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ExerciseNCT03462381

Protein Supplementation and Endurance Exercise Adaptations

A study testing Protein in people with Exercise, run by Wageningen University at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
Exercise
What is being tested?
Protein
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteNetherlands
Study dates
1 Aug 2017to 1 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Wageningen University & Research

    Wageningen, Gelderland, 6708 WE

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Conditions
Exercise
Being tested
Protein
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProteinDietary supplement

    Three endurance training sessions weekly with protein supplementation post-exercise and before sleep.

Study groups in NCT03462381
Study groupRoleWhat they receive
ProteinExperimentalThree endurance training sessions weekly with protein supplementation post-exercise and before sleep.
Receives: Dietary Supplement: Protein
CarbohydratePlacebo comparatorThree endurance training sessions weekly with carbohydrate supplementation post-exercise and before sleep.
Receives: Dietary Supplement: Protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal whole-body oxidative capacity

    Maximal oxygen consumption in ml per kg of bodyweight

    Measured: Baseline

  2. Maximal whole-body oxidative capacity

    Maximal oxygen consumption in ml per kg of bodyweight

    Measured: 6 weeks

  3. Maximal whole-body oxidative capacity

    Maximal oxygen consumption in ml per kg of bodyweight

    Measured: 12 weeks

Secondary outcomes (36)

  1. Endurance Performance

    10-km simulated time trial performance in seconds

    Measured: Baseline

  2. Endurance Performance

    10-km simulated time trial performance in seconds

    Measured: 6 weeks

  3. Endurance Performance

    10-km simulated time trial performance in seconds

    Measured: 12 weeks

  4. Maximal activity of citrate synthase

    Maximal activity of citrate synthase in micromol per gram per minute

    Measured: Baseline

  5. Maximal activity of citrate synthase

    Maximal activity of citrate synthase in micromol per gram per minute

    Measured: 6 weeks

  6. Maximal activity of citrate synthase

    Maximal activity of citrate synthase in micromol per gram per minute

    Measured: 12 weeks

  7. Maximal activity of Cytochrome c oxidase

    Maximal activity of Cytochrome c oxidase in micromol per gram per minute

    Measured: Baseline

  8. Maximal activity of Cytochrome c oxidase

    Maximal activity of Cytochrome c oxidase in micromol per gram per minute

    Measured: 6 weeks

  9. Maximal activity of Cytochrome c oxidase

    Maximal activity of Cytochrome c oxidase in micromol per gram per minute

    Measured: 12 weeks

  10. Erythrocytes

    Erythrocytes count/pL

    Measured: Baseline

  11. Erythrocytes

    Erythrocytes count/pL

    Measured: 2 weeks

  12. Erythrocytes

    Erythrocytes count/pL

    Measured: 4 weeks

  13. Erythrocytes

    Erythrocytes count/pL

    Measured: 6 weeks

  14. Erythrocytes

    Erythrocytes count/pL

    Measured: 8 weeks

  15. Erythrocytes

    Erythrocytes count/pL

    Measured: 10 weeks

  16. Erythrocytes

    Erythrocytes count/pL

    Measured: 12 weeks

  17. Hemoglobin

    Hemoglobin mmol/L

    Measured: Baseline

  18. Hemoglobin

    Hemoglobin mmol/L

    Measured: 2 weeks

  19. Hemoglobin

    Hemoglobin mmol/L

    Measured: 4 weeks

  20. Hemoglobin

    Hemoglobin mmol/L

    Measured: 6 weeks

  21. Hemoglobin

    Hemoglobin mmol/L

    Measured: 8 weeks

  22. Hemoglobin

    Hemoglobin mmol/L

    Measured: 10 weeks

  23. Hemoglobin

    Hemoglobin mmol/L

    Measured: 12 weeks

  24. Hematocrit

    Hematocrit L/L

    Measured: Baseline

  25. Hematocrit

    Hematocrit L/L

    Measured: 2 weeks

  26. Hematocrit

    Hematocrit L/L

    Measured: 4 weeks

  27. Hematocrit

    Hematocrit L/L

    Measured: 6 weeks

  28. Hematocrit

    Hematocrit L/L

    Measured: 8 weeks

  29. Hematocrit

    Hematocrit L/L

    Measured: 10 weeks

  30. Hematocrit

    Hematocrit L/L

    Measured: 12 weeks

  31. Lean mass

    Lean mass kg

    Measured: Baseline

  32. Lean mass

    Lean mass kg

    Measured: 6 weeks

  33. Lean mass

    Lean mass kg

    Measured: 12 weeks

  34. Fat mass

    Fat mass kg

    Measured: Baseline

  35. Fat mass

    Fat mass kg

    Measured: 6 weeks

  36. Fat mass

    Fat mass kg

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2018
  2. Study start1 Aug 2017
  3. Primary completion28 May 2018
  4. Study completion1 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03462381
Sponsor's protocol ID
NL5988508116
Status last verified
Mar 2019
First submitted
26 Sep 2017
Last updated
20 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32517654

  • 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.

    PubMed 31240303

Questions about this trial

What is this clinical trial studying?

A study testing Protein in people with Exercise, run by Wageningen University at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal whole-body oxidative capacity (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03462381, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.

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