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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03731065
Other study ID # MSES 17/18-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2018
Est. completion date November 30, 2019

Study information

Verified date December 2019
Source University of Bath
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to characterise exogenous carbohydrate oxidation rates during exercise, when ingesting glucose (polymers) only, compared to glucose-fructose mixtures, and glucose-fructose mixtures ingested in hydrogel form.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date November 30, 2019
Est. primary completion date October 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Maximal oxygen consumption > 50 ml.kg-1.min-1

- > 1 year training in endurance running or triathlon

- No current injury or injury within the last three months

- No history of cardiac or metabolic disease such as coronary heart disease or diabetes

- No current or history of gastrointestinal issues

- Successful completion of the physical activity readiness questionnaire (PAR-Q)

Exclusion Criteria:

- Female

- Untrained in endurance running

- Current injury or injury within the past three months

- History of cardiac or metabolic disease such as coronary heart disease or diabetes

- History of or current gastrointestinal issues such as irritable bowel syndrome

- Unable to replicate diet and training for 3 and 5 days respectively prior to each experimental visit.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Fructose-maltodextrin
Fructose plus maltodextrin in a ratio of 1:1.4, diluted in water to produce a 16% carbohydrate solution.
Fructose-maltodextrin hydrogel
Fructose plus maltodextrin in a ratio of 1:1.4, encapsulated in an alginate-pectin hydrogel diluted in water to produce a 16% carbohydrate solution.
Glucose-maltodextrin
Glucose plus maltodextrin in a ratio of 1:1.4, diluted in water to produce a 16% carbohydrate solution.

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 Peak exogenous carbohydrate oxidation rate during 120 min of treadmill running. Measured using isotope ratio mass spectrometry and reported in grams per minute 120 minutes
Secondary Total carbohydrate oxidation Total carbohydrate oxidation during 120 min of treadmill running. Measured using indirect calorimetry and reported in grams. 120 minutes
Secondary Ratings of gastrointestinal discomfort Subjective ratings of gastrointestinal discomfort during 120 min of treadmill running. Measured using a 9-item questionnaire on a scale of 1 to 7, where 1 = No discomfort at all and 7 = very severe discomfort.
Items: Stomach; Heartburn; Acid reflux; Nausea; Rumbling; Bloated; Burping; Passing gas; Bowel movement.
120 minutes
Secondary Total fat oxidation Total fat oxidation during 120 min of treadmill running. Measured using indirect calorimetry and reported in grams. 120 minutes
Secondary Plasma insulin concentrations Plasma insulin concentrations during 120 min of treadmill running. Measured using enzyme-linked immunosorbent assay and reported in pmol/L. 120 minutes
Secondary Plasma glucose concentrations Plasma lactate concentrations during 120 min of treadmill running. Measured using colourimetric assay and reported in mmol/L. 120 minutes
Secondary Plasma lactate concentrations Plasma lactate concentrations during 120 min of treadmill running. Measured using colourimetric assay and reported in mmol/L. 120 minutes
Secondary Plasma non-esterified fatty acid concentrations Plasma insulin concentrations during 120 min of treadmill running. Measured using colourimetric assay and reported in umol/L. 120 minutes
Secondary Ratings of perceived exertion Subjective ratings of perceived exertion using the Borg scale (1982) during 120 min of treadmill running. Measured on a scale of 6 to 20, where 6 = no exertion at all, and 20 = maximal exertion. 120 minutes
Secondary Heart rate Heart rate during treadmill running measured by telemetry and reported in beats per minute. 120 minutes
Secondary Rate of oxygen consumption Rate of oxygen consumption during 120 min of treadmill running. Measured using indirect calorimetry and reported in litres per minute. 120 minutes
Secondary Rate of carbon dioxide production Rate of carbon dioxide production during 120 min of treadmill running. Measured using indirect calorimetry and reported in litres per minute. 120 minutes
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