Effect of a Synbiotic Supplement on a High-protein Diet

NCT ID: NCT03123510

Last Updated: 2017-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2017-11-01

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Synbiotic supplement

Bifidobacterium spp plus bimuno- galacto-oligosaccharides

Group Type: EXPERIMENTAL

Bifidobacterium spp plus bimuno- galacto-oligosaccharides

Intervention Type: DIETARY_SUPPLEMENT

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

placebo

sugar pills

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Bifidobacterium spp plus bimuno- galacto-oligosaccharides

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanford Health

OTHER

Sponsor Role: collaborator

South Dakota State University

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Huarte

Assistant Reseacrh Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

eduardo Huarte, PhD

Role: PRINCIPAL_INVESTIGATOR

South Dakota State University

Locations

South Dakota State University

Brookings, South Dakota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

eduardo huarte, PhD

Role: CONTACT

eduardo.huarte@sdstate.edu

6056886324

Facility Contacts

Eduardo Huarte, PhD

Role: primary

eduardo.huarte@sdstate.edu

605-688-6324

Other Identifiers

1604005

Identifier Type: -

Identifier Source: org_study_id