MOS Prebiotic Potential in Older Adults

Healthy Clinical Trial

Official title:

The Prebiotic Potential of a Yeast Cell Wall Fraction Containing Mannooligosaccharides and β-glucans.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05939336
• Other study ID #: IRB202301046
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mannooligosaccharides (MOS) derived from baker's yeast may have prebiotic properties such as improving gastrointestinal function. The aims of this study are to determine the effect of MOS on gastrointestinal function and symptoms and fecal microbiota in older adults.

Description:

Novel prebiotics with specific microbiome targets and without adverse gastrointestinal symptoms are needed for the exploration of health benefits. This is a 3-week, open-label pilot study designed to evaluate the effect of 15 g per day of yeast-derived mannooligosaccharides on gastrointestinal symptoms, stool frequency, fecal microbiome, and urinary metabolites.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: August 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adults 50-99 years of age.

• Able to provide written informed consent in English.

• Willingness to complete all study procedures

Exclusion Criteria:

• Yeast allergy.

• Self-reported kidney disease.

• Elite athletes or long-distance runners.

• Use of antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of the screening visit.

• Current use of laxatives or antidiarrheal medications.

• Use of other investigational products within 3 months of the screening visit.

• Previously or currently being treated for any intestinal disease or condition, including IBS, Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer (self-report).

• Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection)

• Current cancer treatment

• Currently pregnant

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Mannooligosaccharides yeast extract
15 g per day of mannooligosaccharide yeast extract.

Locations

Country	Name	City	State
United States	Food Science and Human Nutrition Department, University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Lallemand Bio-Ingredients

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean daily rating of gastrointestinal symptoms	Change from baseline mean sum of daily mean rating from 0 (no symptom) to 3 (severe symptoms)	14 days