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Effect of a Synbiotic Supplement on a High-protein Diet

NCT03123510 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-04-21

No results posted yet for this 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium spp plus bimuno- galacto-oligosaccharides

Volunteers will be asked to take one probiotic capsule and one prebiotic satchel daily.

DIETARY_SUPPLEMENT

Placebo

Volunteers will be asked to take one placebo capsule and one placebo satchel daily.

Sponsors & Collaborators

  • Sanford Health

    collaborator OTHER

  • South Dakota State University

    lead OTHER

Principal Investigators

  • eduardo Huarte, PhD · South Dakota State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2017-07-31
Completion
2017-11-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03123510 on ClinicalTrials.gov