the theory that ingestion of MYO-X will reduce human myostatin levels and result in a muscle enhancement impact, the evidence fails to establish the causal link necessary to support the claims at issue.”
Following its review, NAD recommended that the advertiser discontinue express claims and testimonials at issue.
The company, in its advertiser’s statement, said it “appreciated the opportunity to participate in the self-regulatory process, however, the company and the leading researcher on the benefits of Myostatin suppression disagrees with the NAD’s assessment of the underlying science and initial studies behind MYO T-12.”
However, the company said, it “will modify its claims to conform to NAD’s decision and will develop claims based on the outcome of future clinical studies.”