NCT05330481

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.2 years

First QC Date

March 2, 2022

Last Update Submit

September 17, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Peak exogenous carbohydrate oxidation rate (g/min)

    Peak exogenous carbohydrate oxidation rate (g/min)

    120 minute

  • Total exogenous carbohydrate oxidation (g)

    Sum of exogenous carbohydrate oxidation in g

    minutes 30-120 of exercise

Secondary Outcomes (23)

  • Total exogenous carbohydrate oxidation (g/kgFFM)

    minutes 30-120 of exercise i

  • Whole-body carbohydrate oxidation rate (g)

    minutes 30-120 of exercise

  • Whole-body carbohydrate oxidation rate (mg/kgFFM)

    Sum of minutes 30-120 of exercise

  • Endogenous carbohydrate oxidation rate (g)

    minutes 30-120 of exercise

  • Endogenous carbohydrate oxidation rate (mg/kgFFM)

    minutes 30-120 of exercise

  • +18 more secondary outcomes

Study Arms (2)

<70 kg body mass

Cyclists or triathletes with a body mass of less than 70 kg

Other: Moderate-intensity (relative) exercise with glucose ingestion

>70 kg body mass

Cyclists or triathletes with a body mass of less than 70 kg

Other: Moderate-intensity (relative) exercise with glucose ingestionOther: Moderate-intensity (absolute) exercise with glucose ingestion

Interventions

120 minutes of cycling at 95% of lactate threshold ingesting 90 g/h of glucose

<70 kg body mass>70 kg body mass

120 minutes of cycling at a power matched to participant in the \<70 kg body mass group, ingesting 90 g/h of glucose

>70 kg body mass

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Trained cyclists or triathletes

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Location

Biospecimen

Plasma

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader (Associate Professor) in Human Physiology

Study Record Dates

First Submitted

March 2, 2022

First Posted

April 15, 2022

Study Start

March 1, 2022

Primary Completion

April 27, 2024

Study Completion

July 27, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations