Clinical trial NCT03123510: Effect of a Synbiotic Supplement on a High-protein Diet
Official title: Role of Synbiotics on a Weight Loss Intervention Program: Effect on Microbiome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: probiotics
prebiotics
synbiotics
obesity
Lead sponsor: South Dakota State University
Sponsor class: OTHER
Collaborators: name: Sanford Health
First posted: 2017-04-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will receive a synbiotic supplement and the other placebo capsules.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Changes in Gut microbiota associated to the synbiotic treatment
timeFrame: 3 months
Secondary outcomes:
measure: Changes in weight associated to the synbiotic treatment
timeFrame: 3 months
measure: Changes in glucose levels associated to the synbiotic treatment
timeFrame: 3 months
measure: Changes in body density associated to the synbiotic treatment
timeFrame: 3 months
measure: Changes in waist circumference associated to the synbiotic treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Brookings
country: United States
facility: South Dakota State University
state: South Dakota
Study officials:
affiliation: South Dakota State University
name: eduardo Huarte, PhD
role: PRINCIPAL_INVESTIGATOR
References: