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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02605291
Other study ID # ERN_15-0963
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date June 2017

Study information

Verified date October 2018
Source University of Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the effect of dietary macronutrient manipulation on glycogen (stored carbohydrate) levels in the muscle and substrate oxidation during exercise. The investigators will investigate the hypothesis that manipulating the macronutrient content of the diet will alter the levels of glycogen in the muscle and, in turn, substrate oxidation during exercise.


Description:

One way to help reduce body fat is to expend more energy from the oxidation of fat as a fuel. Exercise is one way to increase fat oxidation. The extent to which exercise facilitates the use of fat as a fuel may be influenced by an individual's dietary intake.

This study aims to establish the effect of dietary macronutrient manipulation on muscle glycogen levels and substrate oxidation during exercise. Participants will undertake three separate trial periods. During each trial period participants will consume a diet containing different macronutrient compositions. For each of the trials the investigators will assess how the macronutrient composition of the diet affects muscle glycogen level and substrate oxidation during exercise.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Good general health

- Non-smoking - currently and for the past 5 years

- Fitness - V?O2max 40-60 ml/kg/min

- Body mass index (20-25 kg/m2)

Exclusion Criteria:

- Known or suspected intolerance to the dietary interventions or their stated ingredients.

- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.

- Previous participation in this study.

- Recent history (within the last year) of alcohol or other substance abuse.

- An employee of the sponsor or the study site or members of their immediate family.

- Abnormal / extreme habitual dietary practice / intake

- Recent (=3 months) dietary practice that may be deemed as low and/or high in macronutrients will be excluded.

- The taking of any prescribed medication

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Diet with a different macronutrient content A
A diet with altered macronutrient content will be provided to participants on days 4-6 of experimental arm 1.
Diet with a different macronutrient content B
A diet with a different macronutrient content compared to arm 1 will be provided to participants on days 4-6 of experimental arm 2.
Diet with a different macronutrient content C
A diet with a different macronutrient content compared to arms 1 and 2 will be provided to participants on days 4-6 of experimental arm 3.
Interval treadmill running exercise
Participants will perform interval treadmill running exercise on days 4 and 5 of all experimental arms.
Steady state treadmill running exercise
Participants will perform steady state treadmill running exercise on day 7 of all experimental arms.

Locations

Country Name City State
United Kingdom School of Sport Exercise and Rehabilitation Sciences, University of Birmingham Birmingham

Sponsors (2)

Lead Sponsor Collaborator
University of Birmingham Lucozade Ribena Suntory

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle glycogen concentration after dietary macronutrient manipulation Muscle glycogen concentration will be measured after the dietary macronutrient manipulation intervention. Day 7 of all experimental arms
Secondary Rate of fat oxidation at rest (g/min) Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) at rest will be measured using indirect calorimetry to calculate the rate of fat oxidation at rest (g/min). For 20 min on Day 7 of all experimental arms
Secondary Rate of fat oxidation during exercise (g/min) Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) during exercise will be measured using indirect calorimetry to calculate the rate of fat oxidation during exercise (g/min). During 60 min of exercise on day 7 of all experimental arms
Secondary Rate of carbohydrate oxidation at rest (g/min) Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) at rest will be measured using indirect calorimetry to calculate the rate of carbohydrate oxidation at rest (g/min). For 20 min on Day 7 of all experimental arms
Secondary Rate of carbohydrate oxidation during exercise (g/min) Whole body oxygen consumption (VO2, L/min) and carbon dioxide production (VCO2, L/min) during exercise will be measured using indirect calorimetry to calculate the rate of carbohydrate oxidation during exercise (g/min). During 60 min of exercise on day 7 of all experimental arms
Secondary Blood glucose concentration Blood glucose concentration will be assessed in blood samples taken during exercise. At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms.
Secondary Blood insulin concentration Blood insulin concentration will be assessed in blood samples taken during exercise. At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
Secondary Blood fatty acid concentration Blood fatty acid concentration will be assessed in blood samples taken during exercise. At 0, 20, 40 and 60min into exercise on day 7 of all experimental arms
Secondary Change in intramuscular triglyceride (IMTG) content after exercise IMTG utilisation during exercise (or change in IMTG content pre-post exercise) will be measured by comparing the IMTG content before and after exercise. IMTG content measured just before and immediately after 60min of exercise on Day 7 of all experimental arms