Diet, HealthyPROPERNCT05426447
Protein and Performance (PROPER) in Endurance Athletes
A study testing Dietary intervention of reduced protein intake and Dietary intervention of normal protein intake in people with Diet, Healthy and Protein Deficiency, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The present study is a parallel group design with randomised allocation to either a 1) reduced protein diet (RP) or a 2) normal protein diet (NP). The two groups will be pair-matched based on habitual dietary protein intake, endurance training, endurance performance, and sex. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Protein Deficiency
- What is being tested?
- Dietary intervention of reduced protein intake and Dietary intervention of normal protein intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Feb 2021to 31 Dec 2025
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Endurance athlete
- Exercising at least 10hrs per week
- Habitual dietary protein intake ~2g/kg body mass
- BMI<25
Who cannot join
- Food allergies that exclude the controlled diet
- Inconsistent endurance training load
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduced Dietary Protein, Performance and Health
The present study is a parallel group design with randomised allocation to either a 1) reduced protein diet (RP) or a 2) normal protein diet (NP). The two groups will be pair-matched based on habitual dietary protein intake, endurance training, endurance performance, and sex.
The aim of the study is to investigate the effects of reducing dietary protein (~1g protein/kg body mass) compared to an eucaloric normal protein diet (~2g protein/kg body mass) for 6 weeks in well-trained endurance athletes on endurance performance, body composition, skeletal muscle protein synthesis, and health-related outcomes.
The hypothesis is that endurance performance will maintain or even be improved in well-trained endurance athletes after a 6-week dietary intervention of an eucaloric, protein reduced diet compared to a normal protein rich diet.
Read the detailed description
Design: The present study will include two phases: a 3-week run-in period, and a 6-week intervention of controlled diets containing either a reduced dietary protein (RP) or normal (habitual) protein (NP). The run-in period serves as a period for obtaining general activity data and habitual dietary and training habits in order to match the groups before entering the dietary intervention period.
Subjects and dietary goals: The study is aiming at including 20 male endurance athletes exercising ~15hrs+/week. The 20 males will be pair-matched based on habitual endurance training, habitual dietary protein intake, and endurance performance, and allocated in a randomised order to: 1) a reduced-protein diet (RP) or 2) a normal-protein diet (NP).
3-weeks run-in period: After a minimum of 7 days after written consent has been obtained, the run-in period will begin. Habitual endurance training volumes will be registered in an online platform (TrainingPeaks) and daily activity level will be monitored using an accelerometer (SENS) throughout the run-in and diet intervention period. "Heavy water" (D2O) will be ingested in a large bolus (3.5ml/kg LBM) upon beginning of the run-in period and plasma enrichments will be maintained throughout the study period by ingesting small daily boluses. This serves to determine skeletal muscle protein synthesis throughout the study.
6-weeks dietary intervention: The diets will be eucaloric and the estimated energy percentages for macronutrients will be as follows: RP - Protein ~7E%, Carbohydrate ~63E%, Fat ~29E%. NP - Protein ~16E%, Carbohydrate ~53E%, Fat ~30E%. Weekly urine and faeces samples will be collected during the run-in period and dietary intervention and the controlled diets will be supplied weekly for the participants.
Testing: Extensive endurance performance and metabolic testing will be performed prior to-, and during the intervention on weeks -1, 0 (Pre), 3 (Mid), and 6 (Post). The tests include: Body composition by DXA-scanning, resting metabolic rate by online respirometry using a Vyntus (Jaeger, PCX), venous blood-, and skeletal muscle biopsy sampling from m. Vastus Lateralis, a standardised breakfasts, endurance cycling on an electro-magnetically braked bike (Lode Excalibur) or running on a motorised treadmill (Woodway), and haemoglobin mass measuring using a modified version of the CO-rebreathing method.
The body mass will be kept unchanged during the 6-weeks dietary intervention.
- Conditions
- Diet, Healthy, Protein Deficiency
- Being tested
- Dietary intervention of reduced protein intake, Dietary intervention of normal protein intake
- Keywords
- Diet intervention, Endurance athletes, Endurance performance, Skeletal muscle protein synthesis, Protein intake, Health markers, Microbiome
- Medical subject headings
- Protein Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention of reduced protein intakeOther
6-wk dietary intervention of reduced protein intake
Dietary intervention of normal protein intakeOther
6-wk dietary intervention of normal protein intake
| Study group | Role | What they receive |
|---|---|---|
| Reduced protein diet | Experimental | A 6-week eucaloric dietary intervention of reduced protein intake (~1g protein/kg body mass). The diet will, hence, contain ~7E% protein, ~63E% carbohydrate, and ~29E% fat.
Participants are free-living and receive all food pre-packed from the study kitchen. The energy provision will be set to match energy balance. Receives: Other: Dietary intervention of reduced protein intake |
| Normal protein diet | Active comparator | A 6-week eucaloric dietary intervention of normal protein intake (~2g protein/kg body mass). The diet will, hence, contain ~16E% protein, ~53E% carbohydrate, and ~30E% fat.
Participants are free-living and receive all food pre-packed from the study kitchen. The energy provision will be set to match energy balance. Receives: Other: Dietary intervention of normal protein intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance performance on a bike
Endurance performance defined as maximal aerobic power (Wmax) during incremental test to exhaustion on a bike measured as 1-minute mean power output (W)
Measured: From Pre (week0) to post (week6)
Microbiome
Diversity of bacterial strains in gut microbiome measured in feces samples
Measured: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Secondary outcomes (39)
Resting metabolic rate
Measured in an over-night fasted state via indirect calorimetry expressed in MJ/day
Measured: Pre (week0) to mid (week3)
Resting metabolic rate
Measured in an over-night fasted state via indirect calorimetry expressed in MJ/day
Measured: Pre (week0) to Post (week6)
Lean body mass
Measured by dual-energy x-ray (DXA)-scanningg expressed in kg
Measured: Run-in (week-3) to Pre (week0)
Lean body mass
Measured by dual-energy x-ray (DXA)-scanning expressed in kg
Measured: Pre (week0) to Post (week6)
Total fat mass
Measured by dual-energy x-ray (DXA)-scanning expressed in kg
Measured: Pre (week0) to Post (week6)
Total fat mass
Measured by dual-energy x-ray (DXA)-scanning expressed in kg
Measured: Pre (week0) to mid (week3)
Total fat mass
Measured by dual-energy x-ray (DXA)-scanning expressed in kg
Measured: Run-in (week-3) to Pre (week0)
Power output at 4mmol/L blood lactate
Alterations in Power output at 4mmol/L blood lactate in response to diet
Measured: Pre (week0) to mid (week3)
Power output at 4mmol/L blood lactate
Alterations in Power output at 4mmol/L blood lactate in response to diet
Measured: Pre (week0) to Post (week6)
Fractional utilisation of maximal oxygen uptake at 4mmol/L blood lactate
Alterations in Fractional utilisation of maximal oxygen uptake at 4mmol/L blood lactate in response to diet
Measured: Pre (week0) to mid (week3)
Fractional utilisation of maximal oxygen uptake at 4mmol/L blood lactate
Alterations in Fractional utilisation of maximal oxygen uptake at 4mmol/L blood lactate in response to diet
Measured: Pre (week0) to Post (week6)
Maximal oxygen uptake VO2peak
Alterations in Maximal oxygen uptake VO2peak measured by an online VO2 apparatus
Measured: Pre (week0) to mid (week3)
Maximal oxygen uptake VO2peak
Alterations in Maximal oxygen uptake VO2peak measured by an online VO2 apparatus
Measured: Pre (week0) to Post (week6)
Peak power output on a 10-seconds sprint
Alterations in peak power output on a 10-seconds sprint in response to diet
Measured: Pre (week0) to mid (week3)
Peak power output on a 10-seconds sprint
Alterations in peak power output on a 10-seconds sprint in response to diet
Measured: Pre (week0) to Post (week6)
Mean power output on a 10-seconds sprint
Alterations in mean power output on a 10-seconds sprint in response to diet
Measured: Pre (week0) to mid (week3)
Mean power output on a 10-seconds sprint
Alterations in mean power output on a 10-seconds sprint in response to diet
Measured: Pre (week0) to Post (week6)
Gross efficiency on a bike
Gross efficiency expressed as % of external power compared to internal (metabolic) power
Measured: Pre (week0) to mid (week3)
Gross work efficiency on a bike
Gross efficiency expressed as % of external power compared to internal (metabolic) power
Measured: Pre (week0) to Post (week6)
15-minute time-trial power output on a bike
Alterations in 15-minute time-trial mean power output
Measured: Pre (week0) to mid (week3)
15-minute time-trial power output on a bike
Alterations in 15-minute time-trial mean power output
Measured: Pre (week0) to Post (week6)
Fractional utilisation of maximal oxygen uptake during 15-minute time-trial
Alterations in Fractional utilisation of maximal oxygen uptake during 15-minute time-trial
Measured: Pre (week0) to mid (week3)
Fractional utilisation of maximal oxygen uptake during 15-minute time-trial
Alterations in Fractional utilisation of maximal oxygen uptake during 15-minute time-trial
Measured: Pre (week0) to Post (week6)
Respiratory exchange ratio
respiratory exchange ratio (RER) during rest and exercise using indirect calorimetry
Measured: Pre (week0) to Post (week6)
Respiratory exchange ratio
respiratory exchange ratio (RER) during rest and exercise using indirect calorimetry
Measured: Pre (week0) to Mid (week3)
Training load
Training load as quantified by Edward's Training Impulse based on heart rate zones
Measured: Run-in (week-3) vs dietary intervention (week0 to week6)
Energy intake
Habitual energy intake registered by food diaries expressed in Mega Joules
Measured: Run-in (week-3) vs dietary intervention (week0 to week6)
Energy expenditure
Energy expenditure is measured by combining resting metabolic rate and daily activity recording from accelerometer data and heart rate monitor
Measured: Run-in (week-3) vs dietary intervention (week0 to week6)
Blood lactate concentration
Glucose lactate measured in fasted state on an ABL800
Measured: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Blood glucose concentration
Glucose concentration measured in fasted state on an ABL800
Measured: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Blood amino acid concentration
Amino acid concentration measured by ELISA
Measured: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Plasma metabolomics
Plasma metabolomics by chromatography-mass spectrometry
Measured: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Skeletal muscle protein expression
Alterations in Skeletal muscle protein expression
Measured: Pre (week0) to mid (week3)
Skeletal muscle protein expression
Alterations in Skeletal muscle protein expression
Measured: Pre (week0) to Post (week6)
Haemoglobin mass expressed in grams
Haemoglobin mass measured via inhalation of carbon monoxide (CO) using the modified CO-rebreathing method
Measured: Pre (week0) to mid (week3)
Haemoglobin mass expressed in grams
Haemoglobin mass measured via inhalation of carbon monoxide (CO) using the modified CO-rebreathing method
Measured: Pre (week0) to Post (week6)
Blood volume in ml
Blood volume measured via inhalation of carbon monoxide (CO) using the modified CO-rebreathing method
Measured: Pre (week0) to Post (week6)
Blood volume in ml
Blood volume measured via inhalation of carbon monoxide (CO) using the modified CO-rebreathing method
Measured: Pre (week0) to Mid (week3)
Energy expenditure measured as energy intake to maintain body weight
Daily energy intake during intervention measured in Mega Joules
Measured: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start23 Feb 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Model description
- A pair-matched group, parallel design within each sex
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Principal investigator, Bente Kiens, University of Copenhagen
- Investigators
- Nicki W Almquist, Post Doc, Study director, University of CopenhagenBente Kiens, Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426447
- Sponsor's protocol ID
- PROPER
- Acronym
- PROPER
- Status last verified
- May 2024
- First submitted
- 22 Sep 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Dietary Protein, Performance and Health
- ClinicalTrials.gov ID
- NCT05426447
- Acronym / sponsor ID
- PROPER / PROPER
- Conditions
- Diet, Healthy, Protein Deficiency
- Keywords
- Diet intervention, Endurance athletes, Endurance performance, Skeletal muscle protein synthesis, Protein intake, Health markers, Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jun 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.
The present study is a parallel group design with randomised allocation to either a 1) reduced protein diet (RP) or a 2) normal protein diet (NP). The two groups will be pair-matched based on habitual dietary protein intake, endurance training, endurance performance, and sex.
The aim of the study is to investigate the effects of reducing dietary protein (~1g protein/kg body mass) compared to an eucaloric normal protein diet (~2g protein/kg body mass) for 6 weeks in well-trained endurance athletes on endurance performance, body composition, skeletal muscle protein synthesis, and health-related outcomes.
The hypothesis is that endurance performance will maintain or even be improved in well-trained endurance athletes after a 6-week dietary intervention of an eucaloric, protein reduced diet compared to a normal protein rich diet.
Detailed description
Design: The present study will include two phases: a 3-week run-in period, and a 6-week intervention of controlled diets containing either a reduced dietary protein (RP) or normal (habitual) protein (NP). The run-in period serves as a period for obtaining general activity data and habitual dietary and training habits in order to match the groups before entering the dietary intervention period.
Subjects and dietary goals: The study is aiming at including 20 male endurance athletes exercising ~15hrs+/week. The 20 males will be pair-matched based on habitual endurance training, habitual dietary protein intake, and endurance performance, and allocated in a randomised order to: 1) a reduced-protein diet (RP) or 2) a normal-protein diet (NP).
3-weeks run-in period: After a minimum of 7 days after written consent has been obtained, the run-in period will begin. Habitual endurance training volumes will be registered in an online platform (TrainingPeaks) and daily activity level will be monitored using an accelerometer (SENS) throughout the run-in and diet intervention period. "Heavy water" (D2O) will be ingested in a large bolus (3.5ml/kg LBM) upon beginning of the run-in period and plasma enrichments will be maintained throughout the study period by ingesting small daily boluses. This serves to determine skeletal muscle protein synthesis throughout the study.
6-weeks dietary intervention: The diets will be eucaloric and the estimated energy percentages for macronutrients will be as follows: RP - Protein ~7E%, Carbohydrate ~63E%, Fat ~29E%. NP - Protein ~16E%, Carbohydrate ~53E%, Fat ~30E%. Weekly urine and faeces samples will be collected during the run-in period and dietary intervention and the controlled diets will be supplied weekly for the participants.
Testing: Extensive endurance performance and metabolic testing will be performed prior to-, and during the intervention on weeks -1, 0 (Pre), 3 (Mid), and 6 (Post). The tests include: Body composition by DXA-scanning, resting metabolic rate by online respirometry using a Vyntus (Jaeger, PCX), venous blood-, and skeletal muscle biopsy sampling from m. Vastus Lateralis, a standardised breakfasts, endurance cycling on an electro-magnetically braked bike (Lode Excalibur) or running on a motorised treadmill (Woodway), and haemoglobin mass measuring using a modified version of the CO-rebreathing method.
The body mass will be kept unchanged during the 6-weeks dietary intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pair-matched group, parallel design within each sex
| Arm | Type | Receives |
|---|---|---|
| Reduced protein diet | Experimental | Other: Dietary intervention of reduced protein intakeA 6-week eucaloric dietary intervention of reduced protein intake (~1g protein/kg body mass). The diet will, hence, contain ~7E% protein, ~63E% carbohydrate, and ~29E% fat. Participants are free-living and receive all food pre-packed from the study kitchen. The energy provision will be set to match energy balance. |
| Normal protein diet | Active comparator | Other: Dietary intervention of normal protein intakeA 6-week eucaloric dietary intervention of normal protein intake (~2g protein/kg body mass). The diet will, hence, contain ~16E% protein, ~53E% carbohydrate, and ~30E% fat. Participants are free-living and receive all food pre-packed from the study kitchen. The energy provision will be set to match energy balance. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Endurance athlete
- Exercising at least 10hrs per week
- Habitual dietary protein intake ~2g/kg body mass
- BMI<25
Key exclusion criteria (2 listed)
- Food allergies that exclude the controlled diet
- Inconsistent endurance training load
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 |
|---|---|---|
| Dietary intervention of reduced protein intake6-wk dietary intervention of reduced protein intake | Other | Reduced protein diet |
| Dietary intervention of normal protein intake6-wk dietary intervention of normal protein intake | Other | Normal protein diet |
Primary outcome
Endurance performance on a bike
Time frame: From Pre (week0) to post (week6)
Endurance performance defined as maximal aerobic power (Wmax) during incremental test to exhaustion on a bike measured as 1-minute mean power output (W)
Microbiome
Time frame: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Diversity of bacterial strains in gut microbiome measured in feces samples
39 secondary outcomes
Resting metabolic rate
Time frame: Pre (week0) to mid (week3)
Resting metabolic rate
Time frame: Pre (week0) to Post (week6)
Lean body mass
Time frame: Run-in (week-3) to Pre (week0)
Lean body mass
Time frame: Pre (week0) to Post (week6)
Total fat mass
Time frame: Pre (week0) to Post (week6)
Total fat mass
Time frame: Pre (week0) to mid (week3)
Total fat mass
Time frame: Run-in (week-3) to Pre (week0)
Power output at 4mmol/L blood lactate
Time frame: Pre (week0) to mid (week3)
Power output at 4mmol/L blood lactate
Time frame: Pre (week0) to Post (week6)
Fractional utilisation of maximal oxygen uptake at 4mmol/L blood lactate
Time frame: Pre (week0) to mid (week3)
Fractional utilisation of maximal oxygen uptake at 4mmol/L blood lactate
Time frame: Pre (week0) to Post (week6)
Maximal oxygen uptake VO2peak
Time frame: Pre (week0) to mid (week3)
Maximal oxygen uptake VO2peak
Time frame: Pre (week0) to Post (week6)
Peak power output on a 10-seconds sprint
Time frame: Pre (week0) to mid (week3)
Peak power output on a 10-seconds sprint
Time frame: Pre (week0) to Post (week6)
Mean power output on a 10-seconds sprint
Time frame: Pre (week0) to mid (week3)
Mean power output on a 10-seconds sprint
Time frame: Pre (week0) to Post (week6)
Gross efficiency on a bike
Time frame: Pre (week0) to mid (week3)
Gross work efficiency on a bike
Time frame: Pre (week0) to Post (week6)
15-minute time-trial power output on a bike
Time frame: Pre (week0) to mid (week3)
15-minute time-trial power output on a bike
Time frame: Pre (week0) to Post (week6)
Fractional utilisation of maximal oxygen uptake during 15-minute time-trial
Time frame: Pre (week0) to mid (week3)
Fractional utilisation of maximal oxygen uptake during 15-minute time-trial
Time frame: Pre (week0) to Post (week6)
Respiratory exchange ratio
Time frame: Pre (week0) to Post (week6)
Respiratory exchange ratio
Time frame: Pre (week0) to Mid (week3)
Training load
Time frame: Run-in (week-3) vs dietary intervention (week0 to week6)
Energy intake
Time frame: Run-in (week-3) vs dietary intervention (week0 to week6)
Energy expenditure
Time frame: Run-in (week-3) vs dietary intervention (week0 to week6)
Blood lactate concentration
Time frame: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Blood glucose concentration
Time frame: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Blood amino acid concentration
Time frame: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Plasma metabolomics
Time frame: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Skeletal muscle protein expression
Time frame: Pre (week0) to mid (week3)
Skeletal muscle protein expression
Time frame: Pre (week0) to Post (week6)
Haemoglobin mass expressed in grams
Time frame: Pre (week0) to mid (week3)
Haemoglobin mass expressed in grams
Time frame: Pre (week0) to Post (week6)
Blood volume in ml
Time frame: Pre (week0) to Post (week6)
Blood volume in ml
Time frame: Pre (week0) to Mid (week3)
Energy expenditure measured as energy intake to maintain body weight
Time frame: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- 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.
Nicki W Almquist, Post Doc study director
University of Copenhagen
Bente Kiens, Professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention of reduced protein intake and Dietary intervention of normal protein intake in people with Diet, Healthy and Protein Deficiency, run by University of Copenhagen at 1 site in Denmark.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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 Denmark. 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?
Results are not available in the source record.
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?
Endurance performance on a bike (time frame: From Pre (week0) to post (week6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2024.