- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02605291
Dietary Macronutrient Manipulation and Substrate Oxidation During Exercise
The Effect of Dietary Macronutrient Manipulation and Glycogen Depleting Exercise on Substrate Oxidation at Rest and During Exercise
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Birmingham, United Kingdom, B15 2TT
- School of Sport Exercise and Rehabilitation Sciences, University of Birmingham
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
|---|---|
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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.
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A diet with altered macronutrient content will be provided to participants on days 4-6 of experimental arm 1.
Participants will perform interval treadmill running exercise on days 4 and 5 of all experimental arms.
Participants will perform steady state treadmill running exercise on day 7 of all experimental arms.
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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.
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Participants will perform interval treadmill running exercise on days 4 and 5 of all experimental arms.
Participants will perform steady state treadmill running exercise on day 7 of all experimental arms.
A diet with a different macronutrient content compared to arm 1 will be provided to participants on days 4-6 of experimental arm 2.
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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.
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Participants will perform interval treadmill running exercise on days 4 and 5 of all experimental arms.
Participants will perform steady state treadmill running exercise on day 7 of all experimental arms.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Muscle glycogen concentration after dietary macronutrient manipulation
Time Frame: Day 7 of all experimental arms
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Muscle glycogen concentration will be measured after the dietary macronutrient manipulation intervention.
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Day 7 of all experimental arms
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of fat oxidation at rest (g/min)
Time Frame: For 20 min on Day 7 of all experimental arms
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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).
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For 20 min on Day 7 of all experimental arms
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Rate of fat oxidation during exercise (g/min)
Time Frame: During 60 min of exercise on day 7 of all experimental arms
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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).
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During 60 min of exercise on day 7 of all experimental arms
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Rate of carbohydrate oxidation at rest (g/min)
Time Frame: For 20 min on Day 7 of all experimental arms
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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).
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For 20 min on Day 7 of all experimental arms
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Rate of carbohydrate oxidation during exercise (g/min)
Time Frame: During 60 min of exercise on day 7 of all experimental arms
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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).
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During 60 min of exercise on day 7 of all experimental arms
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Blood glucose concentration
Time Frame: At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms.
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Blood glucose concentration will be assessed in blood samples taken during exercise.
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At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms.
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Blood insulin concentration
Time Frame: At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
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Blood insulin concentration will be assessed in blood samples taken during exercise.
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At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
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Blood fatty acid concentration
Time Frame: At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
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Blood fatty acid concentration will be assessed in blood samples taken during exercise.
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At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
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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
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IMTG utilisation during exercise (or change in IMTG content pre-post exercise) will be measured by comparing the IMTG content before and after exercise.
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IMTG content measured just before and immediately after 60min of exercise on Day 7 of all experimental arms
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gareth A Wallis, PhD, University of Birmingham
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ERN_15-0963
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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