Dietary Macronutrient Manipulation and Substrate Oxidation During Exercise

October 10, 2018 updated by: University of Birmingham

The Effect of Dietary Macronutrient Manipulation and Glycogen Depleting Exercise on Substrate Oxidation at Rest and During Exercise

This study will investigate the effect of dietary macronutrient manipulation on glycogen (stored carbohydrate) levels in the muscle and substrate oxidation during exercise. The investigators will investigate the hypothesis that manipulating the macronutrient content of the diet will alter the levels of glycogen in the muscle and, in turn, substrate oxidation during exercise.

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.

Detailed Description

One way to help reduce body fat is to expend more energy from the oxidation of fat as a fuel. Exercise is one way to increase fat oxidation. The extent to which exercise facilitates the use of fat as a fuel may be influenced by an individual's dietary intake.

This study aims to establish the effect of dietary macronutrient manipulation on muscle glycogen levels and substrate oxidation during exercise. Participants will undertake three separate trial periods. During each trial period participants will consume a diet containing different macronutrient compositions. For each of the trials the investigators will assess how the macronutrient composition of the diet affects muscle glycogen level and substrate oxidation during 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.
13

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
      • Birmingham, United Kingdom, B15 2TT
        • School of Sport Exercise and Rehabilitation Sciences, University of Birmingham

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Good general health
  • Non-smoking - currently and for the past 5 years
  • Fitness - V̇O2max 40-60 ml/kg/min
  • Body mass index (20-25 kg/m2)

Exclusion Criteria:

  • Known or suspected intolerance to the dietary interventions or their stated ingredients.
  • Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
  • Previous participation in this study.
  • Recent history (within the last year) of alcohol or other substance abuse.
  • An employee of the sponsor or the study site or members of their immediate family.
  • Abnormal / extreme habitual dietary practice / intake
  • Recent (≤3 months) dietary practice that may be deemed as low and/or high in macronutrients will be excluded.
  • The taking of any prescribed medication

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: Single

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.
Experimental: Experimental arm 1
One of three 7-day study arms consisting of 3 days of standardised diet followed by 3 days of dietary macronutrient manipulation and 1 day of experimental testing.
Other: Diet with a different macronutrient content A
A diet with altered macronutrient content will be provided to participants on days 4-6 of experimental arm 1.
Other: Interval treadmill running exercise
Participants will perform interval treadmill running exercise on days 4 and 5 of all experimental arms.
Other: Steady state treadmill running exercise
Participants will perform steady state treadmill running exercise on day 7 of all experimental arms.
Experimental: Experimental arm 2
One of three 7-day study arms consisting of 3 days of standardised diet followed by 3 days of dietary macronutrient manipulation and 1 day of experimental testing.
Other: Interval treadmill running exercise
Participants will perform interval treadmill running exercise on days 4 and 5 of all experimental arms.
Other: Steady state treadmill running exercise
Participants will perform steady state treadmill running exercise on day 7 of all experimental arms.
Other: Diet with a different macronutrient content B
A diet with a different macronutrient content compared to arm 1 will be provided to participants on days 4-6 of experimental arm 2.
Experimental: Experimental arm 3
One of three 7-day study arms consisting of 3 days of standardised diet followed by 3 days of dietary macronutrient manipulation and 1 day of experimental testing.
Other: Interval treadmill running exercise
Participants will perform interval treadmill running exercise on days 4 and 5 of all experimental arms.
Other: Steady state treadmill running exercise
Participants will perform steady state treadmill running exercise on day 7 of all experimental arms.
Other: Diet with a different macronutrient content C
A diet with a different macronutrient content compared to arms 1 and 2 will be provided to participants on days 4-6 of experimental arm 3.

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
Muscle glycogen concentration after dietary macronutrient manipulation
Time Frame: Day 7 of all experimental arms
Muscle glycogen concentration will be measured after the dietary macronutrient manipulation intervention.
Day 7 of all experimental arms

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
Rate of fat oxidation at rest (g/min)
Time Frame: For 20 min on Day 7 of all experimental arms
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) at rest will be measured using indirect calorimetry to calculate the rate of fat oxidation at rest (g/min).
For 20 min on Day 7 of all experimental arms
Rate of fat oxidation during exercise (g/min)
Time Frame: During 60 min of exercise on day 7 of all experimental arms
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) during exercise will be measured using indirect calorimetry to calculate the rate of fat oxidation during exercise (g/min).
During 60 min of exercise on day 7 of all experimental arms
Rate of carbohydrate oxidation at rest (g/min)
Time Frame: For 20 min on Day 7 of all experimental arms
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) at rest will be measured using indirect calorimetry to calculate the rate of carbohydrate oxidation at rest (g/min).
For 20 min on Day 7 of all experimental arms
Rate of carbohydrate oxidation during exercise (g/min)
Time Frame: During 60 min of exercise on day 7 of all experimental arms
Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) during exercise will be measured using indirect calorimetry to calculate the rate of carbohydrate oxidation during exercise (g/min).
During 60 min of exercise on day 7 of all experimental arms
Blood glucose concentration
Time Frame: At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms.
Blood glucose concentration will be assessed in blood samples taken during exercise.
At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms.
Blood insulin concentration
Time Frame: At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
Blood insulin concentration will be assessed in blood samples taken during exercise.
At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
Blood fatty acid concentration
Time Frame: At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
Blood fatty acid concentration will be assessed in blood samples taken during exercise.
At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
Change in intramuscular triglyceride (IMTG) content after exercise
Time Frame: IMTG content measured just before and immediately after 60min of exercise on Day 7 of all experimental arms
IMTG utilisation during exercise (or change in IMTG content pre-post exercise) will be measured by comparing the IMTG content before and after exercise.
IMTG content measured just before and immediately after 60min of exercise on Day 7 of all experimental arms

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 Birmingham

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.
Lucozade Ribena Suntory

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gareth A Wallis, PhD, 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

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.
January 1, 2016

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.
June 1, 2017

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.
June 1, 2017

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 6, 2015

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 11, 2015

First Posted (Estimate)

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 16, 2015

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.
October 11, 2018

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.
October 10, 2018

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.
October 1, 2018

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.
  • ERN_15-0963

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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