NCT06375577

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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 16, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

March 6, 2025

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

April 16, 2024

Last Update Submit

March 3, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Blood Glucose

    Frequent blood sampling for blood glucose (1ml every 5 mins for 1 hour) followed by analysis in the Biosen Analyser

    1 hour

  • Blood Lactate

    Frequent blood sampling for blood lactate (1ml every 5 mins for 1 hour) followed by analysis in the Biosen Analyser

    1 hour

  • Insulin

    Frequent blood sampling for insulin (3ml every 10 mins for 1 hour) followed by analysis in an ELISA

    1 hour

  • Gas Exchange

    Gas exchange measured throughout each 1 hour visit via a Cortex Metalyzer

    1 hour

Study Arms (3)

Voom Pocket Rocket Electro Energy Bar

EXPERIMENTAL

After at least a 1 week washout period, every participant will undergo a different intervention

Dietary Supplement: 45 grams Voom Pocket Rocket Electro Energy

Maurten gel 160

EXPERIMENTAL

After at least a1 week washout period, every participant will undergo a different intervention

Dietary Supplement: 45 grams Maurten Gel 160

SIS Go isotonic Gel

EXPERIMENTAL

After at least 1 week washout period, every participant will undergo a different intervention

Dietary Supplement: 45 grams SIS Go Isotonic Energy Gel

Interventions

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.

Voom Pocket Rocket Electro Energy Bar

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.

SIS Go isotonic Gel
45 grams Maurten Gel 160DIETARY_SUPPLEMENT

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.

Maurten gel 160

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly biological males are eligible to participate in this study. It was decided that a male only cohort would be included in this study due to the timeframe of the research (undertaken as part of a Masters by Research degree), and that including females would require a larger sample size, and thus a longer timeframe. Research has also found sex differences between responses to glucose absorption, demonstrating that females have a slower glucose absorption time, and that the menstrual cycle can significantly effect glucose absorption which would lengthen the time of research as a greater sample size would be needed with strict controls on contraception \& tracking of menstrual cycle.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lancaster University

Lancaster, Lancashire, LA1 4AT, United Kingdom

Location

Related Publications (13)

  • 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.

    PMID: 35058795BACKGROUND
  • 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.

    PMID: 15831802BACKGROUND
  • 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.

    PMID: 35717392BACKGROUND
  • 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.

    PMID: 24191965BACKGROUND
  • 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.

    PMID: 16129719BACKGROUND
  • 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.

    PMID: 34965513BACKGROUND
  • 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.

    PMID: 29489067BACKGROUND
  • 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.

    PMID: 37567949BACKGROUND
  • 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.

    PMID: 985402BACKGROUND
  • 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.

    PMID: 2926973BACKGROUND
  • 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.

    PMID: 1443110BACKGROUND
  • 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)).

    BACKGROUND
  • 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.

    PMID: 31491883BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Both the participants and investigators will be blinded to what supplement they are consuming on each visit. Each supplement will taste the same, and be placed into identical packaging, and be randomly labelled (e.g., A, B, C). This will be done to avoid potential bias.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This will be a double-blind randomised crossover design. There will be 1 group of participants who will complete all three conditions at random: Condition 1 - consume Voom Pocket Rocket. Condition 2 - consume SIS Isotonic Energy Gel. Condition 3 - consume Maurten Gel 160. All participants will undergo the same measures - blood sampling for blood glucose, blood lactate, electrolytes and insulin, and monitoring of gas exchange during each study visit.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Integrative Physiology

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 19, 2024

Study Start

July 16, 2024

Primary Completion

November 15, 2024

Study Completion

November 15, 2024

Last Updated

March 6, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations