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Synbiotic supplement for Obesity

N/A
Waitlist Available
Led By eduardo Huarte, PhD
Research Sponsored by South Dakota State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any individual aged 18-80 years participating in the Profile weight loss/management diet
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Gut microbiota associated to the synbiotic treatment
Secondary outcome measures
Changes in body density associated to the synbiotic treatment
Changes in glucose levels associated to the synbiotic treatment
Changes in waist circumference associated to the synbiotic treatment
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Synbiotic supplementExperimental Treatment1 Intervention
Bifidobacterium spp plus bimuno- galacto-oligosaccharides
Group II: placeboPlacebo Group1 Intervention
sugar pills

Find a Location

Who is running the clinical trial?

South Dakota State UniversityLead Sponsor
19 Previous Clinical Trials
10,006 Total Patients Enrolled
5 Trials studying Obesity
6,132 Patients Enrolled for Obesity
Sanford HealthOTHER
48 Previous Clinical Trials
61,883 Total Patients Enrolled
1 Trials studying Obesity
250 Patients Enrolled for Obesity
eduardo Huarte, PhDPrincipal InvestigatorSouth Dakota State University

Frequently Asked Questions

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~5 spots leftby Apr 2025