Exercise MetabolismNCT05330481
Body Weight and Carb Metabolism
An observational study of Exercise Metabolism, run by University of Bath at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Metabolism
- What is being tested?
- Moderate-intensity (relative) exercise with glucose ingestion and Moderate-intensity (absolute) exercise with glucose ingestion
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2022to 27 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Trained cyclists or triathletes
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, BA2 7AY
About this study
Official title: 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.
- Conditions
- Exercise Metabolism
- Being tested
- Moderate-intensity (relative) exercise with glucose ingestion, Moderate-intensity (absolute) exercise with glucose ingestion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity (relative) exercise with glucose ingestionOther
120 minutes of cycling at 95% of lactate threshold ingesting 90 g/h of glucose
Moderate-intensity (absolute) exercise with glucose ingestionOther
120 minutes of cycling at a power matched to participant in the <70 kg body mass group, ingesting 90 g/h of glucose
| Study group | Role | What they receive |
|---|---|---|
| <70 kg body mass | Cyclists or triathletes with a body mass of less than 70 kg Receives: Other: Moderate-intensity (relative) exercise with glucose ingestion | |
| >70 kg body mass | Cyclists or triathletes with a body mass of less than 70 kg Receives: Other: Moderate-intensity (relative) exercise with glucose ingestion; Other: Moderate-intensity (absolute) exercise with glucose ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak exogenous carbohydrate oxidation rate (g/min)
Peak exogenous carbohydrate oxidation rate (g/min)
Measured: 120 minute
Total exogenous carbohydrate oxidation (g)
Sum of exogenous carbohydrate oxidation in g
Measured: minutes 30-120 of exercise
Secondary outcomes (23)
Total exogenous carbohydrate oxidation (g/kgFFM)
Sum of exogenous carbohydrate oxidation (g/kgFFM)
Measured: minutes 30-120 of exercise i
Whole-body carbohydrate oxidation rate (g)
Sum of whole-body carbohydrate oxidation (g)
Measured: minutes 30-120 of exercise
Whole-body carbohydrate oxidation rate (mg/kgFFM)
Sum of whole-body carbohydrate oxidation (mg/kgFFM)
Measured: Sum of minutes 30-120 of exercise
Endogenous carbohydrate oxidation rate (g)
Sum of endogenous carbohydrate oxidation (g)
Measured: minutes 30-120 of exercise
Endogenous carbohydrate oxidation rate (mg/kgFFM)
Sum of endogenous carbohydrate oxidation (mg/kgFFM)
Measured: minutes 30-120 of exercise
Whole-body fat oxidation rate (g)
Sum of whole-body fat oxidation (g)
Measured: minutes 30-120 of exercise
Whole-body fat oxidation rate (mg/kgFFM)
Sum of whole-body fat oxidation (mg/kgFFM)
Measured: minutes 30-120 of exercise
Plasma lactate concentrations (mmol/L)
Plasma lactate concentrations (mmol/L)
Measured: minutes 0-120 of exercise
Plasma glucose concentrations (mmol/L)
Plasma glucose concentrations (mmol/L)
Measured: minutes 0-120 of exercise
Plasma non-esterified fatty acid concentrations (mmol/L)
Plasma non-esterified fatty acid concentrations (mmol/L)
Measured: minutes 0-120 of exercise
Plasma insulin concentrations (pmol/L)
Plasma insulin concentrations (pmol/L)
Measured: minutes 0-120 of exercise
Dietary carbohydrate intake (grams/day)
Dietary carbohydrate intake (grams/day)
Measured: 72-hour food diary in g/d
Dietary sugar intake (grams/day)
Dietary sugar intake (grams/day)
Measured: 72-hour food diary
Dietary fibre intake (grams/day)
Dietary fibre intake (grams/day)
Measured: 72-hour food diary
Dietary fat intake (grams/day)
Dietary fat intake (grams/day)
Measured: 72-hour food diary
Dietary protein intake (grams/day)
Dietary protein intake (grams/day)
Measured: 72-hour food diary
Dietary energy intake (kiloJoules/day)
Dietary energy intake (kiloJoules/day)
Measured: 72-hour food diary
Dietary energy intake (kilojoules/kilogram/day)
Dietary energy intake (kilojoules/kilogram/day)
Measured: 72-hour food diary
Dietary carbohydrate intake (grams/kilogram/day)
Dietary carbohydrate intake (grams/kilogram/day)
Measured: 72-hour food diary
Dietary sugar intake (grams/kilogram/day)
Dietary sugar intake (grams/kilogram/day)
Measured: 72-hour food diary
Dietary fibre intake (grams/kilogram/day)
Dietary fibre intake (grams/kilogram/day)
Measured: 72-hour food diary
Dietary fat intake (grams/kilogram/day)
Dietary fat intake (grams/kilogram/day)
Measured: 72-hour food diary
Dietary protein intake (grams/kilogram/day)
Dietary protein intake (grams/kilogram/day)
Measured: 72-hour food diary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Mar 2022
- Primary completion27 Apr 2024
- Study completion27 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330481
- Sponsor's protocol ID
- 6632
- Status last verified
- Sep 2024
- First submitted
- 2 Mar 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Body Mass in Exogenous Carbohydrate Oxidation Rates During Exercise
- ClinicalTrials.gov ID
- NCT05330481
- Acronym / sponsor ID
- 6632
- Conditions
- Exercise Metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 27 Apr 2024 (actual)
- Study completion
- 27 Jul 2024 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| <70 kg body mass | – | Other: Moderate-intensity (relative) exercise with glucose ingestionCyclists or triathletes with a body mass of less than 70 kg |
| >70 kg body mass | – | Other: Moderate-intensity (relative) exercise with glucose ingestion, Other: Moderate-intensity (absolute) exercise with glucose ingestionCyclists or triathletes with a body mass of less than 70 kg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Trained cyclists or triathletes
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-intensity (relative) exercise with glucose ingestion120 minutes of cycling at 95% of lactate threshold ingesting 90 g/h of glucose | Other | <70 kg body mass, >70 kg body mass |
| Moderate-intensity (absolute) exercise with glucose ingestion120 minutes of cycling at a power matched to participant in the <70 kg body mass group, ingesting 90 g/h of glucose | Other | >70 kg body mass |
Primary outcome
Peak exogenous carbohydrate oxidation rate (g/min)
Time frame: 120 minute
Peak exogenous carbohydrate oxidation rate (g/min)
Total exogenous carbohydrate oxidation (g)
Time frame: minutes 30-120 of exercise
Sum of exogenous carbohydrate oxidation in g
23 secondary outcomes
Total exogenous carbohydrate oxidation (g/kgFFM)
Time frame: minutes 30-120 of exercise i
Whole-body carbohydrate oxidation rate (g)
Time frame: minutes 30-120 of exercise
Whole-body carbohydrate oxidation rate (mg/kgFFM)
Time frame: Sum of minutes 30-120 of exercise
Endogenous carbohydrate oxidation rate (g)
Time frame: minutes 30-120 of exercise
Endogenous carbohydrate oxidation rate (mg/kgFFM)
Time frame: minutes 30-120 of exercise
Whole-body fat oxidation rate (g)
Time frame: minutes 30-120 of exercise
Whole-body fat oxidation rate (mg/kgFFM)
Time frame: minutes 30-120 of exercise
Plasma lactate concentrations (mmol/L)
Time frame: minutes 0-120 of exercise
Plasma glucose concentrations (mmol/L)
Time frame: minutes 0-120 of exercise
Plasma non-esterified fatty acid concentrations (mmol/L)
Time frame: minutes 0-120 of exercise
Plasma insulin concentrations (pmol/L)
Time frame: minutes 0-120 of exercise
Dietary carbohydrate intake (grams/day)
Time frame: 72-hour food diary in g/d
Dietary sugar intake (grams/day)
Time frame: 72-hour food diary
Dietary fibre intake (grams/day)
Time frame: 72-hour food diary
Dietary fat intake (grams/day)
Time frame: 72-hour food diary
Dietary protein intake (grams/day)
Time frame: 72-hour food diary
Dietary energy intake (kiloJoules/day)
Time frame: 72-hour food diary
Dietary energy intake (kilojoules/kilogram/day)
Time frame: 72-hour food diary
Dietary carbohydrate intake (grams/kilogram/day)
Time frame: 72-hour food diary
Dietary sugar intake (grams/kilogram/day)
Time frame: 72-hour food diary
Dietary fibre intake (grams/kilogram/day)
Time frame: 72-hour food diary
Dietary fat intake (grams/kilogram/day)
Time frame: 72-hour food diary
Dietary protein intake (grams/kilogram/day)
Time frame: 72-hour food diary
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Metabolism, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak exogenous carbohydrate oxidation rate (g/min) (time frame: 120 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.