Protein Supplementation and Endurance Exercise Adaptations

March 16, 2019 updated by: Wageningen University

The Impact of Protein Supplementation to Maximize Skeletal Muscle Endurance Training Adaptations in Healthy Young Men

Participants will perform three endurance training sessions weekly for 12 weeks. All participants will be randomly assigned to the protein supplementation group or the placebo (iso-caloric carbohydrate) group. During the 12 weeks endurance training program participants allocated to the protein group (30 g protein per beverage) will receive a protein drink after exercise and prior to sleep at night on training days. On non-training days participants will only receive a protein drink before sleep. Participants allocated to the carbohydrate group (30 g carbohydrates) will receive a carbohydrate drink instead of a protein drink.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the proposed study, the effects of protein supplementation after training and before sleep on VO2max and performance will be assessed during 12 weeks endurance exercise training in untrained healthy young men. The ready to drink carbohydrate beverage consists of 30g carbohydrate or 30g protein. Previous studies show that the supplementation of 30g protein is in the optimal range to stimulate the muscle protein synthetic response following resistance type exercise. The protein supplementation group in the present study will be compared with an iso-caloric carbohydrate group. In addition, to the pre- and post-intervention biopsies 1 additional muscle biopsies will be taken (in week 6) during the 12 week intervention period. This will create a unique opportunity to establish the timeline of the skeletal muscle adaptive response at functional and mechanistic level following prolonged endurance exercise training, including potential differences between both groups.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6708 WE
        • Wageningen University & Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Age between 18 and 30 years of age
  • BMI between 18.5 - 25 kg/m2
  • Recreationally active, performing sports on a non-competitive basis
  • Maximal wattage of > 5 watt per kg bodyweight (screening measurement)
  • Willing to give muscle biopsies
  • Willing to give blood samples
  • Having a general-practitioner
  • Consumption of alcohol beverages is less than 21 per week
  • Able to perform three exercise sessions weekly for 10 weeks

Exclusion Criteria:

  • Medical condition that can interfere with the study outcome (i.e. cardiovascular disease, pulmonary disease, liver or renal disease, diabetes mellitus type 1 or 2)
  • Having a lactose and/or gluten intolerance
  • Use of systemic medication (with the exception of antihistaminic medication and the use of occasional painkillers)
  • (Chronic) injuries of the locomotor system (e.g. musculoskeletal/orthopedic disorders) that can interfere with the intervention
  • Participants who are enrolled in an interventional biomedical research project or have received an investigational new drug or product with the last 30 days prior to screening.
  • Smokers and use of illicit drugs
  • Blood donor during the study and in the three months before start of the study
  • Employed, or intern, or working on a thesis at the department of Human Nutrition at Wageningen University & Research
  • Participating in another scientific study (except EetMeetWeet)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Protein
Three endurance training sessions weekly with protein supplementation post-exercise and before sleep.
Three endurance training sessions weekly with protein supplementation post-exercise and before sleep.
PLACEBO_COMPARATOR: Carbohydrate
Three endurance training sessions weekly with carbohydrate supplementation post-exercise and before sleep.
Three endurance training sessions weekly with protein supplementation post-exercise and before sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal whole-body oxidative capacity
Time Frame: Baseline
Maximal oxygen consumption in ml per kg of bodyweight
Baseline
Maximal whole-body oxidative capacity
Time Frame: 6 weeks
Maximal oxygen consumption in ml per kg of bodyweight
6 weeks
Maximal whole-body oxidative capacity
Time Frame: 12 weeks
Maximal oxygen consumption in ml per kg of bodyweight
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endurance Performance
Time Frame: Baseline
10-km simulated time trial performance in seconds
Baseline
Endurance Performance
Time Frame: 6 weeks
10-km simulated time trial performance in seconds
6 weeks
Endurance Performance
Time Frame: 12 weeks
10-km simulated time trial performance in seconds
12 weeks
Maximal activity of citrate synthase
Time Frame: Baseline
Maximal activity of citrate synthase in micromol per gram per minute
Baseline
Maximal activity of citrate synthase
Time Frame: 6 weeks
Maximal activity of citrate synthase in micromol per gram per minute
6 weeks
Maximal activity of citrate synthase
Time Frame: 12 weeks
Maximal activity of citrate synthase in micromol per gram per minute
12 weeks
Maximal activity of Cytochrome c oxidase
Time Frame: Baseline
Maximal activity of Cytochrome c oxidase in micromol per gram per minute
Baseline
Maximal activity of Cytochrome c oxidase
Time Frame: 6 weeks
Maximal activity of Cytochrome c oxidase in micromol per gram per minute
6 weeks
Maximal activity of Cytochrome c oxidase
Time Frame: 12 weeks
Maximal activity of Cytochrome c oxidase in micromol per gram per minute
12 weeks
Erythrocytes
Time Frame: Baseline
Erythrocytes count/pL
Baseline
Erythrocytes
Time Frame: 2 weeks
Erythrocytes count/pL
2 weeks
Erythrocytes
Time Frame: 4 weeks
Erythrocytes count/pL
4 weeks
Erythrocytes
Time Frame: 6 weeks
Erythrocytes count/pL
6 weeks
Erythrocytes
Time Frame: 8 weeks
Erythrocytes count/pL
8 weeks
Erythrocytes
Time Frame: 10 weeks
Erythrocytes count/pL
10 weeks
Erythrocytes
Time Frame: 12 weeks
Erythrocytes count/pL
12 weeks
Hemoglobin
Time Frame: Baseline
Hemoglobin mmol/L
Baseline
Hemoglobin
Time Frame: 2 weeks
Hemoglobin mmol/L
2 weeks
Hemoglobin
Time Frame: 4 weeks
Hemoglobin mmol/L
4 weeks
Hemoglobin
Time Frame: 6 weeks
Hemoglobin mmol/L
6 weeks
Hemoglobin
Time Frame: 8 weeks
Hemoglobin mmol/L
8 weeks
Hemoglobin
Time Frame: 10 weeks
Hemoglobin mmol/L
10 weeks
Hemoglobin
Time Frame: 12 weeks
Hemoglobin mmol/L
12 weeks
Hematocrit
Time Frame: Baseline
Hematocrit L/L
Baseline
Hematocrit
Time Frame: 2 weeks
Hematocrit L/L
2 weeks
Hematocrit
Time Frame: 4 weeks
Hematocrit L/L
4 weeks
Hematocrit
Time Frame: 6 weeks
Hematocrit L/L
6 weeks
Hematocrit
Time Frame: 8 weeks
Hematocrit L/L
8 weeks
Hematocrit
Time Frame: 10 weeks
Hematocrit L/L
10 weeks
Hematocrit
Time Frame: 12 weeks
Hematocrit L/L
12 weeks
Lean mass
Time Frame: Baseline
Lean mass kg
Baseline
Lean mass
Time Frame: 6 weeks
Lean mass kg
6 weeks
Lean mass
Time Frame: 12 weeks
Lean mass kg
12 weeks
Fat mass
Time Frame: Baseline
Fat mass kg
Baseline
Fat mass
Time Frame: 6 weeks
Fat mass kg
6 weeks
Fat mass
Time Frame: 12 weeks
Fat mass kg
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2017

Primary Completion (ACTUAL)

May 28, 2018

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

September 26, 2017

First Submitted That Met QC Criteria

March 8, 2018

First Posted (ACTUAL)

March 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 16, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • NL5988508116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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