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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05330481
Other study ID # 6632
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date December 30, 2025

Study information

Verified date November 2023
Source University of Bath
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date December 30, 2025
Est. primary completion date August 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Moderate-intensity (relative) exercise with glucose ingestion
120 minutes of cycling at 95% of lactate threshold ingesting 90 g/h of glucose
Moderate-intensity (absolute) exercise with glucose ingestion
120 minutes of cycling at a power matched to participant in the <70 kg body mass group, ingesting 90 g/h of glucose

Locations

Country Name City State
United Kingdom Department for Health, University of Bath Bath

Sponsors (2)

Lead Sponsor Collaborator
University of Bath University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak exogenous carbohydrate oxidation rate (g/min) Peak exogenous carbohydrate oxidation rate (g/min) 120 minute
Primary Total exogenous carbohydrate oxidation (g) Sum of exogenous carbohydrate oxidation in g minutes 30-120 of exercise
Secondary Total exogenous carbohydrate oxidation (g/kgFFM) Sum of exogenous carbohydrate oxidation (g/kgFFM) minutes 30-120 of exercise i
Secondary Whole-body carbohydrate oxidation rate (g) Sum of whole-body carbohydrate oxidation (g) minutes 30-120 of exercise
Secondary Whole-body carbohydrate oxidation rate (mg/kgFFM) Sum of whole-body carbohydrate oxidation (mg/kgFFM) Sum of minutes 30-120 of exercise
Secondary Endogenous carbohydrate oxidation rate (g) Sum of endogenous carbohydrate oxidation (g) minutes 30-120 of exercise
Secondary Endogenous carbohydrate oxidation rate (mg/kgFFM) Sum of endogenous carbohydrate oxidation (mg/kgFFM) minutes 30-120 of exercise
Secondary Whole-body fat oxidation rate (g) Sum of whole-body fat oxidation (g) minutes 30-120 of exercise
Secondary Whole-body fat oxidation rate (mg/kgFFM) Sum of whole-body fat oxidation (mg/kgFFM) minutes 30-120 of exercise
Secondary Plasma lactate concentrations (mmol/L) Plasma lactate concentrations (mmol/L) minutes 0-120 of exercise
Secondary Plasma glucose concentrations (mmol/L) Plasma glucose concentrations (mmol/L) minutes 0-120 of exercise
Secondary Plasma non-esterified fatty acid concentrations (mmol/L) Plasma non-esterified fatty acid concentrations (mmol/L) minutes 0-120 of exercise
Secondary Plasma insulin concentrations (pmol/L) Plasma insulin concentrations (pmol/L) minutes 0-120 of exercise
Secondary Dietary carbohydrate intake (grams/day) Dietary carbohydrate intake (grams/day) 72-hour food diary in g/d
Secondary Dietary sugar intake (grams/day) Dietary sugar intake (grams/day) 72-hour food diary
Secondary Dietary fibre intake (grams/day) Dietary fibre intake (grams/day) 72-hour food diary
Secondary Dietary fat intake (grams/day) Dietary fat intake (grams/day) 72-hour food diary
Secondary Dietary protein intake (grams/day) Dietary protein intake (grams/day) 72-hour food diary
Secondary Dietary energy intake (kiloJoules/day) Dietary energy intake (kiloJoules/day) 72-hour food diary
Secondary Dietary energy intake (kilojoules/kilogram/day) Dietary energy intake (kilojoules/kilogram/day) 72-hour food diary
Secondary Dietary carbohydrate intake (grams/kilogram/day) Dietary carbohydrate intake (grams/kilogram/day) 72-hour food diary
Secondary Dietary sugar intake (grams/kilogram/day) Dietary sugar intake (grams/kilogram/day) 72-hour food diary
Secondary Dietary fibre intake (grams/kilogram/day) Dietary fibre intake (grams/kilogram/day) 72-hour food diary
Secondary Dietary fat intake (grams/kilogram/day) Dietary fat intake (grams/kilogram/day) 72-hour food diary
Secondary Dietary protein intake (grams/kilogram/day) Dietary protein intake (grams/kilogram/day) 72-hour food diary
See also
  Status Clinical Trial Phase
Completed NCT02160873 - Nighttime Feeding and Morning Endurance Performance N/A