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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05426447
Other study ID # PROPER
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 23, 2021
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Endurance athlete - Exercising at least 10hrs per week - Habitual dietary protein intake ~2g/kg body mass - BMI<25 Exclusion Criteria: - Food allergies that exclude the controlled diet - Inconsistent endurance training load

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dietary intervention of reduced protein intake
6-wk dietary intervention of reduced protein intake
Dietary intervention of normal protein intake
6-wk dietary intervention of normal protein intake

Locations

Country Name City State
Denmark University of Copenhagen Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
University of Copenhagen Maastricht University Medical Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) From Pre (week0) to post (week6)
Primary Microbiome Diversity of bacterial strains in gut microbiome measured in feces samples Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Secondary Resting metabolic rate Measured in an over-night fasted state via indirect calorimetry expressed in MJ/day Pre (week0) to mid (week3)
Secondary Resting metabolic rate Measured in an over-night fasted state via indirect calorimetry expressed in MJ/day Pre (week0) to Post (week6)
Secondary Lean body mass Measured by dual-energy x-ray (DXA)-scanningg expressed in kg Run-in (week-3) to Pre (week0)
Secondary Lean body mass Measured by dual-energy x-ray (DXA)-scanning expressed in kg Pre (week0) to Post (week6)
Secondary Total fat mass Measured by dual-energy x-ray (DXA)-scanning expressed in kg Pre (week0) to Post (week6)
Secondary Total fat mass Measured by dual-energy x-ray (DXA)-scanning expressed in kg Pre (week0) to mid (week3)
Secondary Total fat mass Measured by dual-energy x-ray (DXA)-scanning expressed in kg Run-in (week-3) to Pre (week0)
Secondary Power output at 4mmol/L blood lactate Alterations in Power output at 4mmol/L blood lactate in response to diet Pre (week0) to mid (week3)
Secondary Power output at 4mmol/L blood lactate Alterations in Power output at 4mmol/L blood lactate in response to diet Pre (week0) to Post (week6)
Secondary 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 Pre (week0) to mid (week3)
Secondary 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 Pre (week0) to Post (week6)
Secondary Maximal oxygen uptake VO2peak Alterations in Maximal oxygen uptake VO2peak measured by an online VO2 apparatus Pre (week0) to mid (week3)
Secondary Maximal oxygen uptake VO2peak Alterations in Maximal oxygen uptake VO2peak measured by an online VO2 apparatus Pre (week0) to Post (week6)
Secondary Peak power output on a 10-seconds sprint Alterations in peak power output on a 10-seconds sprint in response to diet Pre (week0) to mid (week3)
Secondary Peak power output on a 10-seconds sprint Alterations in peak power output on a 10-seconds sprint in response to diet Pre (week0) to Post (week6)
Secondary Mean power output on a 10-seconds sprint Alterations in mean power output on a 10-seconds sprint in response to diet Pre (week0) to mid (week3)
Secondary Mean power output on a 10-seconds sprint Alterations in mean power output on a 10-seconds sprint in response to diet Pre (week0) to Post (week6)
Secondary Gross efficiency on a bike Gross efficiency expressed as % of external power compared to internal (metabolic) power Pre (week0) to mid (week3)
Secondary Gross work efficiency on a bike Gross efficiency expressed as % of external power compared to internal (metabolic) power Pre (week0) to Post (week6)
Secondary 15-minute time-trial power output on a bike Alterations in 15-minute time-trial mean power output Pre (week0) to mid (week3)
Secondary 15-minute time-trial power output on a bike Alterations in 15-minute time-trial mean power output Pre (week0) to Post (week6)
Secondary Fractional utilisation of maximal oxygen uptake during 15-minute time-trial Alterations in Fractional utilisation of maximal oxygen uptake during 15-minute time-trial Pre (week0) to mid (week3)
Secondary Fractional utilisation of maximal oxygen uptake during 15-minute time-trial Alterations in Fractional utilisation of maximal oxygen uptake during 15-minute time-trial Pre (week0) to Post (week6)
Secondary Respiratory exchange ratio respiratory exchange ratio (RER) during rest and exercise using indirect calorimetry Pre (week0) to Post (week6)
Secondary Respiratory exchange ratio respiratory exchange ratio (RER) during rest and exercise using indirect calorimetry Pre (week0) to Mid (week3)
Secondary Training load Training load as quantified by Edward's Training Impulse based on heart rate zones Run-in (week-3) vs dietary intervention (week0 to week6)
Secondary Energy intake Habitual energy intake registered by food diaries expressed in Mega Joules Run-in (week-3) vs dietary intervention (week0 to week6)
Secondary Energy expenditure Energy expenditure is measured by combining resting metabolic rate and daily activity recording from accelerometer data and heart rate monitor Run-in (week-3) vs dietary intervention (week0 to week6)
Secondary Blood lactate concentration Glucose lactate measured in fasted state on an ABL800 Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Secondary Blood glucose concentration Glucose concentration measured in fasted state on an ABL800 Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Secondary Blood amino acid concentration Amino acid concentration measured by ELISA Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Secondary Plasma metabolomics Plasma metabolomics by chromatography-mass spectrometry Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
Secondary Skeletal muscle protein expression Alterations in Skeletal muscle protein expression Pre (week0) to mid (week3)
Secondary Skeletal muscle protein expression Alterations in Skeletal muscle protein expression Pre (week0) to Post (week6)
Secondary Haemoglobin mass expressed in grams Haemoglobin mass measured via inhalation of carbon monoxide (CO) using the modified CO-rebreathing method Pre (week0) to mid (week3)
Secondary Haemoglobin mass expressed in grams Haemoglobin mass measured via inhalation of carbon monoxide (CO) using the modified CO-rebreathing method Pre (week0) to Post (week6)
Secondary Blood volume in ml Blood volume measured via inhalation of carbon monoxide (CO) using the modified CO-rebreathing method Pre (week0) to Post (week6)
Secondary Blood volume in ml Blood volume measured via inhalation of carbon monoxide (CO) using the modified CO-rebreathing method Pre (week0) to Mid (week3)
Secondary Energy expenditure measured as energy intake to maintain body weight Daily energy intake during intervention measured in Mega Joules Run-in (week-3 to week0) vs dietary intervention (week0 to week6)
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