Betaine, Exercise Performance, and Gut Permeability

NCT06392360 | Completed

• 1 other identifier: HS-24-248
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

This study will determine if ingestion of 3 g/d betaine versus placebo for two weeks prior to a 60-km cycling time trial will improve performance, moderate exercise-induced gut permeability, and improve metabolic recovery.

Conditions

Metabolic Disturbance; Permeability; Increased

Keywords

betaine; exercise; gut permeability; metabolomics

Outcome Measures

Primary Outcomes (1)

• Exercise Performance

  60-km cycling time trial

  After 2-weeks supplementation with betaine compared to after 2-weeks supplementation with placebo

Secondary Outcomes (2)

• Gut permeability

  Change from pre-supplementation levels to 5 hours post-exercise

• Changes in plasma gut permeability sugars including mannitol, lactulose, rhamnose, and sucrose from targeted metabolomics using LC-MS/MS analysis (relative intensities)

  Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise

Study Arms (2)

Betaine

EXPERIMENTAL

3 grams per day in 6 capsules, white crystalline betaine powder produced from beet molasses

Dietary Supplement: Betaine

Placebo

PLACEBO COMPARATOR

3 grams per day in 6 capsules, white cellulose powder

Dietary Supplement: Placebo

Interventions

Betaine DIETARY_SUPPLEMENT

White betaine powder

Betaine

Placebo DIETARY_SUPPLEMENT

White placebo powder

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female cyclists, ages 18-65 years, and capable of cycling 60-km in the laboratory at 70% VO2max (close to race pace).
• Non-smoker, and generally healthy and without gastrointestinal diseases (irritable bowel syndrome, chronic nausea, vomiting, and diarrhea, Crohn's disease, Celiac disease, diverticulosis) or chronic diseases including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 and 2 diabetes, rheumatoid arthritis. Categorized as "low risk" using the American College of Sports Medicine screening questionnaire.
• Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, herbs, and medications that influence inflammation (especially NSAIDs) for the duration of the 6-week study and at least a 2-week period prior to the study.
• Agree to taper their exercise routine prior to each of the 2 lab cycling sessions.
• Agree to restrict beet, wheat bran, wheat germ, and spinach diet intake and avoid other betaine supplements (other than what is provided in the supplement) during the entire 6-week study.

You may not qualify if:

• Inability to comply with study requirements.
• Females trying to become pregnant, or currently pregnant or breastfeeding.
• Nonpregnant adults who weigh less than 110 pounds.
• Any other concurrent condition which, in the opinion of the principal investigator (PI), would preclude participation in this study or interfere with compliance.
• Current diagnosis of gastrointestinal disease, cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).
• History of sensitivity to betaine and beets.
• History of adverse symptoms to lactulose, mannitol, and rhamnose sugars.

Sponsors & Collaborators

• Appalachian State University: lead
• AGRANA: collaborator

Study Sites (2)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

AppState-North Carolina Research Campus Human Performance Lab

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Betaine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• David C Nieman, DrPH

  Appalachian State Univ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigators and study participants will be blind to treatment allocation, with the betaine and placebo supplements in capsules of the same color.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized treatment, double blinded procedures, crossover

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: August 13, 2024
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: March 1, 2025, indefinitely
• Access Criteria: Upon reasonable request.

Locations

US (2)