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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Dietary supplement: Fructose-maltodextrin
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.
Dietary supplement: Fructose-maltodextrin hydrogel
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.
Dietary supplement: Glucose-maltodextrin
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bath

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Birmingham

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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