Effect of a Synbiotic Supplement on a High-protein Diet

Obesity Clinical Trial

Official title:

Role of Synbiotics on a Weight Loss Intervention Program: Effect on Microbiome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03123510
• Other study ID #: 1604005
• Status: Recruiting
• Phase: N/A
• First received: March 29, 2017
• Last updated: April 18, 2017
• Start date: March 1, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: April 2017
• Source: South Dakota State University
• Contact: eduardo huarte, PhD
• Phone: 6056886324
• Email: eduardo.huarte[@]sdstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 1, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United States	South Dakota State University	Brookings	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
South Dakota State University	Sanford Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in weight associated to the synbiotic treatment	Weight (kg) will be monitored every 6 weeks	3 months
Secondary	Changes in glucose levels associated to the synbiotic treatment	A1C (Glycated hemoglobin) levels will be monitored every 6 weeks	3 months
Secondary	Changes in body density associated to the synbiotic treatment	body density . A DXA body scan will be performed at the beginning and end of the intervention	3 months
Secondary	Changes in waist circumference associated to the synbiotic treatment	Waist circumference (cm) will be measured every 6 weeks	3 months