Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204666
Status:
COMPLETED
Last Update Posted:
2024-01-12
First Post:
2023-12-19
Brief Title:
Hemp Fiber Ingestion and Gut Permeability After Exercise
Sponsor:
Appalachian State University
Organization:
Appalachian State University
Study Overview
Official Title:
Influence of 2-Weeks Hemp Fiber Ingestion on Gut Permeability and Metabolite Shifts After Vigorous Exercise
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 225 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 LM 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
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 225 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 LM 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 orientationbaseline testing pre-and post-supplementation blood sample collections 2 weeks supplementation with high and low dose hemp fiber bar supplements or placebo and three 225 h cycling sessions thus 9 total lab visits
A 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 19 g and rhamnose 1 g in a total of 450 ml water SS calculated osmolality 69 mosmolkg An increase in the post-exercise lactulose13C mannitol ratio LM 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 kcalkg 15 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 80C freezer until analysis
B Baseline TestingPre-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
C 225 h Cycling Session Lab Visit 3 During the 3-day period prior to the 225-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 225 h at high intensity 70 VO2max while ingesting water alone 3 mlkg every 15 minutes Immediately following the cycling bout subjects will ingest the SS Blood samples will be collected at 0 h 15 h and 30 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 225-h cycling session
1 700 am Provide blood sample DOMS rating 1-10 scale and POMS Complete the symptom survey Turn in the 3-day food record
2 710 am Ingest 1 supplement bar with 1 cup water
3 730 am Start the 225 h cycling session Subjects will cycle on trainers at 70 VO2max race pace for 225 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 mlkg water every 15 min No other beverage or food containing energy or nutrients will be allowed during the 225-h exercise sessions
4 1000 am to 100 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 15-h and 30-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 mlkg during the 15 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 15 h post-exercise blood draw subjects will ingest a Boost beverage 7 kcalkg 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
D WashoutCrossoverRepeat
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 456 Subjects will maintain the study diet and normal exercise training routines during the 2-week washout period
E SECOND WashoutCrossoverRepeat
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 789
A 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 19 g and rhamnose 1 g in a total of 450 ml water SS calculated osmolality 69 mosmolkg An increase in the post-exercise lactulose13C mannitol ratio LM 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 kcalkg 15 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 80C freezer until analysis
B Baseline TestingPre-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
C 225 h Cycling Session Lab Visit 3 During the 3-day period prior to the 225-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 225 h at high intensity 70 VO2max while ingesting water alone 3 mlkg every 15 minutes Immediately following the cycling bout subjects will ingest the SS Blood samples will be collected at 0 h 15 h and 30 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 225-h cycling session
1 700 am Provide blood sample DOMS rating 1-10 scale and POMS Complete the symptom survey Turn in the 3-day food record
2 710 am Ingest 1 supplement bar with 1 cup water
3 730 am Start the 225 h cycling session Subjects will cycle on trainers at 70 VO2max race pace for 225 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 mlkg water every 15 min No other beverage or food containing energy or nutrients will be allowed during the 225-h exercise sessions
4 1000 am to 100 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 15-h and 30-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 mlkg during the 15 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 15 h post-exercise blood draw subjects will ingest a Boost beverage 7 kcalkg 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
D WashoutCrossoverRepeat
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 456 Subjects will maintain the study diet and normal exercise training routines during the 2-week washout period
E SECOND WashoutCrossoverRepeat
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 789
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None