Effect of a Synbiotic Supplement on a High-protein Diet

NCT03123510 | Unknown

• 1 other identifier: 1604005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

probiotics; prebiotics; synbiotics; obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in weight associated to the synbiotic treatment

  3 months

• Changes in glucose levels associated to the synbiotic treatment

  3 months

• Changes in body density associated to the synbiotic treatment

  3 months

• Changes in waist circumference associated to the synbiotic treatment

  3 months

Study Arms (2)

Synbiotic supplement

EXPERIMENTAL

Bifidobacterium spp plus bimuno- galacto-oligosaccharides

Dietary Supplement: Bifidobacterium spp plus bimuno- galacto-oligosaccharides

placebo

PLACEBO COMPARATOR

sugar pills

Dietary Supplement: Placebo

Interventions

Bifidobacterium spp plus bimuno- galacto-oligosaccharides DIETARY_SUPPLEMENT

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

Synbiotic supplement

Placebo DIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any individual aged 18-80 years participating in the Profile weight loss/management diet

You may not qualify if:

• 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

Sponsors & Collaborators

• South Dakota State University: lead
• Sanford Health: collaborator

Study Sites (1)

South Dakota State University

Brookings, South Dakota, 57007, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• eduardo Huarte, PhD

  South Dakota State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

eduardo huarte, PhD

CONTACT

6056886324; eduardo.huarte@sdstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Neither the volunteers nor the coaches will be aware
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Reseacrh Professor

Model Details: One group will receive a synbiotic supplement and the other placebo capsules.

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 21, 2017
• Study Start: March 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: November 1, 2017
• Last Updated: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)