Effect of a Synbiotic Supplement on a High-protein Diet
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Obesity
In brief
The objective of the trial is to study how a synbiotic treatment will affect weight loss and management in individuals enrolled in weight loss diet Profile®. The investigators propose to follow up 2 cohorts of Profile® subjects during 6 months. One group will receive a synbiotic treatment supplement (Bifidobacterium spp plus bimuno- galacto-oligosaccharides (B-GOS)) while the other group will receive placebo capsules. Anthropomorphic and metabolic analysis will be performed by-monthly. Fecal samples will be obtained before and after the dietary intervention and samples will be sequenced trough next generation DNA sequencing to analyze the gut microbiota. Because dietary interventions with high protein and low glycemic index have been shown to be effective in reducing weight, but has also been linked to potential colon harm due to increased fermentation of undigested protein on the colon, the investigators expect supplementation of Profile® with a synbiotic product will lead to an increased overall wellbeing without compromising weight management.
Key facts
- Study ID
- NCT03123510
- Run by
- South Dakota State University
- People needed
- 40
- Starts
- 2017-03-01
- Expected to finish
- 2017-11-01
- Last updated by the study team
- 2017-04-21
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Any individual aged 18-80 years participating in the Profile weight loss/management diet
You may not qualify if…
- Pregnant
- Requires special diets or dietary regimens
- On long term antibiotic therapy
- Diagnosed with gastrointestinal diseases (Irritable Bowel syndrome, Crohn's disease or Colitis)
- Immune compromised
- Have cancer
Where it is running
- South Dakota State University — Brookings, South Dakota, United States (enrolling)
Full record on ClinicalTrials.gov
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