Recruiting

Synbiotic Supplement

Sponsor:

South Dakota State University

Code:

NCT03123510

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Bifidobacterium spp plus bimuno- galacto-oligosaccharides

Placebo

Study Details

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.

Conditions

Obesity

Study ID

NCT03123510

Start date

Mar 1, 2017

Status verified date

Apr, 2017

Completion date

Nov 1, 2017

Anticipated

Primary completion date

Jul 31, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Synbiotic supplement

Bifidobacterium spp plus bimuno- galacto-oligosaccharides

placebo comparator: placebo

sugar pills

Interventions

Bifidobacterium spp plus bimuno- galacto-oligosaccharides

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

Placebo

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

Primary outcome measure

  • Changes in Gut microbiota associated to the synbiotic treatment [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

South Dakota State University

Recruiting

Brookings, South Dakota, United States, 57007

Contacts

More Information

Sponsor

South Dakota State University

Last update posted

Apr 21, 2017

Last verified

Apr, 2017

Keywords

  • probiotics
  • prebiotics
  • synbiotics
  • obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by South Dakota State University on 2017-04-21.