- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03462381
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
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.
Sponsor
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.
General Publications
- Knuiman P, Hangelbroek R, Boekschoten M, Hopman M, Mensink M. Impact of protein supplementation during endurance training on changes in skeletal muscle transcriptome. BMC Genomics. 2020 Jun 9;21(1):397. doi: 10.1186/s12864-020-6686-x.
- Knuiman P, van Loon LJC, Wouters J, Hopman M, Mensink M. Protein supplementation elicits greater gains in maximal oxygen uptake capacity and stimulates lean mass accretion during prolonged endurance training: a double-blind randomized controlled trial. Am J Clin Nutr. 2019 Aug 1;110(2):508-518. doi: 10.1093/ajcn/nqz093.
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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