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.
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
- Conditions the study is for
- Gastrointestinal Dysfunction, Metabolic Disturbance
- 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
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).
- 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.
- 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.
- 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:
- 7:00 am: Provide blood sample, DOMS rating (1-10 scale), and POMS. Complete the symptom survey. Turn in the 3-day food record.
- 7:10 am: Ingest 1 supplement bar with 1 cup water.
- 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.
- ~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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| High Dose Hemp Fiber Bar | Experimental | 20% hemp hull powder Receives: Dietary Supplement: High Dose Hemp Fiber Bar |
| Low Dose Hemp Fiber Bar | Experimental | 5% hemp hull powder Receives: Dietary Supplement: Low Dose Hemp Fiber Bar |
| Placebo | Placebo comparator | 0% hemp hull powder Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted12 Jan 2024
- Study start9 Dec 2023
- Primary completion1 Jul 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David C Nieman, DrPH, Principal investigator, Appalachian State University
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of 2-Weeks Hemp Fiber Ingestion on Gut Permeability and Metabolite Shifts After Vigorous Exercise
- ClinicalTrials.gov ID
- NCT06204666
- Acronym / sponsor ID
- HS-24-86
- Keywords
- hemp fiber, exercise, gut permeability, metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Study start
- 9 Dec 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
- 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.
- 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.
- 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:
- 7:00 am: Provide blood sample, DOMS rating (1-10 scale), and POMS. Complete the symptom survey. Turn in the 3-day food record.
- 7:10 am: Ingest 1 supplement bar with 1 cup water.
- 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.
- ~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.
- 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.
- 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized treatment, double blinded procedures, crossover
| Arm | Type | Receives |
|---|---|---|
| High Dose Hemp Fiber Bar | Experimental | Dietary Supplement: High Dose Hemp Fiber Bar20% hemp hull powder |
| Low Dose Hemp Fiber Bar | Experimental | Dietary Supplement: Low Dose Hemp Fiber Bar5% hemp hull powder |
| Placebo | Placebo comparator | Dietary Supplement: Placebo0% hemp hull powder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dose Hemp Fiber BarHigh dose hemp fiber bar with other ingredients | Dietary supplement | High Dose Hemp Fiber Bar |
| Low Dose Hemp Fiber BarLow dose hemp fiber bar with other ingredients | Dietary supplement | Low Dose Hemp Fiber Bar |
| PlaceboPlacebo bar with other ingredients | Dietary supplement | Placebo |
Primary outcome
Gut permeability
Time frame: Change from pre-supplementation levels to 5 hours post-exercise
Urine concentrations of post-exercise lactulose/13C mannitol ratio (L/M)
1 secondary outcome
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)
Time frame: Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: Yes. Will share data upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Nieman, DrPH principal investigator
Appalachian State University
1 site in 1 country: see every site and its status.
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.