- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05241730
Glycaemic Index and Substrate Metabolism (GI)
Influence of a Diet With Different Glycaemic Indices and Carbohydrate Content on Substrate Utilization, Energy Storage, and Performance-related Parameters in Endurance-trained Men
Substrate metabolism during exercise can be influenced by various nutritional regimes. The effectiveness of the different nutritional regimes, which differ in their carbohydrate content, will be investigated not only by functional tests but also the measurement of the mechanistic processes in the muscle will be explored.
Magnetic resonance (MR), better known as magnetic resonance imaging (MRI), has been widely used in clinical practice as a non-invasive imaging technique. Importantly, in addition to producing anatomical images, an MR scanner also offers the possibility to measure the concentrations of a number of metabolic products. This is done through a technique known as magnetic resonance spectroscopy (MRS).
This research project asks the following questions:
- Can a diet containing carbohydrates with a low glycemic index achieve the same adaptations in basic endurance/fat metabolism as a high fat, low carbohydrate (ketogenic) diet?
- Does a high-fat, low-carbohydrate diet, compared with a high-carbohydrate diet, prevent improvements in performance in the submaximal and maximal range?
- What is the effect of diets with different carbohydrate content and variable glycemic index on endurance performance in a half marathon and a time trial?
- How do the diets with different carbohydrate content and variable glycaemic index affect the energy and glycogen stores in the muscles?
In active recreational athletes, the objectives are: (1) to investigate the effects of different diets with variable carbohydrate content and glycaemic index on substrate metabolism, (2) to determine the effects of the different diets on energy stores using multinuclear dynamic magnetic resonance spectroscopy, and (3) to measure the effects of the different diets on endurance performance.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Vienna, Austria, 1070
- University of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male gender
- Age between 18 and 40 years
- Recreational active in leisure time (2-3x/week physical activity)
- Motivation for performance testing and structured training plan
- Interest in different diets
- no acute or chronic illnesses
Exclusion Criteria:
- Contraindications to physical exercise according to ACSM (American College of Sports Medicine) guidelines
- Age <18 or >40 years
- Taking medication that could influence the measurements or that is prohibited in training and/or competition according to the WADA (World Anti-Doping Agency) Code
- Competitive athlete with own training plan
- Experience with intervention diets
MRI-specific exclusion criteria:
- Claustrophobia
- Cardiac pacemaker
- cochlear implant
- subcutaneous injection system
- Stents, metal implants, braces, piercings, tattoos
- Body weight of more than 180 kg or BMI of more than 37 kg/m2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low GI
The subjects eat 55-60 E-% carbohydrates with ≥ 65 % from low glycaemic index carbohydrates per day, the other E-% are fats and proteins.
|
The training intervention will be a 10 week training plan for endurance runners.
The plan consists of five sessions per week (three basic endurance sessions and two interval sessions)
The subjects eat 55-60 E-% carbohydrates with ≥ 65 % from low glycaemic index carbohydrates per day, the other E-% are fats and proteins.
|
|
Active Comparator: High GI
The subjects eat 55-60 E-% carbohydrates with ≥ 65 % from high glycaemic index carbohydrates per day, the other E-% are fats and proteins.
|
The training intervention will be a 10 week training plan for endurance runners.
The plan consists of five sessions per week (three basic endurance sessions and two interval sessions)
The subjects eat 55-60 E-% carbohydrates with ≥ 65 % from high glycaemic index carbohydrates per day, the other E-% are fats and proteins.
|
|
Experimental: Low Carb High Fat
The subjects eat ≥ 65 E-% fats and a maximum of 50 g carbohydrates per day.
|
The training intervention will be a 10 week training plan for endurance runners.
The plan consists of five sessions per week (three basic endurance sessions and two interval sessions)
The subjects eat ≥ 65 E-% fats and a maximum of 50 g carbohydrates per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in peak oxygen consumption (measured in ml/min/kg)
Time Frame: Baseline - 10 weeks
|
VO2peak will be assessed during a graded exercise test on the treadmill.
|
Baseline - 10 weeks
|
|
changes in 5 km time trial (measured in mm:ss)
Time Frame: Baseline - 10 weeks
|
5 km time trial performance will be assessed during an all out 5 km run on a 400 m running track.
The time for completing the 5 km will be assessed.
|
Baseline - 10 weeks
|
|
changes in muscle glycogen content (measured in mmol/l muscle)
Time Frame: Baseline - 10 weeks
|
Changes in muscle glycogen will be assessed in a thigh muscle using a MR scan.
|
Baseline - 10 weeks
|
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changes in power at lactate turning point 1 (LTP1) and individual anaerobic threshold (IAS) (measured in km/h)
Time Frame: Baseline - 10 weeks
|
Changes in power at LTP1 and IAS will be assessed during a graded exercise test on a treadmill.
|
Baseline - 10 weeks
|
|
changes in AUC in lactate in the graded exercise test
Time Frame: Baseline - 10 weeks
|
Changes in AUS in lactate will be assessed during a graded exercise test on a treadmill.
|
Baseline - 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in fat free mass (measured in kg)
Time Frame: Baseline - 5 weeks - 10 weeks
|
Changes in fat free mass will be assessed using a bioelectrical impedance analysis.
|
Baseline - 5 weeks - 10 weeks
|
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changes in fat mass (measured in kg)
Time Frame: Baseline - 5 weeks - 10 weeks
|
Changes in fat mass will be assessed using a bioelectrical impedance analysis.
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Baseline - 5 weeks - 10 weeks
|
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changes in skeletal muscle mass (measured in kg)
Time Frame: Baseline - 5 weeks - 10 weeks
|
Changes in skeletal muscle mass will be assessed using a bioelectrical impedance analysis.
|
Baseline - 5 weeks - 10 weeks
|
|
changes in body water (measured in l)
Time Frame: Baseline - 5 weeks - 10 weeks
|
Changes in total and extracellular body water will be assessed using a bioelectrical impedance analysis.
|
Baseline - 5 weeks - 10 weeks
|
|
changes in body weight (measured in kg)
Time Frame: Baseline - 5 weeks - 10 weeks
|
Changes in body weight will be assessed using a bioelectrical impedance analysis.
|
Baseline - 5 weeks - 10 weeks
|
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changes in body mass index
Time Frame: Baseline - 5 weeks - 10 weeks
|
Changes in body mass index will be assessed using a bioelectrical impedance analysis.
The weight and the height will be used to calculate changes in BMI in kg/m^2.
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Baseline - 5 weeks - 10 weeks
|
|
completion time of a half marathon performance (measured in hh:mm:ss)
Time Frame: after 10 weeks
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The half marathon performance will be assessed during an official marathon race.
The time of completion of the half marathon will be assessed.
|
after 10 weeks
|
|
changes in cholesterin and cholesterin subunits (measured in mg/dl)
Time Frame: Baseline - 10 weeks
|
Changes in cholesterin and cholesterin subunits (LDL and HDL cholesterin) will be assessed with a routine blood count.
|
Baseline - 10 weeks
|
|
changes in rated perceived exhaustion (RPE) in 5 km time trial
Time Frame: Baseline - 10 weeks
|
The changes in RPE will be assessed during the 5 km time trial on a running track.
The RPE scale ranges from 6 to 20, where 20 means "really, really exhausting".
|
Baseline - 10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2105/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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