Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648967
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Impact of Different Carbohydrate Feedings on a Hydrogen Breath Curve and Self-reported Gastrointestinal Complaints
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hydrogen Breath Test Results After Consuming Fructose At Baseline and After Protein Supplementation
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GI distress is widely prevalent among athletes ranging from 30 to 90 in recreationally and professionally active athletes As the recipient of nutrients the gastrointestinal GI tract plays an important role in athleticism The following pilot project aims to better understand if a fructose load after hiking under heat stress will result in a meaningful hydrogen breath elevation as a marker for malabsorption in healthy participants and if supplementation of a multi-ingredient fermented whey supplement will result in a different hydrogen breath response rate after a heat stress hiking test
Detailed Description:
The present study aims to examine the difference between two different boluses of carbohydrate after a hiking test in the heat on fructose malabsorption measured by determining a hydrogen breath curve as well as taking multiple self-reported gastrointestinal symptom ratings
In addition the study aims to evaluate the difference in hydrogen breath response and gastrointestinal symptom ratings using one of the previously determined carbohydrate boluses after supplementing a multi-ingredient whey protein for 3 weeks followed by 2 more weeks of supplementation
The objective of the study is to answer following questions
Question 1 Does treadmill hiking in the heat combined with a glucose-fructose feeding ie ration 21 or 12 result in different hydrogen breath malabsorption curves and GI symptoms
Question 2 Is there a difference in hydrogen breath test curves and self-reported gastrointestinal symptom ratings over time after 3 and 5 weeks of supplementation when consuming a multi-ingredient whey supplement compared to baseline
No study procedures will start until informed consent has been obtained
The familiarization If participants meet all the inclusion criteria and choose to participate participants will start with the familiarization to get a better feeling of the type of exercise they need to perform Participants will perform an Ebbeling Submax Test a two-stage walking protocol lasting 10 minutes After this VO2max is determined from the steady state heartrate HR and speed following the last 4 minutes of the second stage at 5 grade Steady state HR is defined as over 120 bpm and 5 bpm range over at least 2 minutes
Test protocol The night prior to each exercise test date the participant will be asked to consume a standardized low-fiber meal which will be provided to them After 10pm participants will be asked not to consume any calorie containing items and to only consume water Participants will also be asked to avoid exercising the day prior to testing The day of the test participants will arrive fasted and they will perform a 60-minute hiking protocol in a warm environment The exercise consists of hiking on a treadmill in a warm environment 30-35C while reaching an exercise intensity of 70 5 bpm of the subjects HR max calculated by the Karvonen method as described below Which is an intensity in which the subject has an elevated breathing frequency but is still able to talk The treadmill has a 5 incline and participants will start at a speed informed by their Ebbeling test results after this each minute the speed will be increased with 05 mph until the heartrate reflects the target HR range in case walking speed is maxed out treadmill incline can be altered as well Heart rate and speed will be continuously monitored if speed needs to be adjusted at a later phase during the protocol because heartrate is not within the targeted HR-range this will be recorded to allow for exact copying the protocol during the next exercise sessions The exercise will be divided in 3 blocks of 20 minutes during which the participants work towards reaching their 70 HR max during an 18-minute period followed with 2 minutes active rest if needed before the next block The carbohydrate feeding will consist of 3 carbohydrate gels with 25 grams of carbohydrate with a 21 ratio glucose and fructose during followed by 500 mL water during test 1 and consumption of 25 grams of glucose in 100 mL at the start of test 2 followed by 50 grams of fructose after the test mixed in 400 mL no food will be provided after the heat stress test but water can be consumed ad libitum Heart rate will be monitored using a heart rate monitor attached via chest strap Monitor will be placed by the participant beneath all clothing with the monitor at chest level xyphoid process with guidance from the research team If the participant requests help a research team member will assist
Hydrogen Breath Analysis Hydrogen measurements will be issued at baseline -65min post-exercise 0min and with 30-min intervals post-exercise at 306090120150 and 180 min Hydrogen breath analysis is a minimally invasive procedure which requires the participant to breath normally but exhale into a gas sample bag until the 250mL bag is filled
Gastrointestinal Distress Accompanying the hydrogen breath test at -65min 0min 60min 120min and 180mi a GSRS questionnaire will also be given The GSRS consists of 15 items and typically assesses GI complaints in the seven days before survey administration however instructions will be modified to request symptoms experienced at the time of administration The GSRS will be administered digitally in this study and will require less than 5 minutes to complete The 15 items 1 Upper abdominal pain 2 Heartburn 3 Acid reflux 4 Hunger pains 5 Nausea 6 Rumbling in the stomach 7 Bloated 8 Burping 9 Passing gas or flatus 10 Constipation 11 Diarrhea 12 Loose stools 13 Hard stools 14 Urgent need to defecate 15 Incomplete emptying of bowels assessed the extent of discomforts of GI symptoms based on a 7-point Likert scale where higher scores reflect more severe discomforts A total score with no complaints would result in 15 points whereas the maximal score would result in 105 points
Baseline testing exercise test 1 and test 2 Participants will be scheduled for 2 separate test visits including a 60 min hiking test followed by 3 hours of hydrogen breath data and gastrointestinal symptoms data collection The two visits set one week apart will be completed No supplementation between these visits will be consumed and participants will be advised to mimic exercise and diet the day prior to testing On both visits participants will arrive fasted and will complete the testing protocol as described below At the end of the second visit instructions for the 3-week supplementation will be given to the participants and the product will be sent home with them
Testing after supplementation exercise test 3 and test 4 After these baseline visits a 3-week protein supplementation protocol will be completed followed by again a test visit followed by an additional 2-week protein supplementation protocol and a final test visit The commercially available protein supplement Biotis Fermentis is a multi-ingredient fermented whey supplement with 8 g of protein and 4 g of soluble fiber galactooligosaccharides per serving
In addition the study aims to evaluate the difference in hydrogen breath response and gastrointestinal symptom ratings using one of the previously determined carbohydrate boluses after supplementing a multi-ingredient whey protein for 3 weeks followed by 2 more weeks of supplementation
The objective of the study is to answer following questions
Question 1 Does treadmill hiking in the heat combined with a glucose-fructose feeding ie ration 21 or 12 result in different hydrogen breath malabsorption curves and GI symptoms
Question 2 Is there a difference in hydrogen breath test curves and self-reported gastrointestinal symptom ratings over time after 3 and 5 weeks of supplementation when consuming a multi-ingredient whey supplement compared to baseline
No study procedures will start until informed consent has been obtained
The familiarization If participants meet all the inclusion criteria and choose to participate participants will start with the familiarization to get a better feeling of the type of exercise they need to perform Participants will perform an Ebbeling Submax Test a two-stage walking protocol lasting 10 minutes After this VO2max is determined from the steady state heartrate HR and speed following the last 4 minutes of the second stage at 5 grade Steady state HR is defined as over 120 bpm and 5 bpm range over at least 2 minutes
Test protocol The night prior to each exercise test date the participant will be asked to consume a standardized low-fiber meal which will be provided to them After 10pm participants will be asked not to consume any calorie containing items and to only consume water Participants will also be asked to avoid exercising the day prior to testing The day of the test participants will arrive fasted and they will perform a 60-minute hiking protocol in a warm environment The exercise consists of hiking on a treadmill in a warm environment 30-35C while reaching an exercise intensity of 70 5 bpm of the subjects HR max calculated by the Karvonen method as described below Which is an intensity in which the subject has an elevated breathing frequency but is still able to talk The treadmill has a 5 incline and participants will start at a speed informed by their Ebbeling test results after this each minute the speed will be increased with 05 mph until the heartrate reflects the target HR range in case walking speed is maxed out treadmill incline can be altered as well Heart rate and speed will be continuously monitored if speed needs to be adjusted at a later phase during the protocol because heartrate is not within the targeted HR-range this will be recorded to allow for exact copying the protocol during the next exercise sessions The exercise will be divided in 3 blocks of 20 minutes during which the participants work towards reaching their 70 HR max during an 18-minute period followed with 2 minutes active rest if needed before the next block The carbohydrate feeding will consist of 3 carbohydrate gels with 25 grams of carbohydrate with a 21 ratio glucose and fructose during followed by 500 mL water during test 1 and consumption of 25 grams of glucose in 100 mL at the start of test 2 followed by 50 grams of fructose after the test mixed in 400 mL no food will be provided after the heat stress test but water can be consumed ad libitum Heart rate will be monitored using a heart rate monitor attached via chest strap Monitor will be placed by the participant beneath all clothing with the monitor at chest level xyphoid process with guidance from the research team If the participant requests help a research team member will assist
Hydrogen Breath Analysis Hydrogen measurements will be issued at baseline -65min post-exercise 0min and with 30-min intervals post-exercise at 306090120150 and 180 min Hydrogen breath analysis is a minimally invasive procedure which requires the participant to breath normally but exhale into a gas sample bag until the 250mL bag is filled
Gastrointestinal Distress Accompanying the hydrogen breath test at -65min 0min 60min 120min and 180mi a GSRS questionnaire will also be given The GSRS consists of 15 items and typically assesses GI complaints in the seven days before survey administration however instructions will be modified to request symptoms experienced at the time of administration The GSRS will be administered digitally in this study and will require less than 5 minutes to complete The 15 items 1 Upper abdominal pain 2 Heartburn 3 Acid reflux 4 Hunger pains 5 Nausea 6 Rumbling in the stomach 7 Bloated 8 Burping 9 Passing gas or flatus 10 Constipation 11 Diarrhea 12 Loose stools 13 Hard stools 14 Urgent need to defecate 15 Incomplete emptying of bowels assessed the extent of discomforts of GI symptoms based on a 7-point Likert scale where higher scores reflect more severe discomforts A total score with no complaints would result in 15 points whereas the maximal score would result in 105 points
Baseline testing exercise test 1 and test 2 Participants will be scheduled for 2 separate test visits including a 60 min hiking test followed by 3 hours of hydrogen breath data and gastrointestinal symptoms data collection The two visits set one week apart will be completed No supplementation between these visits will be consumed and participants will be advised to mimic exercise and diet the day prior to testing On both visits participants will arrive fasted and will complete the testing protocol as described below At the end of the second visit instructions for the 3-week supplementation will be given to the participants and the product will be sent home with them
Testing after supplementation exercise test 3 and test 4 After these baseline visits a 3-week protein supplementation protocol will be completed followed by again a test visit followed by an additional 2-week protein supplementation protocol and a final test visit The commercially available protein supplement Biotis Fermentis is a multi-ingredient fermented whey supplement with 8 g of protein and 4 g of soluble fiber galactooligosaccharides per serving
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None