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临床试验/NCT05426447
NCT05426447进行中(未招募)不适用

Reduced Dietary Protein, Performance and Health

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
Microbiome

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Endurance athlete
  • Exercising at least 10hrs per week
  • Habitual dietary protein intake ~2g/kg body mass

排除标准

  • Food allergies that exclude the controlled diet
  • Inconsistent endurance training load

结局指标

主要结局

Microbiome

时间窗: Run-in (week-3 to week0) vs dietary intervention (week0 to week6)

Diversity of bacterial strains in gut microbiome measured in feces samples

Endurance performance on a bike

时间窗: 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)

次要结局

  • Total fat mass(Run-in (week-3) to Pre (week0))
  • Training load(Run-in (week-3) vs dietary intervention (week0 to week6))
  • Resting metabolic rate(Pre (week0) to Post (week6))
  • Lean body mass(Pre (week0) to Post (week6))
  • Fractional utilisation of maximal oxygen uptake at 4mmol/L blood lactate(Pre (week0) to Post (week6))
  • Gross work efficiency on a bike(Pre (week0) to Post (week6))
  • Respiratory exchange ratio(Pre (week0) to Mid (week3))
  • Energy intake(Run-in (week-3) vs dietary intervention (week0 to week6))
  • Power output at 4mmol/L blood lactate(Pre (week0) to Post (week6))
  • Peak power output on a 10-seconds sprint(Pre (week0) to Post (week6))
  • Mean power output on a 10-seconds sprint(Pre (week0) to Post (week6))
  • Gross efficiency on a bike(Pre (week0) to mid (week3))
  • 15-minute time-trial power output on a bike(Pre (week0) to Post (week6))
  • Fractional utilisation of maximal oxygen uptake during 15-minute time-trial(Pre (week0) to Post (week6))
  • Blood lactate concentration(Run-in (week-3 to week0) vs dietary intervention (week0 to week6))
  • Plasma metabolomics(Run-in (week-3 to week0) vs dietary intervention (week0 to week6))
  • Skeletal muscle protein expression(Pre (week0) to Post (week6))
  • Maximal oxygen uptake VO2peak(Pre (week0) to Post (week6))
  • Energy expenditure(Run-in (week-3) vs dietary intervention (week0 to week6))
  • Blood glucose concentration(Run-in (week-3 to week0) vs dietary intervention (week0 to week6))
  • Haemoglobin mass expressed in grams(Pre (week0) to Post (week6))
  • Blood amino acid concentration(Run-in (week-3 to week0) vs dietary intervention (week0 to week6))
  • Blood volume in ml(Pre (week0) to Mid (week3))
  • Energy expenditure measured as energy intake to maintain body weight(Run-in (week-3 to week0) vs dietary intervention (week0 to week6))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bente Kiens

Professor of Exercise, Nutrition and Metabolism, D Sci, PhD, Principal Investigator

University of Copenhagen

研究点 (2)

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