Effects of the FOS Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes: A Randomized, Placebo-controlled, Crossover Trial
Complete Project
Title:
Effects of the FOS Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes: A Randomized, Placebo-controlled, Crossover Trial
Status:
Completed
Topic:
Cardiovascular Health / Endothelial Function*;Complementary & Alternative Medicine;Diabetes / Insulin Resistance
This study tested the effects of a phototherapy product on certain measures of health in people at risk for type 2 diabetes. According to recent research, certain wavelengths of light appear to activate an enzyme in the mitochondria of cells, which in turn appears to activate signaling pathways in the body. A recent study of mice with diabetes showed that elevated activity of this enzyme led to reduced blood glucose levels and insulin resistance.
Further Study Details:
This study compared the effects of 12 weeks each of a phototherapy patch product vs. placebo patches on markers of cardio-metabolic risk and sleep quality. The product used 2 small patches worn on the skin that, when activated by body heat, reflected low levels of infrared and visible light to stimulate the skin’s surface. They did not contain any drugs or herbal compounds, and did not put any chemicals in the body. All tests and study products were provided free of charge.Outcome measures included hemoglobin A1C, insulin sensitivity, serum lipids, C-reactive protein, endothelial function (blood flow measured in the right arm using ultrasound), body composition, and sleep quality. For each of the two treatment periods, measures were assessed at baseline and 12 weeks.
Findings:
Data analysis has not been completed.
Eligibility:
Adults who met the following criteria:were older than 40 years of age (if women, they must be postmenopausal)were non-smokerswere overweighthad higher-than-normal blood glucose levels, but not diabeteswere willing to do the following over an 8-month period: visit the PRC at Griffin Hospital 5 times for clinical testswear 2 small patches on their abdomen each day for about 6 monthsreport their food and beverage intake on certain days
Yale-Griffin Prevention Research Center