Speed of Absorption

Healthy Clinical Trial

Official title:

Evaluating the Speed of Carbohydrate Supplement Absorption in an Athletic Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06375577
• Other study ID #: LMS-24-Dean-1
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Lancaster University
• Contact: Ewan T Dean
• Phone: +44 07807816414
• Email: e.dean1[@]lancaster.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (oxygen/carbon 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.

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 blood sampling for glucose, lactate and insulin, via a retrograde venous cannula will inserted into the dorsal surface of their non-dominant arm by a qualified member of the research team. It is fitted in the opposite direction to an anterograde cannula which allows for the collection of distal blood samples where arterial venous shunting is likely to occur. The participants hand and lower forearm will be then placed into a heated box to allow for the arterialisation of the blood. This is a less invasive alternative to arterial cannulisation whilst still allowing for accurate metabolic measures to be taken.

Once the retrograde 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 body's 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Aged between 18-35 years

• Males

• Tier 2 runners, cyclists, and triathletes; local level representation, training ~ 3 times per week, training with a purpose to compete, identify with a specific sport, limited skill development

• BMI between 18.5-24.9 - based on healthy weight range for BMI as per NHS and BMI of recreational to elite long-distance runners

Exclusion Criteria:

• Allergies to any listed ingredients on any supplements.

• Diabetes (type 1 or 2)

• Any medical conditions

• Smokers

• Anyone using drugs or medication

• Anyone consuming alcohol within 24 hours of the study

• Exercise must be restricted within 24 hours of the study

• Caffeine must not be consumed within 24 hours of testing as it can significantly enhance carbohydrate oxidation rates

• Diets including high-carbohydrate-low-fat (HCLF), low-carbohydrate-high-fat (LCHF), ketogenic, and/or glycogen manipulation diets

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• 45 grams Voom Pocket Rocket Electro Energy
Participants will be required to consume 45 grams (in carbohydrates) of the Voom Pocket Rocket Electro Energy on one of the three experimental visits. Participants will have blood glucose, blood lactate, and insulin sampled throughout a 1-hour modified oral glucose tolerance test. Gas exchange will also be monitored throughout the 1-hour study visit.
• 45 grams SIS Go Isotonic Energy Gel
Participants will be required to consume 45 grams (in carbohydrates) SIS Isotonic Energy Gel on one of the three experimental visits. Participants will have blood glucose, blood lactate, and insulin sampled throughout a 1-hour modified oral glucose tolerance test. Gas exchange will also be monitored throughout the 1-hour study visit.
• 45 grams Maurten Gel 160
Participants will be required to consume 45 grams (in carbohydrates) Maurten Gel 160 on one of the three experimental visits. Participants will have blood glucose, blood lactate, and insulin sampled throughout a 1-hour modified oral glucose tolerance test. Gas exchange will also be monitored throughout the 1-hour study visit.

Locations

Country	Name	City	State
United Kingdom	Lancaster University	Lancaster	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
Lancaster University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (13)

Brooks DC, Black PR, Arcangeli MA, Aoki TT, Wilmore DW. The heated dorsal hand vein: an alternative arterial sampling site. JPEN J Parenter Enteral Nutr. 1989 Jan-Feb;13(1):102-5. doi: 10.1177/0148607189013001102. — View Citation

Copeland KC, Kenney FA, Nair KS. Heated dorsal hand vein sampling for metabolic studies: a reappraisal. Am J Physiol. 1992 Nov;263(5):E1010-4. doi: 10.1152/ajpendo.1992.263.5.E1010. — View Citation

Delsoglio M, Achamrah N, Berger MM, Pichard C. Indirect Calorimetry in Clinical Practice. J Clin Med. 2019 Sep 5;8(9):1387. doi: 10.3390/jcm8091387. — View Citation

Horie I, Abiru N, Eto M, Sako A, Akeshima J, Nakao T, Nakashima Y, Niri T, Ito A, Nozaki A, Haraguchi A, Akazawa S, Mori Y, Ando T, Kawakami A. Sex differences in insulin and glucagon responses for glucose homeostasis in young healthy Japanese adults. J Diabetes Investig. 2018 Nov;9(6):1283-1287. doi: 10.1111/jdi.12829. Epub 2018 Mar 30. — View Citation

Lin G, Siddiqui R, Lin Z, Blodgett JM, Patel SN, Truong KN, Mariakakis A. Blood glucose variance measured by continuous glucose monitors across the menstrual cycle. NPJ Digit Med. 2023 Aug 11;6(1):140. doi: 10.1038/s41746-023-00884-x. — View Citation

Marc A, Sedeaud A, Guillaume M, Rizk M, Schipman J, Antero-Jacquemin J, Haida A, Berthelot G, Toussaint JF. Marathon progress: demography, morphology and environment. J Sports Sci. 2014;32(6):524-32. doi: 10.1080/02640414.2013.835436. Epub 2013 Nov 5. — View Citation

McGuire EA, Helderman JH, Tobin JD, Andres R, Berman M. Effects of arterial versus venous sampling on analysis of glucose kinetics in man. J Appl Physiol. 1976 Oct;41(4):565-73. doi: 10.1152/jappl.1976.41.4.565. — View Citation

McKay AKA, Stellingwerff T, Smith ES, Martin DT, Mujika I, Goosey-Tolfrey VL, Sheppard J, Burke LM. Defining Training and Performance Caliber: A Participant Classification Framework. Int J Sports Physiol Perform. 2022 Feb 1;17(2):317-331. doi: 10.1123/ijspp.2021-0451. Epub 2022 Dec 29. — View Citation

Rauch CE, McCubbin AJ, Gaskell SK, Costa RJS. Feeding Tolerance, Glucose Availability, and Whole-Body Total Carbohydrate and Fat Oxidation in Male Endurance and Ultra-Endurance Runners in Response to Prolonged Exercise, Consuming a Habitual Mixed Macronutrient Diet and Carbohydrate Feeding During Exercise. Front Physiol. 2022 Jan 4;12:773054. doi: 10.3389/fphys.2021.773054. eCollection 2021. — View Citation

Williams PT, Satariano WA. Relationships of age and weekly running distance to BMI and circumferences in 41,582 physically active women. Obes Res. 2005 Aug;13(8):1370-80. doi: 10.1038/oby.2005.166. — View Citation

Wirnitzer K, Boldt P, Wirnitzer G, Leitzmann C, Tanous D, Motevalli M, Rosemann T, Knechtle B. Health status of recreational runners over 10-km up to ultra-marathon distance based on data of the NURMI Study Step 2. Sci Rep. 2022 Jun 18;12(1):10295. doi: 10.1038/s41598-022-13844-4. — View Citation

Wrench, E., 2021. Determining the Dose-Response Relationship Between Exercise and Glycaemic Control and Examining Exercise as a Treatment for Type 2 Diabetes (Master's thesis, Lancaster University (United Kingdom)).

Yeo SE, Jentjens RL, Wallis GA, Jeukendrup AE. Caffeine increases exogenous carbohydrate oxidation during exercise. J Appl Physiol (1985). 2005 Sep;99(3):844-50. doi: 10.1152/japplphysiol.00170.2005. Epub 2005 Apr 14. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose	Frequent blood sampling for blood glucose (1ml every 5 mins for 1 hour) followed by analysis in the Biosen Analyser	1 hour
Primary	Blood Lactate	Frequent blood sampling for blood lactate (1ml every 5 mins for 1 hour) followed by analysis in the Biosen Analyser	1 hour
Primary	Insulin	Frequent blood sampling for insulin (3ml every 10 mins for 1 hour) followed by analysis in an ELISA	1 hour
Primary	Gas Exchange	Gas exchange measured throughout each 1 hour visit via a Cortex Metalyzer	1 hour

External Links

•   Maurten Gel 160
•   SIS Go Isotonic Energy Gel
•   Voom Pocket Rocket Electro Energy