Yeast Mannans and Stool Frequency

N/AActive Not RecruitingNCT06911177

University of Florida70 enrolled

Overview

Findings from an open-label pilot study of 20 adults suggested that supplementation with 15 g/day of yeast mannans was highly tolerable and demonstrated specific modulation of the microbiota and increased stool frequency in a subset of subjects reporting ≤1 stool per day at baseline. The primary aim of this randomized, double-blind, controlled trial is to determine if yeast mannan supplementation at 12 g/day will increase stool frequency in generally healthy adults reporting ≤1 stool per day. Secondary aims will determine the effect of yeast mannans on intestinal transit time, gastrointestinal symptoms, fecal microbiota composition, and urinary and fecal metabolomics.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Defecation Frequency

Interventions

Yeast mannanDIETARY_SUPPLEMENT

Yeast cell wall fraction of manno-oligosaccharides and mannoproteins supplemented at 12 g/day.

Control (placebo)DIETARY_SUPPLEMENT

A supplement containing yeast protein, yeast extract, and maltodextrin, provided at 12 g/day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adults who report a stool frequency of ≤ 1 per day. * Able to provide written informed consent in English. * Willingness to consume 1 supplement (12 g of yeast mannans or control) daily for 28 days. * Willingness to maintain their usual diet and physical activity patterns throughout the study and refrain from the consumption of any yeast-based foods (e.g. Marmite or Vegemite) or yeast extract supplements. * Willing to comply with study procedures, including stool and urine colle Exclusion Criteria: * Stool frequency of \< 3 per week * Yeast allergy * Vegan dietary pattern * Self-reported kidney disease * Elite athletes or long-distance runners * Use of antibiotic drugs within 1 month of screening * Current use of laxatives or antidiarrheal medications * Use of other investigational products within 3 months of the screening * Previously or currently being treated for intestinal diseases or conditions, including irritable bowel disease (i.e., IBS-D or IBS-mixed), Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer. * Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection). * Current cancer treatment. * Currently pregnant.

Locations (1)

Department of Food Science and Human Nutrition

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Defecation frequency

Mean daily defecation frequency

Time frame: From enrollment to the end of treatment at 6 weeks.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.