NCT03123510

Effect of a Synbiotic Supplement on a High-protein Diet

Role of Synbiotics on a Weight Loss Intervention Program: Effect on Microbiome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: South Dakota State University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The investigators intend to recruit 40 new Profile® members and to randomly divide them into 2 groups; Group A will follow the conventional coaching and diet plan, while group B will also receive a daily dose of the synbiotic treatment (group A will receive a placebo supplement similar in appearance and caloric content to the synbiotic treatment). Volunteers will be followed for 6 months, and weight loss, waist circumference, BMI and glucose and cholesterol levels will be assessed monthly. Dual-energy x-ray absorptiometry (DXA) will be used to analyze body composition at the beginning and end of the dietary interventions. Fecal samples will be obtained at the beginning and the end of the study. Because both our pre- and probiotic supplements have been reported to increase the concentration of satiating bacteria-derived metabolites, we expect that the individuals on the group B (synbiotic supplement) will experience a higher weight loss as well as more significant drops in glucose and cholesterol levels. Because synbiotic treatments have been reported to facilitate GI passage, the investigators expect volunteers in group B will also report improved bowels movements and general wellbeing.

Conditions

• Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bifidobacterium spp plus bimuno- galacto-oligosaccharides	Volunteers will be asked to take one probiotic capsule and one prebiotic satchel daily.
DIETARY_SUPPLEMENT	Placebo	Volunteers will be asked to take one placebo capsule and one placebo satchel daily.

Timeline

• Start date: 2017-03-01
• Primary completion: 2017-07-31
• Completion: 2017-11-01
• First posted: 2017-04-21
• Last updated: 2017-04-21

Locations

1 site across 1 country: United States