Effect of a Synbiotic Supplement on a High-protein Diet

Not Applicable

• Conditions: Obesity
• Interventions: Dietary Supplement: Bifidobacterium spp plus bimuno- galacto-oligosaccharides; Dietary Supplement: Placebo

• Registration Number: NCT03123510
• Lead Sponsor: South Dakota State University

Brief 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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-29
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Study First Posted: 2017-04-21
• Last Update Posted: 2017-04-21
• Primary Completion: 2017-07-31
• Study Completion: 2017-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Any individual aged 18-80 years participating in the Profile weight loss/management diet

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synbiotic supplement	Bifidobacterium spp plus bimuno- galacto-oligosaccharides	Bifidobacterium spp plus bimuno- galacto-oligosaccharides
placebo	Placebo	sugar pills

Primary Outcome Measures

Name	Time	Method
Changes in Gut microbiota associated to the synbiotic treatment	3 months	Stools samples will be collected and analyzed before and after the intervention and compared between groups

Secondary Outcome Measures

Name	Time	Method
Changes in body density associated to the synbiotic treatment	3 months	body density . A DXA body scan will be performed at the beginning and end of the intervention
Changes in glucose levels associated to the synbiotic treatment	3 months	A1C (Glycated hemoglobin) levels will be monitored every 6 weeks
Changes in waist circumference associated to the synbiotic treatment	3 months	Waist circumference (cm) will be measured every 6 weeks
Changes in weight associated to the synbiotic treatment	3 months	Weight (kg) will be monitored every 6 weeks

Trial Locations

Locations (1)

South Dakota State University; 🇺🇸 Brookings, South Dakota, United States