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Effect of a Synbiotic Supplement on a High-protein Diet

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ClinicalTrials.gov Identifier: NCT03123510
Recruitment Status : Unknown
Verified April 2017 by Eduardo Huarte, South Dakota State University.
Recruitment status was:  Recruiting
First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
Sanford Health
Information provided by (Responsible Party):
Eduardo Huarte, South Dakota State University

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Bifidobacterium spp plus bimuno- galacto-oligosaccharides Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One group will receive a synbiotic supplement and the other placebo capsules.
Masking: Double (Participant, Care Provider)
Masking Description: Neither the volunteers nor the coaches will be aware
Primary Purpose: Basic Science
Official Title: Role of Synbiotics on a Weight Loss Intervention Program: Effect on Microbiome
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : July 31, 2017
Estimated Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Synbiotic supplement
Bifidobacterium spp plus bimuno- galacto-oligosaccharides
Dietary Supplement: Bifidobacterium spp plus bimuno- galacto-oligosaccharides
Volunteers will be asked to take one probiotic capsule and one prebiotic satchel daily.

Placebo Comparator: placebo
sugar pills
Dietary Supplement: Placebo
Volunteers will be asked to take one placebo capsule and one placebo satchel daily.




Primary Outcome Measures :
  1. Changes in Gut microbiota associated to the synbiotic treatment [ Time Frame: 3 months ]
    Stools samples will be collected and analyzed before and after the intervention and compared between groups


Secondary Outcome Measures :
  1. Changes in weight associated to the synbiotic treatment [ Time Frame: 3 months ]
    Weight (kg) will be monitored every 6 weeks

  2. Changes in glucose levels associated to the synbiotic treatment [ Time Frame: 3 months ]
    A1C (Glycated hemoglobin) levels will be monitored every 6 weeks

  3. Changes in body density associated to the synbiotic treatment [ Time Frame: 3 months ]
    body density . A DXA body scan will be performed at the beginning and end of the intervention

  4. Changes in waist circumference associated to the synbiotic treatment [ Time Frame: 3 months ]
    Waist circumference (cm) will be measured every 6 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123510


Contacts
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Contact: eduardo huarte, PhD 6056886324 eduardo.huarte@sdstate.edu

Locations
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United States, South Dakota
South Dakota State University Recruiting
Brookings, South Dakota, United States, 57007
Contact: Eduardo Huarte, PhD    605-688-6324    eduardo.huarte@sdstate.edu   
Sponsors and Collaborators
South Dakota State University
Sanford Health
Investigators
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Principal Investigator: eduardo Huarte, PhD South Dakota State University

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Responsible Party: Eduardo Huarte, Assistant Reseacrh Professor, South Dakota State University
ClinicalTrials.gov Identifier: NCT03123510     History of Changes
Other Study ID Numbers: 1604005
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Result of the study will be made available to the scientific community trough manuscript publication. Each participant will be assigned a code to maintain patient confidentiality.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eduardo Huarte, South Dakota State University:
probiotics
prebiotics
synbiotics
obesity