Substrate Metabolism During ExerciseGINCT05241730
Glycaemic Index and Substrate Metabolism
A study testing Training intervention, High Glycaemic Index and LCHF in people with Substrate Metabolism During Exercise, run by University of Vienna at 1 site in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substrate Metabolism During Exercise
- What is being tested?
- Training intervention, High Glycaemic Index and LCHF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteAustria
- Study dates
- 10 Jan 2022to 23 Apr 2023
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
- Conditions
- Substrate Metabolism During Exercise
- Being tested
- Training intervention, High Glycaemic Index, LCHF, Low Glycaemic Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training interventionOther
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)
High Glycaemic IndexOther
The subjects eat 55-60 E-% carbohydrates with ≥ 65 % from high glycaemic index carbohydrates per day, the other E-% are fats and proteins.
LCHFOther
The subjects eat ≥ 65 E-% fats and a maximum of 50 g carbohydrates per day.
Low Glycaemic IndexOther
The subjects eat 55-60 E-% carbohydrates with ≥ 65 % from low glycaemic index carbohydrates per day, the other E-% are fats and proteins.
| Study group | Role | What they receive |
|---|---|---|
| Low GI | Experimental | The subjects eat 55-60 E-% carbohydrates with ≥ 65 % from low glycaemic index carbohydrates per day, the other E-% are fats and proteins. Receives: Other: Training intervention; Other: Low Glycaemic Index |
| High GI | Active comparator | The subjects eat 55-60 E-% carbohydrates with ≥ 65 % from high glycaemic index carbohydrates per day, the other E-% are fats and proteins. Receives: Other: Training intervention; Other: High Glycaemic Index |
| Low Carb High Fat | Experimental | The subjects eat ≥ 65 E-% fats and a maximum of 50 g carbohydrates per day. Receives: Other: Training intervention; Other: LCHF |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in peak oxygen consumption (measured in ml/min/kg)
VO2peak will be assessed during a graded exercise test on the treadmill.
Measured: Baseline - 10 weeks
changes in 5 km time trial (measured in mm:ss)
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.
Measured: Baseline - 10 weeks
changes in muscle glycogen content (measured in mmol/l muscle)
Changes in muscle glycogen will be assessed in a thigh muscle using a MR scan.
Measured: Baseline - 10 weeks
changes in power at lactate turning point 1 (LTP1) and individual anaerobic threshold (IAS) (measured in km/h)
Changes in power at LTP1 and IAS will be assessed during a graded exercise test on a treadmill.
Measured: Baseline - 10 weeks
changes in AUC in lactate in the graded exercise test
Changes in AUS in lactate will be assessed during a graded exercise test on a treadmill.
Measured: Baseline - 10 weeks
Secondary outcomes (9)
changes in fat free mass (measured in kg)
Changes in fat free mass will be assessed using a bioelectrical impedance analysis.
Measured: Baseline - 5 weeks - 10 weeks
changes in fat mass (measured in kg)
Changes in fat mass will be assessed using a bioelectrical impedance analysis.
Measured: Baseline - 5 weeks - 10 weeks
changes in skeletal muscle mass (measured in kg)
Changes in skeletal muscle mass will be assessed using a bioelectrical impedance analysis.
Measured: Baseline - 5 weeks - 10 weeks
changes in body water (measured in l)
Changes in total and extracellular body water will be assessed using a bioelectrical impedance analysis.
Measured: Baseline - 5 weeks - 10 weeks
changes in body weight (measured in kg)
Changes in body weight will be assessed using a bioelectrical impedance analysis.
Measured: Baseline - 5 weeks - 10 weeks
changes in body mass index
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.
Measured: Baseline - 5 weeks - 10 weeks
completion time of a half marathon performance (measured in hh:mm:ss)
The half marathon performance will be assessed during an official marathon race. The time of completion of the half marathon will be assessed.
Measured: after 10 weeks
changes in cholesterin and cholesterin subunits (measured in mg/dl)
Changes in cholesterin and cholesterin subunits (LDL and HDL cholesterin) will be assessed with a routine blood count.
Measured: Baseline - 10 weeks
changes in rated perceived exhaustion (RPE) in 5 km time trial
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".
Measured: Baseline - 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start10 Jan 2022
- Primary completion23 Apr 2023
- Study completion23 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substrate Metabolism During ExerciseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Principal investigator, Daniel König, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241730
- Sponsor's protocol ID
- 2105/2021
- Acronym
- GI
- Status last verified
- Nov 2023
- First submitted
- 25 Jan 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moitzi AM, Krssak M, Klepochova R, Triska C, Csapo R, Konig D. Effects of a 10-Week Exercise and Nutritional Intervention with Variable Dietary Carbohydrates and Glycaemic Indices on Substrate Metabolism, Glycogen Storage, and Endurance Performance in Men: A Randomized Controlled Trial. Sports Med Open. 2024 Apr 10;10(1):36. doi: 10.1186/s40798-024-00705-9.
PubMed 38600291
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Diet With Different Glycaemic Indices and Carbohydrate Content on Substrate Utilization, Energy Storage, and Performance-related Parameters in Endurance-trained Men
- ClinicalTrials.gov ID
- NCT05241730
- Acronym / sponsor ID
- GI / 2105/2021
- Conditions
- Substrate Metabolism During Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 23 Apr 2023 (actual)
- Study completion
- 23 Apr 2023 (actual)
- First posted
- 16 Feb 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low GI | Experimental | Other: Training intervention, Other: Low Glycaemic IndexThe subjects eat 55-60 E-% carbohydrates with ≥ 65 % from low glycaemic index carbohydrates per day, the other E-% are fats and proteins. |
| High GI | Active comparator | Other: Training intervention, Other: High Glycaemic IndexThe subjects eat 55-60 E-% carbohydrates with ≥ 65 % from high glycaemic index carbohydrates per day, the other E-% are fats and proteins. |
| Low Carb High Fat | Experimental | Other: Training intervention, Other: LCHFThe subjects eat ≥ 65 E-% fats and a maximum of 50 g carbohydrates per day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Training interventionThe 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) | Other | High GI, Low Carb High Fat, Low GI |
| High Glycaemic IndexThe subjects eat 55-60 E-% carbohydrates with ≥ 65 % from high glycaemic index carbohydrates per day, the other E-% are fats and proteins. | Other | High GI |
| LCHFThe subjects eat ≥ 65 E-% fats and a maximum of 50 g carbohydrates per day. | Other | Low Carb High Fat |
| Low Glycaemic IndexThe subjects eat 55-60 E-% carbohydrates with ≥ 65 % from low glycaemic index carbohydrates per day, the other E-% are fats and proteins. | Other | Low GI |
Primary outcome
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.
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.
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.
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.
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.
9 secondary outcomes
changes in fat free mass (measured in kg)
Time frame: Baseline - 5 weeks - 10 weeks
changes in fat mass (measured in kg)
Time frame: Baseline - 5 weeks - 10 weeks
changes in skeletal muscle mass (measured in kg)
Time frame: Baseline - 5 weeks - 10 weeks
changes in body water (measured in l)
Time frame: Baseline - 5 weeks - 10 weeks
changes in body weight (measured in kg)
Time frame: Baseline - 5 weeks - 10 weeks
changes in body mass index
Time frame: Baseline - 5 weeks - 10 weeks
completion time of a half marathon performance (measured in hh:mm:ss)
Time frame: after 10 weeks
changes in cholesterin and cholesterin subunits (measured in mg/dl)
Time frame: Baseline - 10 weeks
changes in rated perceived exhaustion (RPE) in 5 km time trial
Time frame: Baseline - 10 weeks
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 27 Nov 2023.
- Derived from this study: PubMed 38600291Moitzi AM, Krssak M, Klepochova R, Triska C, Csapo R, Konig D. Effects of a 10-Week Exercise and Nutritional Intervention with Variable Dietary Carbohydrates and Glycaemic Indices on Substrate Metabolism, Glycogen Storage, and Endurance Performance in Men: A Randomized Controlled Trial. Sports Med Open. 2024 Apr 10;10(1):36. doi: 10.1186/s40798-024-00705-9.
- Individual participant dataSharing planned: No
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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?
A study testing Training intervention, High Glycaemic Index and LCHF in people with Substrate Metabolism During Exercise, run by University of Vienna at 1 site in Austria.
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 6 inclusion and 12 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 27 Nov 2023. 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 Austria. 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?
changes in peak oxygen consumption (measured in ml/min/kg) (time frame: Baseline - 10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05241730, which also lists 1 linked publication.
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 27 Nov 2023.