Status:
COMPLETED
Hemp Fiber Ingestion and Gut Permeability After Exercise
Lead Sponsor:
Appalachian State University
Conditions:
Gastrointestinal Dysfunction
Metabolic Disturbance
Eligibility:
All Genders
18-65 years
Phase:
NA
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 NC...
Detailed Description
This study will employ a randomized crossover design. Study participants will be block randomized to three trials (high and low dose hemp fibers bars or placebo) using double-blinded, placebo-controll...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
December 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06204666
Start Date
December 9 2023
End Date
September 15 2024
Last Update
September 26 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Appalachian State University Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, United States, 28081