Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05742516
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-02-02
Brief Title:
Does Galactooligosaccharide Enhance Nutrient Availability
Sponsor:
University of Bath
Organization:
University of Bath
Study Overview
Official Title:
Does Galactooligosaccharide Supplementation Enhance Nutrient Availability in Physically Active Individuals
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Current evidence suggests that the amount of ingested carbohydrate that we can use for energy during exercise is limited by absorption levels in the gut Thus strategies to increase the amount of ingested carbohydrate our body can use are of great interest
Recent evidence has shown we may be able to use more of the ingested carbohydrate during exercise when supplementing with probiotics good bacteria for our gut It is currently unknown whether the food for these good bacteria known as prebiotics can induce a similar effect Therefore the purpose of this study is to understand if supplementation with the prebiotic Galactooligosaccharide onwards referred to as BIMUNO can increase the use of ingested carbohydrate during exercise We also aim to understand if BIMUNO can enhance the availability of other nutrients such as vitamins and minerals
Participant will attend 8 laboratory sessions at the University of Bath The first session is a screening visit lasting no more than 30 minutes This can take place online over the phone or in-person and the remaining 7 sessions will take place in a University of Bath laboratory The next session is preliminary testing and familiarisation approx 2-25 hours The remaining 6 visits 4 exercise trials 2 baseline sample collection visits will be split across 3 main blocks of the study each lasting 28 days Following preliminary testing you will be randomised into supplementing with either BIMUNO or placebo Block 1 will then begin with you attending the laboratory for a baseline sample collection visit after which you will begin supplementation for the next 28 days After this 28-day period you will complete two exercise trials details below The ambient temperature in these trials separated by 3 days will differ 20 35C and will occur in a random order The second block termed the washout period will be a 28-day period where you will take neither BIMUNO nor the placebo The third block will then commence and will be identical to block 1 - the only difference being you will take the alternative supplement
Recent evidence has shown we may be able to use more of the ingested carbohydrate during exercise when supplementing with probiotics good bacteria for our gut It is currently unknown whether the food for these good bacteria known as prebiotics can induce a similar effect Therefore the purpose of this study is to understand if supplementation with the prebiotic Galactooligosaccharide onwards referred to as BIMUNO can increase the use of ingested carbohydrate during exercise We also aim to understand if BIMUNO can enhance the availability of other nutrients such as vitamins and minerals
Participant will attend 8 laboratory sessions at the University of Bath The first session is a screening visit lasting no more than 30 minutes This can take place online over the phone or in-person and the remaining 7 sessions will take place in a University of Bath laboratory The next session is preliminary testing and familiarisation approx 2-25 hours The remaining 6 visits 4 exercise trials 2 baseline sample collection visits will be split across 3 main blocks of the study each lasting 28 days Following preliminary testing you will be randomised into supplementing with either BIMUNO or placebo Block 1 will then begin with you attending the laboratory for a baseline sample collection visit after which you will begin supplementation for the next 28 days After this 28-day period you will complete two exercise trials details below The ambient temperature in these trials separated by 3 days will differ 20 35C and will occur in a random order The second block termed the washout period will be a 28-day period where you will take neither BIMUNO nor the placebo The third block will then commence and will be identical to block 1 - the only difference being you will take the alternative supplement
Detailed Description:
None
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