Effect of a Synbiotic Supplement on a High-protein Diet

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Bifidobacterium spp plus bimuno- galacto-oligosaccharides
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will receive a synbiotic supplement and the other placebo capsules.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synbiotic supplement<br>Bifidobacterium spp plus bimuno- galacto-oligosaccharides | Dietary Supplement: Bifidobacterium spp plus bimuno- galacto-oligosaccharides<br>* Volunteers will be asked to take one probiotic capsule and one prebiotic satchel daily.<br>|
| Placebo Comparator: placebo<br>sugar pills | Dietary Supplement: Placebo<br>* Volunteers will be asked to take one placebo capsule and one placebo satchel daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Gut microbiota associated to the synbiotic treatment | Stools samples will be collected and analyzed before and after the intervention and compared between groups | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, prebiotics, synbiotics, obesity