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Gastrointestinal DysfunctionNCT06204666

Hemp Fiber Ingestion and Gut Permeability After Exercise

A study testing High Dose Hemp Fiber Bar and Low Dose Hemp Fiber Bar in people with Gastrointestinal Dysfunction and Metabolic Disturbance, run by Appalachian State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
High Dose Hemp Fiber Bar and Low Dose Hemp Fiber Bar
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited States
Study dates
9 Dec 2023to 15 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Appalachian State University Human Performance Lab, North Carolina Research Campus

    Kannapolis, North Carolina, 28081

Other trials in United States

About this study

Official title: Influence of 2-Weeks Hemp Fiber Ingestion on Gut Permeability and Metabolite Shifts After Vigorous Exercise

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.

Read the 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-controlled procedures. The supplement bars will be coded by the sponsor, with the double-blind code held until after all study samples have been analyzed. Subjects will come to the lab for orientation/baseline testing, pre-and post-supplementation blood sample collections (2 weeks supplementation with high and low dose hemp fiber bar supplements or placebo), and three 2.25 h cycling sessions (thus 9 total lab visits).

  1. Orientation (Visit #1). Subjects will report to the lab in an overnight fasted state. Subjects will voluntarily sign IRB-approved consent forms and complete questionnaires (delayed onset of muscle soreness or DOMS, Profile of Mood States or POMS). Demographic, health, and training histories will be acquired with questionnaires. A blood sample will be collected. Subjects will ingest a standardized sugar solution containing lactulose 5 g, 13C mannitol 100 mg, mannitol 1.9 g, and rhamnose 1 g in a total of 450 ml water (SS, calculated osmolality 69 mosmol/kg). An increase in the post-exercise lactulose/13C mannitol ratio (L/M) will be used as an indicator of increased gut permeability. All urine excreted from 0-5 h post SS ingestion will be collected in a urine collection container. Subjects will be urged to drink water after the first hour of the test to ensure adequate urine output. The Boost beverage will be consumed at 7 kcal/kg 1.5 h post SS ingestion (to simulate what occurs post-exercise). The urine collection container will be placed in the refrigerator until they are returned to the lab the next day. The total urine volume will be measured with four 50 ml aliquots frozen in a minus 80°C freezer until analysis.
  2. Baseline Testing/Pre-Supplementation (Visit #2). Subject will return urine collection container to the HPL the day after Visit #1. Body composition will be measured with the seca BIA and Bod Pod body composition analyzer (Life Measurement, Concord, CA). Study participants will be tested for maximal aerobic capacity (VO2max) during a graded, cycling test with continuous metabolic monitoring with the Cosmed CPET metabolic device (Cosmed, Rome, Italy). A 2-week supply of high dose or low dose hemp fiber bars or placebo bars will be given to the participants. Subjects will consume 2 bars per day, one with the first meal in the morning and the second bar with the last meal of the day.
  3. 2.25 h Cycling Session (Lab Visit #3): During the 3-day period prior to the 2.25-h cycling session, subjects will taper exercise training and ingest a moderate-carbohydrate diet using a food list restricting high fat foods, visible fats, and caffeine. Subjects will record all food and beverage intake in a 3-day food record with macro- and micro-nutrient intake calculated using the ESHA Food Processor nutrient analysis software program. Study participants will report to the Human Performance Lab in an overnight fasted state and provide a blood sample, ingest the supplement (1 hemp fiber bar or placebo bar), and then cycle 2.25 h at high intensity (70% VO2max) while ingesting water alone (3 ml/kg every 15 minutes). Immediately following the cycling bout, subjects will ingest the SS. Blood samples will be collected at 0 h, 1.5 h, and 3.0 h post-exercise. All urine excreted from 0-5 h after SS ingestion will be collected in a urine collection container.

Testing protocol during the lab sessions with the 2.25-h cycling session:

  1. 7:00 am: Provide blood sample, DOMS rating (1-10 scale), and POMS. Complete the symptom survey. Turn in the 3-day food record.
  2. 7:10 am: Ingest 1 supplement bar with 1 cup water.
  3. 7:30 am: Start the 2.25 h cycling session. Subjects will cycle on trainers at 70% VO2max (~race pace) for 2.25 hours. Oxygen consumption, carbon dioxide production, respiratory exchange ratio, and ventilation will be measured using the Cosmed Quark CPET metabolic cart every 30 minutes. Subjects will consume 3 ml/kg water every 15 min. No other beverage or food containing energy or nutrients will be allowed during the 2.25-h exercise sessions.
  4. ~10:00 am to 1:00 pm: Ingest the 450 mL SS within the first minute of getting off the bicycle. All urine excreted from 0-5 h after SS ingestion will be collected in a urine collection container. Blood samples will be taken via venipuncture immediately after completing the cycling session, and then 1.5-h and 3.0-h post-exercise. Subjects will be allowed to shower and change clothes. The DOMS and POMS questionnaires will be administered each time blood samples are collected. Subjects will ingest no food or beverage other than water (7 ml/kg during the 1.5 h post-exercise period; this will take into account the 450 ml sugar solution; no water will be ingested during the first hour post-SS intake). After the 1.5 h post-exercise blood draw, subjects will ingest a Boost beverage (7 kcal/kg body weight). Another blood sample will be collected 3-h post-exercise. Afterwards, subjects will be allowed to stay in the lab to complete the 5h urine collection (preferred procedure) or leave the lab and return later in the day to turn in the 5h urine container. Upon request, subjects can also leave the lab, finish the 5h urine collection, put the container in the refrigerator, and then bring the urine container to the lab the next morning.
  5. Washout/Crossover/Repeat

Subjects will engage in a 2-week washout period without the supplements, crossover to the next treatment arm, and then repeat all procedures except for the consent process, completion of the medical health questionnaire, body composition testing, and VO2 max testing (Lab visits #4,5,6). Subjects will maintain the study diet and normal exercise training routines during the 2-week washout period.

  1. SECOND Washout/Crossover/Repeat

Subjects will engage in a 2-week washout period without the supplements, crossover to the next treatment arm, and then repeat all procedures except for the consent process, completion of the medical health questionnaire, body composition testing, and VO2 max testing (Lab visits #7,8,9).

Being tested
High Dose Hemp Fiber Bar, Low Dose Hemp Fiber Bar, Placebo
Keywords
hemp fiber, exercise, gut permeability, metabolomics
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Dose Hemp Fiber BarDietary supplement

    High dose hemp fiber bar with other ingredients

  • Low Dose Hemp Fiber BarDietary supplement

    Low dose hemp fiber bar with other ingredients

  • PlaceboDietary supplement

    Placebo bar with other ingredients

Study groups in NCT06204666
Study groupRoleWhat they receive
High Dose Hemp Fiber BarExperimental20% hemp hull powder
Receives: Dietary Supplement: High Dose Hemp Fiber Bar
Low Dose Hemp Fiber BarExperimental5% hemp hull powder
Receives: Dietary Supplement: Low Dose Hemp Fiber Bar
PlaceboPlacebo comparator0% hemp hull powder
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gut permeability

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

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

Secondary outcomes (1)
  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)

    Targeted metabolomics to assess plasma metabolites (short chain fatty acids) from LC-MS/MS analysis (relative intensities)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2024
  2. Study start9 Dec 2023
  3. Primary completion1 Jul 2024
  4. Study completion15 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized treatment, double blinded procedures, crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06204666
Sponsor's protocol ID
HS-24-86
Status last verified
Sep 2024
First submitted
19 Dec 2023
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Will share data upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing High Dose Hemp Fiber Bar and Low Dose Hemp Fiber Bar in people with Gastrointestinal Dysfunction and Metabolic Disturbance, run by Appalachian State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gut permeability (time frame: Change from pre-supplementation levels to 5 hours post-exercise). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.

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