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High Dose Hemp Fiber Bar for Gastrointestinal Dysfunction

N/A
Recruiting
Led By David C Nieman, DrPH
Research Sponsored by Appalachian State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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, generally healthy, and without gastrointestinal diseases or chronic diseases including cardiovascular disease, cancer, type 1 and 2 diabetes, rheumatoid arthritis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise
Awards & highlights

Study Summary

This trial aims to investigate the potential benefits of two compounds found in hemp seed shells, called N-trans-caffeoyl tyramine (NCT) and N-trans-feruloyl ty

Who is the study for?
This trial is for cyclists who can handle intensive cycling. They'll be testing if eating hemp fiber bars before exercising can help keep their guts healthy. Participants will eat these bars daily for two weeks and then do a tough 2.25-hour bike ride.Check my eligibility
What is being tested?
Researchers are looking at whether high or low doses of hemp fiber bars, which have special compounds from hemp seed shells, can prevent gut damage from intense exercise compared to a placebo (a bar with no active ingredients).See study design
What are the potential side effects?
Since the study involves consuming hemp fiber bars, potential side effects may include digestive changes like bloating or gas. However, specific side effects aren't listed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18-65 years old and can cycle for over 2 hours at a challenging pace.
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I am a non-smoker, generally healthy, and do not have chronic or gastrointestinal diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gut permeability
Secondary outcome measures
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)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose Hemp Fiber BarExperimental Treatment1 Intervention
5% hemp hull powder
Group II: High Dose Hemp Fiber BarExperimental Treatment1 Intervention
20% hemp hull powder
Group III: PlaceboPlacebo Group1 Intervention
0% hemp hull powder

Find a Location

Who is running the clinical trial?

Appalachian State UniversityLead Sponsor
40 Previous Clinical Trials
2,170 Total Patients Enrolled
David C Nieman, DrPHPrincipal InvestigatorAppalachian State University
13 Previous Clinical Trials
633 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction that excludes individuals who are 60 years old or older from participating in this clinical trial?

"To be eligible for this research study, participants must fall within the age range of 18 to 65 years old."

Answered by AI

Are new patients currently being enrolled in this ongoing medical study?

"As per the information provided on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The initial posting of the trial occurred on December 9th, 2023, and it was most recently updated on January 11th, 2024."

Answered by AI

What specific criteria must individuals meet to be eligible for enrollment in this clinical study?

"In order to be eligible for participation in this research, individuals must possess metabolic disorders and fall between the ages of 18 and 65. Around 27 subjects are being sought during the recruitment phase of this clinical trial."

Answered by AI

What is the total number of individuals currently under research in this clinical trial?

"Indeed, according to the details available on clinicaltrials.gov, this clinical trial is actively seeking eligible participants. The initial posting of the trial took place on December 9th, 2023 and it was last updated on January 11th, 2024. There is a target of enrolling a total of 27 participants across one study site."

Answered by AI

Who else is applying?

What site did they apply to?
Appalachian State University Human Performance Lab, North Carolina Research Campus
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have the time to do this now.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Hemp Fiber Ingestion and Gut Permeability After Exercise
2023. "Hemp Fiber Ingestion and Gut Permeability After Exercise". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06204666.
All > High Point > Greensboro
~9 spots leftby Jul 2024
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