Effect of a Synbiotic Supplement on a High-protein Diet

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Bifidobacterium spp plus bimuno- galacto-oligosaccharides; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: eduardo huarte, PhD; Phone Number: 6056886324; Email: eduardo.huarte@sdstate.edu

Study Locations

• United States
  • South Dakota
    • Brookings, South Dakota, United States, 57007
      • Recruiting
      • South Dakota State University
      • Contact: Eduardo Huarte, PhD; Phone Number: 605-688-6324; Email: eduardo.huarte@sdstate.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: South Dakota State University
• Collaborators: Sanford Health
• Investigators: Principal Investigator: eduardo Huarte, PhD, South Dakota State University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): July 31, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: obesity; probiotics; prebiotics; synbiotics
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 1604005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Result of the study will be made available to the scientific community trough manuscript publication. Each participant will be assigned a code to maintain patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No