Hemp Fiber Ingestion and Gut Permeability After Exercise

NCT06204666 | Completed

• 1 other identifier: HS-24-86
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hemp fiber; exercise; gut permeability; metabolomics

Outcome Measures

Primary Outcomes (1)

• Gut permeability

  Urine concentrations of post-exercise lactulose/13C mannitol ratio (L/M)

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

Secondary Outcomes (1)

• Changes in plasma hemp fiber-related metabolites including acetic acid, propionic acid, and butyric acid 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 (3)

High Dose Hemp Fiber Bar

EXPERIMENTAL

20% hemp hull powder

Dietary Supplement: High Dose Hemp Fiber Bar

Low Dose Hemp Fiber Bar

EXPERIMENTAL

5% hemp hull powder

Dietary Supplement: Low Dose Hemp Fiber Bar

Placebo

PLACEBO COMPARATOR

0% hemp hull powder

Dietary Supplement: Placebo

Interventions

High Dose Hemp Fiber Bar DIETARY_SUPPLEMENT

High dose hemp fiber bar with other ingredients

High Dose Hemp Fiber Bar

Low Dose Hemp Fiber Bar DIETARY_SUPPLEMENT

Low dose hemp fiber bar with other ingredients

Low Dose Hemp Fiber Bar

Placebo DIETARY_SUPPLEMENT

Placebo bar with other ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female cyclists, ages 18-65 years, and capable of cycling 2.25 h in the laboratory at 60% watts maximum (close to long-distance 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 non-steroidal antiinflammatory drugs or NSAIDs) for the duration of the 10-week study and at least a 2-week period prior to the study.
• Agree to taper your exercise routine prior to each of the 3 lab cycling sessions (as if preparing for a race event).
• Agree to restrict (i.e., avoid high amounts of) black pepper, red pepper, garlic, curry, and other strong spices during the 3-day period prior to each lab visit.

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).
• Sensitivity to hemp fiber.
• History of intolerance to cow's milk and lactose.
• History of adverse symptoms to low amounts of lactulose, mannitol, and rhamnose sugars (low calorie and poorly absorbed sugars).

Sponsors & Collaborators

• Appalachian State University: lead

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• David C Nieman, DrPH

  Appalachian State University

  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 hemp fiber-based supplement bars and placebo supplement bar of the same texture, taste, and look.
• 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: December 19, 2023
• First Posted: January 12, 2024
• Study Start: December 9, 2023
• Primary Completion: July 1, 2024
• Study Completion: September 15, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: January 2024, indefinitely
• Access Criteria: Will share information upon reasonable request.

Locations

US (1)