Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375577
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-04-16
Brief Title:
Speed of Glucose Absorption
Sponsor:
Lancaster University
Organization:
Lancaster University
Study Overview
Official Title:
Evaluating the Speed of Carbohydrate Supplement Absorption in an Athletic Population
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this study is to look at how fast commercially available supplements containing carbohydrate can get into the bloodstream If carbohydrate in the form of glucose gets into the blood faster this can provide an instant energy source and help fuel the body during exercise We will be testing three supplements namely Voom Pocket Rocket SIS Go Isotonic Energy Gel and Maurten Gel 160 Each participant will complete all three conditions consuming one of each supplement at random per condition The study requires participation from male runners cyclists and triathletes who are aged between 18-35
Each visit will take approximately 1 hour and 30 minutes and three experimental visits per participant The study will involve frequent blood sampling and the continuous monitoring of gas exchange oxygencarbon dioxide Blood sampling via cannulation will be used to analyse the lactate glucose and insulin content of the blood Gas exchange will measure the oxygen breathed in and carbon dioxide breathed out throughout the study
The investigators plan to carry out the study on 16 participants who will be a mix of male runners cyclists and triathletes
Each visit will take approximately 1 hour and 30 minutes and three experimental visits per participant The study will involve frequent blood sampling and the continuous monitoring of gas exchange oxygencarbon dioxide Blood sampling via cannulation will be used to analyse the lactate glucose and insulin content of the blood Gas exchange will measure the oxygen breathed in and carbon dioxide breathed out throughout the study
The investigators plan to carry out the study on 16 participants who will be a mix of male runners cyclists and triathletes
Detailed Description:
The aim of this study is to investigate and compare the speed of delivery of three commercially available carbohydrate supplements during a 1 hour modified glucose tolerance test This study will be a randomised double-blind crossover in design Participants will be required to attend the Human Performance Laboratory at Lancaster University on three separate visits During each visit participants will be required to consume one of three commercially available carbohydrate supplements namely Maurten Gel 160 MAU Voom Pocket Rocket Electro Energy Bar PR and SIS Go Isotonic Energy Gel SIS Each consumable will be blinded to both the researchers and participants flavoured the same lemon and lime and placed into identical packaging with anonymised labelling to minimise the risk of bias The supplements will be matched for carbohydrate content 45 grams Blinding of supplements will be completed offsite by people not in the research team and followed strict food and hygiene protocols Each participant will complete all three conditions consuming one of each supplement at random per condition
Each visit will involve frequent venous blood sampling for glucose lactate and insulin An anterograde venous cannula will be inserted into a vein in the antecubital fossa of the arm by a qualified member of the research team This is a less invasive alternative to an arterial cannula whilst still allowing for accurate metabolic measures to be taken This method is also less painful than inserting a retrograde cannula which can cause significant discomfort
Once the anterograde venous cannula is inserted and secured in place a resting measurement of blood will be taken 1ml of blood taken to measure glucose and lactate and 3ml for insulin Participants will then be required to consume one of the three carbohydrate energy supplements Once the supplement had been consumed continuous gas analysis will begin to analyse gas exchange to non-invasively measure substrate utilisation This signals the start of the test and a timer will be set for 1 hour
Throughout the test blood sampling will be taken in frequent intervals 1ml of blood sampled every 5 minutes to check for glucose and lactate and 3ml of blood sampled every 10 minutes for insulin Gas exchange will be continuously measured to non-invasively measure substrate utilization in the muscle via indirect calorimetry which determines energy expenditure by measuring the bodys oxygen consumption and carbon dioxide production The measurement is based on the assumption that the volume of oxygen VO2 consumed is used to oxidise fuels and the volume of carbon dioxide VCO2 produced is a by-product of substrate utilisation
After the study visit analysis will be conducted assessing how each of the three supplements effect blood glucose blood lactate insulin and gas exchange
Each visit will involve frequent venous blood sampling for glucose lactate and insulin An anterograde venous cannula will be inserted into a vein in the antecubital fossa of the arm by a qualified member of the research team This is a less invasive alternative to an arterial cannula whilst still allowing for accurate metabolic measures to be taken This method is also less painful than inserting a retrograde cannula which can cause significant discomfort
Once the anterograde venous cannula is inserted and secured in place a resting measurement of blood will be taken 1ml of blood taken to measure glucose and lactate and 3ml for insulin Participants will then be required to consume one of the three carbohydrate energy supplements Once the supplement had been consumed continuous gas analysis will begin to analyse gas exchange to non-invasively measure substrate utilisation This signals the start of the test and a timer will be set for 1 hour
Throughout the test blood sampling will be taken in frequent intervals 1ml of blood sampled every 5 minutes to check for glucose and lactate and 3ml of blood sampled every 10 minutes for insulin Gas exchange will be continuously measured to non-invasively measure substrate utilization in the muscle via indirect calorimetry which determines energy expenditure by measuring the bodys oxygen consumption and carbon dioxide production The measurement is based on the assumption that the volume of oxygen VO2 consumed is used to oxidise fuels and the volume of carbon dioxide VCO2 produced is a by-product of substrate utilisation
After the study visit analysis will be conducted assessing how each of the three supplements effect blood glucose blood lactate insulin and gas exchange
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