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Hemp Fiber Ingestion and Gut Permeability After Exercise

NCT06204666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-09-26

No results posted yet for this study

Summary

Two bioactive compounds, N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl tyramine (NFT), have been investigated for potential gut health benefits. The shells of hemp seeds are a rich source of NCT and NFT. The hypothesis for this project is that ingestion of a hemp fiber bar containing NCT and NFT will mitigate exercise-induced increases in gut permeability. This study will examine the efficacy of 2-weeks ingestion of a hemp fiber bar (high and low doses) in moderating exercise-induced gut permeability using a randomized crossover trial.

Objective #1: To conduct a randomized crossover trial using placebo-controlled, double-blind procedures with 20 cyclists who will in random order ingest a hemp fiber bar supplement (high and low doses) or placebo each day for two weeks prior to an exercise challenge (2.25 hours of intensive cycling).

Objective #2: To determine if hemp fiber bar supplementation attenuates exercise-induced gut permeability using several outcome measures including plasma lactulose to 13C mannitol (L:M) ratio and plasma intestinal fatty acid binding protein (I-FABP) as markers of gastrointestinal permeability and mucosal damage, respectively. Shifts in thousands of metabolites will be measured via untargeted metabolomics to provide additional gut permeability biomarkers and help reveal underlying mechanisms.

Conditions

  • Gastrointestinal Dysfunction
  • Metabolic Disturbance

Interventions

DIETARY_SUPPLEMENT

High Dose Hemp Fiber Bar

High dose hemp fiber bar with other ingredients

DIETARY_SUPPLEMENT

Low Dose Hemp Fiber Bar

Low dose hemp fiber bar with other ingredients

DIETARY_SUPPLEMENT

Placebo

Placebo bar with other ingredients

Sponsors & Collaborators

  • Appalachian State University

    lead OTHER

Principal Investigators

  • David C Nieman, DrPH · Appalachian State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-09
Primary Completion
2024-07-01
Completion
2024-09-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06204666 on ClinicalTrials.gov