Effect of a Synbiotic Supplement on a High-protein Diet
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bifidobacterium spp plus bimuno- galacto-oligosaccharides
Placebo
Sponsored by

About this trial
This is an interventional basic science trial for Obesity focused on measuring probiotics, prebiotics, synbiotics, obesity
Eligibility Criteria
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
Sites / Locations
- South Dakota State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Synbiotic supplement
placebo
Arm Description
Bifidobacterium spp plus bimuno- galacto-oligosaccharides
sugar pills
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in weight associated to the synbiotic treatment
Weight (kg) will be monitored every 6 weeks
Changes in glucose levels associated to the synbiotic treatment
A1C (Glycated hemoglobin) levels will be monitored every 6 weeks
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
Changes in waist circumference associated to the synbiotic treatment
Waist circumference (cm) will be measured every 6 weeks
Full Information
NCT ID
NCT03123510
First Posted
March 29, 2017
Last Updated
April 18, 2017
Sponsor
South Dakota State University
Collaborators
Sanford Health
1. Study Identification
Unique Protocol Identification Number
NCT03123510
Brief Title
Effect of a Synbiotic Supplement on a High-protein Diet
Official Title
Role of Synbiotics on a Weight Loss Intervention Program: Effect on Microbiome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Anticipated)
Study Completion Date
November 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Dakota State University
Collaborators
Sanford Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
probiotics, prebiotics, synbiotics, obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group will receive a synbiotic supplement and the other placebo capsules.
Masking
ParticipantCare Provider
Masking Description
Neither the volunteers nor the coaches will be aware
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Synbiotic supplement
Arm Type
Experimental
Arm Description
Bifidobacterium spp plus bimuno- galacto-oligosaccharides
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
sugar pills
Intervention Type
Dietary Supplement
Intervention Name(s)
Bifidobacterium spp plus bimuno- galacto-oligosaccharides
Intervention Description
Volunteers will be asked to take one probiotic capsule and one prebiotic satchel daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Volunteers will be asked to take one placebo capsule and one placebo satchel daily.
Primary Outcome Measure Information:
Title
Changes in Gut microbiota associated to the synbiotic treatment
Description
Stools samples will be collected and analyzed before and after the intervention and compared between groups
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in weight associated to the synbiotic treatment
Description
Weight (kg) will be monitored every 6 weeks
Time Frame
3 months
Title
Changes in glucose levels associated to the synbiotic treatment
Description
A1C (Glycated hemoglobin) levels will be monitored every 6 weeks
Time Frame
3 months
Title
Changes in body density associated to the synbiotic treatment
Description
body density . A DXA body scan will be performed at the beginning and end of the intervention
Time Frame
3 months
Title
Changes in waist circumference associated to the synbiotic treatment
Description
Waist circumference (cm) will be measured every 6 weeks
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
eduardo huarte, PhD
Phone
6056886324
Email
eduardo.huarte@sdstate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
eduardo Huarte, PhD
Organizational Affiliation
South Dakota State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Dakota State University
City
Brookings
State/Province
South Dakota
ZIP/Postal Code
57007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Huarte, PhD
Phone
605-688-6324
Email
eduardo.huarte@sdstate.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Effect of a Synbiotic Supplement on a High-protein Diet
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