Dietary Manipulation Clinical Trial
Official title:
The Effect of Dietary Macronutrient Manipulation and Glycogen Depleting Exercise on Substrate Oxidation at Rest and During Exercise
| 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 |
| Verified date | October 2018 |
| Source | University of Birmingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | School of Sport Exercise and Rehabilitation Sciences, University of Birmingham | Birmingham |
| Lead Sponsor | Collaborator |
|---|---|
| University of Birmingham | Lucozade Ribena Suntory |
United Kingdom,
| 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 |