- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05330481
Body Weight and Carb Metabolism
Exploring the Role of Body Mass in Exogenous Carbohydrate Oxidation Rates During Exercise
Whilst theoretically, body size should influence the capacity for intestinal carbohydrate absorption and thus exogenous oxidation rates during exercise, there is currently little empirical evidence to support this hypothesis. Accordingly, current nutrition guidelines for carbohydrate intake during exercise do not take body mass into account. Therefore, there is a need to establish whether body mass is related to exogenous carbohydrate oxidation rates during exercise. If such a relationship is established, this would lay the foundation to revise the current sports nutrition guidelines regarding carbohydrate intake during exercise.
The aims of this study are, therefore, to: 1) establish whether larger individuals display higher rates of exogenous carbohydrate oxidation than smaller individuals; and 2) establish if such a difference can be explained by the higher absolute exercise intensity, and thus the energy demand of exercise. It is hypothesised that larger individuals will demonstrate higher exogenous carbohydrate oxidation rates than smaller individuals, and that this difference will be partly (but not completely) diminished when the absolute intensity of exercise is matched.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bath, United Kingdom, BA2 7AY
- Department for Health, University of Bath
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Able to cycle continuously for 2 hours at a moderate intensity
- VO2max of between 40-75 mL/kg/min
- Fat-mass index (determined by dual energy x-ray absorptiometry) < 5.5 kg·m-2
Exclusion Criteria:
- Diagnosed disorders of the gastrointestinal tract (e.g. crohn's, colitis etc.)
- People following a low-carbohydrate, high-fat diet
- Pregnant or lactating
- Diagnosed cardiovascular disease
- Possible symptoms of cardiovascular disease
- Diagnosis of diabetes of any type
- Hypercholesterolaemia (total cholesterol ≥ 6.2 mmol/L
- Hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
- Current smoker
- Family history of coronary artery disease (first-degree relative <60 years)
- Prevalence of vascular disease
- Autonomic neuropathy
- Kidney disease
- Diagnosed pulmonary disease (e.g. chronic obstructive pulmonary disease, asthma, interstitial lung disease or cystic fibrosis)
- Blood borne disease or infection
- Osteoporosis
- Osteoarthritis
- Blood clotting disorders
- Food intolerances/allergies (these may not specifically exclude you- please talk to the investigator)
- Sensitivity or allergy to anaesthetic
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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<70 kg body mass
Cyclists or triathletes with a body mass of less than 70 kg
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120 minutes of cycling at 95% of lactate threshold ingesting 90 g/h of glucose
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>70 kg body mass
Cyclists or triathletes with a body mass of less than 70 kg
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120 minutes of cycling at 95% of lactate threshold ingesting 90 g/h of glucose
120 minutes of cycling at a power matched to participant in the <70 kg body mass group, ingesting 90 g/h of glucose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak exogenous carbohydrate oxidation rate (g/min)
Time Frame: 120 minute
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Peak exogenous carbohydrate oxidation rate (g/min)
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120 minute
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Total exogenous carbohydrate oxidation (g)
Time Frame: minutes 30-120 of exercise
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Sum of exogenous carbohydrate oxidation in g
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minutes 30-120 of exercise
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma lactate concentrations (mmol/L)
Time Frame: minutes 0-120 of exercise
|
Plasma lactate concentrations (mmol/L)
|
minutes 0-120 of exercise
|
|
Plasma glucose concentrations (mmol/L)
Time Frame: minutes 0-120 of exercise
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Plasma glucose concentrations (mmol/L)
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minutes 0-120 of exercise
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Plasma non-esterified fatty acid concentrations (mmol/L)
Time Frame: minutes 0-120 of exercise
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Plasma non-esterified fatty acid concentrations (mmol/L)
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minutes 0-120 of exercise
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Plasma insulin concentrations (pmol/L)
Time Frame: minutes 0-120 of exercise
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Plasma insulin concentrations (pmol/L)
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minutes 0-120 of exercise
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Dietary carbohydrate intake (grams/day)
Time Frame: 72-hour food diary in g/d
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Dietary carbohydrate intake (grams/day)
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72-hour food diary in g/d
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Dietary sugar intake (grams/day)
Time Frame: 72-hour food diary
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Dietary sugar intake (grams/day)
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72-hour food diary
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Dietary fibre intake (grams/day)
Time Frame: 72-hour food diary
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Dietary fibre intake (grams/day)
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72-hour food diary
|
|
Dietary fat intake (grams/day)
Time Frame: 72-hour food diary
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Dietary fat intake (grams/day)
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72-hour food diary
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Dietary protein intake (grams/day)
Time Frame: 72-hour food diary
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Dietary protein intake (grams/day)
|
72-hour food diary
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Dietary energy intake (kiloJoules/day)
Time Frame: 72-hour food diary
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Dietary energy intake (kiloJoules/day)
|
72-hour food diary
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|
Dietary energy intake (kilojoules/kilogram/day)
Time Frame: 72-hour food diary
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Dietary energy intake (kilojoules/kilogram/day)
|
72-hour food diary
|
|
Dietary carbohydrate intake (grams/kilogram/day)
Time Frame: 72-hour food diary
|
Dietary carbohydrate intake (grams/kilogram/day)
|
72-hour food diary
|
|
Dietary sugar intake (grams/kilogram/day)
Time Frame: 72-hour food diary
|
Dietary sugar intake (grams/kilogram/day)
|
72-hour food diary
|
|
Dietary fibre intake (grams/kilogram/day)
Time Frame: 72-hour food diary
|
Dietary fibre intake (grams/kilogram/day)
|
72-hour food diary
|
|
Dietary fat intake (grams/kilogram/day)
Time Frame: 72-hour food diary
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Dietary fat intake (grams/kilogram/day)
|
72-hour food diary
|
|
Dietary protein intake (grams/kilogram/day)
Time Frame: 72-hour food diary
|
Dietary protein intake (grams/kilogram/day)
|
72-hour food diary
|
|
Total exogenous carbohydrate oxidation (g/kgFFM)
Time Frame: minutes 30-120 of exercise i
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Sum of exogenous carbohydrate oxidation (g/kgFFM)
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minutes 30-120 of exercise i
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Whole-body carbohydrate oxidation rate (g)
Time Frame: minutes 30-120 of exercise
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Sum of whole-body carbohydrate oxidation (g)
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minutes 30-120 of exercise
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Whole-body carbohydrate oxidation rate (mg/kgFFM)
Time Frame: Sum of minutes 30-120 of exercise
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Sum of whole-body carbohydrate oxidation (mg/kgFFM)
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Sum of minutes 30-120 of exercise
|
|
Endogenous carbohydrate oxidation rate (g)
Time Frame: minutes 30-120 of exercise
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Sum of endogenous carbohydrate oxidation (g)
|
minutes 30-120 of exercise
|
|
Endogenous carbohydrate oxidation rate (mg/kgFFM)
Time Frame: minutes 30-120 of exercise
|
Sum of endogenous carbohydrate oxidation (mg/kgFFM)
|
minutes 30-120 of exercise
|
|
Whole-body fat oxidation rate (g)
Time Frame: minutes 30-120 of exercise
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Sum of whole-body fat oxidation (g)
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minutes 30-120 of exercise
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Whole-body fat oxidation rate (mg/kgFFM)
Time Frame: minutes 30-120 of exercise
|
Sum of whole-body fat oxidation (mg/kgFFM)
|
minutes 30-120 of exercise
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- 6632
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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