Effects of ISOThrive Supplement on Body Weight in Overweight Adults
Complete Project
Title:
Effects of ISOThrive Supplement on Body Weight in Overweight Adults
Status:
Completed
Topic:
Obesity / Weight Management
Funding Source:
ISOThrive LLC
Funding Period:
2014-2015
Study Design:
Randomized controlled trial with a double-blind parallel design
Purpose:
This study examined the effects of taking a dietary prebiotic supplement for 3 months on body weight in overweight adults. Prebiotics are healthy food ingredients that are not easily digested, but promote the growth of bacteria in the gut that can benefit the body. The ISOThrive supplement’s main ingredient includes a type of dietary fiber that helps to digest food, which theoretically could cause people to eat less. The other ingredients appear to be safe and well-tolerated.
Further Study Details:
We compared the effects of daily intake for a 3-month period of the ISOThrive supplement (either version A or B, which differed in formulation) vs. a placebo on body weight in 76 overweight men and women. We asked them to keep their weight stable for the first month while taking a daily placebo (inactive substance). Then we randomly assigned each participant to 1 of 2 treatment groups. Each group received either ISOThrive (version A or B) or a placebo to take daily for 3 months. We advised them to adjust their calorie intake and/or physical activity at a level that could help them lose 1 to 2 pounds per week during this period. However, we did not ask them to restrict their dietary intake or physical activity. The primary outcome measure was body weight.
Findings:
After 12 weeks of daily intake, neither version of ISOThrive (A or B) led to any reduction in body weight, when compared to the placebo.
Eligibility:
Study participants were 18 to 75 years of age, did not use tobacco products, had a body mass index (BMI) of 25 or more, and weighed up to 350 pounds. People with diabetes or high blood pressure could take part if they were not taking medicines that could interact with the supplement.
Yale-Griffin Prevention Research Center