Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392360
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-04-26
Brief Title:
Betaine Exercise Performance and Gut Permeability
Sponsor:
Appalachian State University
Organization:
Appalachian State University
Study Overview
Official Title:
Influence of 2-Weeks DuraBeet Ingestion on Cycling Performance Gut Permeability and Metabolite Shifts
Status:
ACTIVE_NOT_RECRUITING
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:
This study will determine if ingestion of 3 gd betaine versus placebo for two weeks prior to a 60-km cycling time trial will improve performance moderate exercise-induced gut permeability and improve metabolic recovery
Detailed Description:
This study will employ a randomized crossover design Study participants will be randomized to two trials using double-blinded placebo-controlled procedures The supplement capsules betaine and placebo 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 betaine or placebo two 60-km cycling sessions and two 24-h recovery lab sessions thus 8 total lab visits Subjects will complete a COVID-19 screening questionnaire before entering the lab all visits The total amount of time subjects will be asked to volunteer for this study is about 18 hours at the Human Performance Laboratory over a 6-week period
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 Body composition and total body water will be measured using 8-point bioelectrical impedance BIA 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 for five hours 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 10 ml aliquots frozen in a minus 80C freezer until analysis
B Baseline TestingPre-Supplementation Visit 2 Subject will return the urine collection container to the lab the day after Visit 1 Body composition will be measured with the 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 betaine or placebo capsules will be given to the participants Subjects will consume 6 capsules per day 3 with the first meal in the morning and 3 more with the last meal of the day
DuraBeet Betaine supplement DuraBeet crystalline betaine is produced from beet molasses at the betaine crystallization plant in Austria according to strict European standards The white crystalline betaine will be in 6 capsules 3 gday The placebo capsules will contain a white cellulose powder in identical looking capsules
C 60-km Cycling Session Lab Visit 3 During the 3-day period prior to the 60-km 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 3 capsules of betaine or placebo and then cycle 60-km at the fastest pace possible while ingesting water alone 3 mlkg every 15 minutes Immediately following the cycling bout subjects will ingest the gut permeability sugar solution SS Blood samples will be collected at 0 h 15 h 30 h and 24-h post-exercise All urine excreted for five hours after SS ingestion will be collected in a urine collection container
Testing protocol during the lab sessions with the 60-km cycling session
1 700 am Provide blood sample delayed onset of muscle soreness DOMS rating 1-10 scale and profile of mood states ratings POMS Complete the symptom survey Turn in the 3-day food record
2 710 am Ingest 3 capsules of betaine or placebo with 1 cup water
3 730 am Start the 60-km cycling session Subjects will cycle on trainers at race pace for 60-km 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 60-km exercise sessions
4 1000 am to 100 pm Subjects will ingest the 450 mL SS within the first minute of getting off the bicycle Body composition and total body water will be measured using 8-point bioelectrical impedance BIA 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 30-h and 24-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 Body composition and total body water will be measured using 8-point BIA 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 leave the lab with instructions to complete the 5h urine collection put the container in the refrigerator and then bring the urine container to the lab the next morning Subjects will ingest 3 supplement capsules with the last meal of the day
LAB VISIT 4 Subjects will return the next morning after the cycling session to provide another blood sample turn in the 5-h urine container and complete DOMS and POMS questionnaires Body composition and total body water will be measured using 8-point BIA
D WashoutCrossoverRepeat
Subjects will engage in a 2-week washout period without the supplements crossover to the opposite supplement 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 5678 Subjects will maintain the study diet and normal exercise training routines during the 2-week washout period
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 Body composition and total body water will be measured using 8-point bioelectrical impedance BIA 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 for five hours 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 10 ml aliquots frozen in a minus 80C freezer until analysis
B Baseline TestingPre-Supplementation Visit 2 Subject will return the urine collection container to the lab the day after Visit 1 Body composition will be measured with the 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 betaine or placebo capsules will be given to the participants Subjects will consume 6 capsules per day 3 with the first meal in the morning and 3 more with the last meal of the day
DuraBeet Betaine supplement DuraBeet crystalline betaine is produced from beet molasses at the betaine crystallization plant in Austria according to strict European standards The white crystalline betaine will be in 6 capsules 3 gday The placebo capsules will contain a white cellulose powder in identical looking capsules
C 60-km Cycling Session Lab Visit 3 During the 3-day period prior to the 60-km 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 3 capsules of betaine or placebo and then cycle 60-km at the fastest pace possible while ingesting water alone 3 mlkg every 15 minutes Immediately following the cycling bout subjects will ingest the gut permeability sugar solution SS Blood samples will be collected at 0 h 15 h 30 h and 24-h post-exercise All urine excreted for five hours after SS ingestion will be collected in a urine collection container
Testing protocol during the lab sessions with the 60-km cycling session
1 700 am Provide blood sample delayed onset of muscle soreness DOMS rating 1-10 scale and profile of mood states ratings POMS Complete the symptom survey Turn in the 3-day food record
2 710 am Ingest 3 capsules of betaine or placebo with 1 cup water
3 730 am Start the 60-km cycling session Subjects will cycle on trainers at race pace for 60-km 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 60-km exercise sessions
4 1000 am to 100 pm Subjects will ingest the 450 mL SS within the first minute of getting off the bicycle Body composition and total body water will be measured using 8-point bioelectrical impedance BIA 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 30-h and 24-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 Body composition and total body water will be measured using 8-point BIA 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 leave the lab with instructions to complete the 5h urine collection put the container in the refrigerator and then bring the urine container to the lab the next morning Subjects will ingest 3 supplement capsules with the last meal of the day
LAB VISIT 4 Subjects will return the next morning after the cycling session to provide another blood sample turn in the 5-h urine container and complete DOMS and POMS questionnaires Body composition and total body water will be measured using 8-point BIA
D WashoutCrossoverRepeat
Subjects will engage in a 2-week washout period without the supplements crossover to the opposite supplement 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 5678 Subjects will maintain the study diet and normal exercise training routines during the 2-week washout period
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