- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03731065
Exogenous Oxidation of Fructose-glucose Mixtures During Running
December 7, 2019 updated by: Javier Gonzalez, University of Bath
Examining Exogenous Carbohydrate Oxidation From Glucose, Multiple Transportable Carbohydrates and Hydrogel Carbohydrate Drinks During Endurance Running
The aim of this study is to characterise exogenous carbohydrate oxidation rates during exercise, when ingesting glucose (polymers) only, compared to glucose-fructose mixtures, and glucose-fructose mixtures ingested in hydrogel form.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bath, United Kingdom, BA2 7AY
- Department for Health, University of Bath
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Maximal oxygen consumption > 50 ml.kg-1.min-1
- > 1 year training in endurance running or triathlon
- No current injury or injury within the last three months
- No history of cardiac or metabolic disease such as coronary heart disease or diabetes
- No current or history of gastrointestinal issues
- Successful completion of the physical activity readiness questionnaire (PAR-Q)
Exclusion Criteria:
- Female
- Untrained in endurance running
- Current injury or injury within the past three months
- History of cardiac or metabolic disease such as coronary heart disease or diabetes
- History of or current gastrointestinal issues such as irritable bowel syndrome
- Unable to replicate diet and training for 3 and 5 days respectively prior to each experimental visit.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fructose-maltodextrin ingestion
Ingestion of fructose and maltodextrin (glucose polymers) at a rate of 90 g carbohydrate per hour during two hours of treadmill running at 60%VO2peak.
|
Fructose plus maltodextrin in a ratio of 1:1.4,
diluted in water to produce a 16% carbohydrate solution.
|
Experimental: Fructose-maltodextrin hydrogel ingestion
Ingestion of fructose and maltodextrin (glucose polymers) encapsulated in alginate-pectin hydrogel, drinks at a rate of 90 g carbohydrate per hour during two hours of treadmill running at 60%VO2peak.
|
Fructose plus maltodextrin in a ratio of 1:1.4,
encapsulated in an alginate-pectin hydrogel diluted in water to produce a 16% carbohydrate solution.
|
Active Comparator: Glucose-maltodextrin ingestion
Ingestion of glucose and maltodextrin (glucose polymers) at a rate of 90 g carbohydrate per hour during two hours of treadmill running at 60%VO2peak.
|
Glucose plus maltodextrin in a ratio of 1:1.4,
diluted in water to produce a 16% carbohydrate solution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak exogenous carbohydrate oxidation rate
Time Frame: 120 minutes
|
Peak exogenous carbohydrate oxidation rate during 120 min of treadmill running.
Measured using isotope ratio mass spectrometry and reported in grams per minute
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total carbohydrate oxidation
Time Frame: 120 minutes
|
Total carbohydrate oxidation during 120 min of treadmill running.
Measured using indirect calorimetry and reported in grams.
|
120 minutes
|
Ratings of gastrointestinal discomfort
Time Frame: 120 minutes
|
Subjective ratings of gastrointestinal discomfort during 120 min of treadmill running. Measured using a 9-item questionnaire on a scale of 1 to 7, where 1 = No discomfort at all and 7 = very severe discomfort. Items: Stomach; Heartburn; Acid reflux; Nausea; Rumbling; Bloated; Burping; Passing gas; Bowel movement. |
120 minutes
|
Total fat oxidation
Time Frame: 120 minutes
|
Total fat oxidation during 120 min of treadmill running.
Measured using indirect calorimetry and reported in grams.
|
120 minutes
|
Plasma insulin concentrations
Time Frame: 120 minutes
|
Plasma insulin concentrations during 120 min of treadmill running.
Measured using enzyme-linked immunosorbent assay and reported in pmol/L.
|
120 minutes
|
Plasma glucose concentrations
Time Frame: 120 minutes
|
Plasma lactate concentrations during 120 min of treadmill running.
Measured using colourimetric assay and reported in mmol/L.
|
120 minutes
|
Plasma lactate concentrations
Time Frame: 120 minutes
|
Plasma lactate concentrations during 120 min of treadmill running.
Measured using colourimetric assay and reported in mmol/L.
|
120 minutes
|
Plasma non-esterified fatty acid concentrations
Time Frame: 120 minutes
|
Plasma insulin concentrations during 120 min of treadmill running.
Measured using colourimetric assay and reported in umol/L.
|
120 minutes
|
Ratings of perceived exertion
Time Frame: 120 minutes
|
Subjective ratings of perceived exertion using the Borg scale (1982) during 120 min of treadmill running.
Measured on a scale of 6 to 20, where 6 = no exertion at all, and 20 = maximal exertion.
|
120 minutes
|
Heart rate
Time Frame: 120 minutes
|
Heart rate during treadmill running measured by telemetry and reported in beats per minute.
|
120 minutes
|
Rate of oxygen consumption
Time Frame: 120 minutes
|
Rate of oxygen consumption during 120 min of treadmill running.
Measured using indirect calorimetry and reported in litres per minute.
|
120 minutes
|
Rate of carbon dioxide production
Time Frame: 120 minutes
|
Rate of carbon dioxide production during 120 min of treadmill running.
Measured using indirect calorimetry and reported in litres per minute.
|
120 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 14, 2018
Primary Completion (Actual)
October 30, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
November 2, 2018
First Submitted That Met QC Criteria
November 2, 2018
First Posted (Actual)
November 6, 2018
Study Record Updates
Last Update Posted (Actual)
December 10, 2019
Last Update Submitted That Met QC Criteria
December 7, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- MSES 17/18-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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