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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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05426447
Study type Interventional
Source University of Copenhagen
Contact
Status Active, not recruiting
Phase N/A
Start date February 23, 2021
Completion date December 31, 2025

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