ClinicalTrials.gg
CompletedNCT03462381Updated Mar 20, 2019

Protein Supplementation and Endurance Exercise Adaptations

An interventional study of Protein in Exercise, sponsored by Wageningen University. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by Wageningen University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies testing proteins in Motor Activity — 1 open to participants now, 1 under way, 1 of them phase 3. Proteins · Motor Activity.

Enrollment
5th of 10
44 · median 38
Started
2017
with 1 other
No phase
9 of 10
none open now
Registered
5th of 10
by date
Lead sponsor
1 of 10
Wageningen University

Among the 10 studies testing proteins in Motor Activity, this one is the 5th largest by enrollment, is one of 2 that started in 2017, is one of 9 with no phase, and was the 5th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

1 of the 10 studies testing proteins in Motor Activity is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

About proteins

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years to 30 Years · male · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies testing proteins in Motor Activity, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Exercise

Browse trials for

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male
  • Age between 18 and 30 years of age
  • 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
  • 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

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 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)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Protein

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

    Dietary Supplement: Protein

  • Placebo comparator
    Carbohydrate

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

    Dietary Supplement: Protein

Interventions

  • Dietary supplementProtein

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

06

What researchers measure

Primary outcomes

  1. Maximal whole-body oxidative capacity

    Maximal oxygen consumption in ml per kg of bodyweight

    Time frame: Baseline

  2. Maximal whole-body oxidative capacity

    Maximal oxygen consumption in ml per kg of bodyweight

    Time frame: 6 weeks

  3. Maximal whole-body oxidative capacity

    Maximal oxygen consumption in ml per kg of bodyweight

    Time frame: 12 weeks

Secondary outcomes

  1. Endurance Performance

    10-km simulated time trial performance in seconds

    Time frame: Baseline

  2. Endurance Performance

    10-km simulated time trial performance in seconds

    Time frame: 6 weeks

  3. Endurance Performance

    10-km simulated time trial performance in seconds

    Time frame: 12 weeks

  4. Maximal activity of citrate synthase

    Maximal activity of citrate synthase in micromol per gram per minute

    Time frame: Baseline

  5. Maximal activity of citrate synthase

    Maximal activity of citrate synthase in micromol per gram per minute

    Time frame: 6 weeks

  6. Maximal activity of citrate synthase

    Maximal activity of citrate synthase in micromol per gram per minute

    Time frame: 12 weeks

  7. Maximal activity of Cytochrome c oxidase

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

    Time frame: Baseline

  8. Maximal activity of Cytochrome c oxidase

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

    Time frame: 6 weeks

  9. Maximal activity of Cytochrome c oxidase

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

    Time frame: 12 weeks

  10. Erythrocytes

    Erythrocytes count/pL

    Time frame: Baseline

  11. Erythrocytes

    Erythrocytes count/pL

    Time frame: 2 weeks

  12. Erythrocytes

    Erythrocytes count/pL

    Time frame: 4 weeks

  13. Erythrocytes

    Erythrocytes count/pL

    Time frame: 6 weeks

  14. Erythrocytes

    Erythrocytes count/pL

    Time frame: 8 weeks

  15. Erythrocytes

    Erythrocytes count/pL

    Time frame: 10 weeks

  16. Erythrocytes

    Erythrocytes count/pL

    Time frame: 12 weeks

  17. Hemoglobin

    Hemoglobin mmol/L

    Time frame: Baseline

  18. Hemoglobin

    Hemoglobin mmol/L

    Time frame: 2 weeks

  19. Hemoglobin

    Hemoglobin mmol/L

    Time frame: 4 weeks

  20. Hemoglobin

    Hemoglobin mmol/L

    Time frame: 6 weeks

  21. Hemoglobin

    Hemoglobin mmol/L

    Time frame: 8 weeks

  22. Hemoglobin

    Hemoglobin mmol/L

    Time frame: 10 weeks

  23. Hemoglobin

    Hemoglobin mmol/L

    Time frame: 12 weeks

  24. Hematocrit

    Hematocrit L/L

    Time frame: Baseline

  25. Hematocrit

    Hematocrit L/L

    Time frame: 2 weeks

  26. Hematocrit

    Hematocrit L/L

    Time frame: 4 weeks

  27. Hematocrit

    Hematocrit L/L

    Time frame: 6 weeks

  28. Hematocrit

    Hematocrit L/L

    Time frame: 8 weeks

  29. Hematocrit

    Hematocrit L/L

    Time frame: 10 weeks

  30. Hematocrit

    Hematocrit L/L

    Time frame: 12 weeks

  31. Lean mass

    Lean mass kg

    Time frame: Baseline

  32. Lean mass

    Lean mass kg

    Time frame: 6 weeks

  33. Lean mass

    Lean mass kg

    Time frame: 12 weeks

  34. Fat mass

    Fat mass kg

    Time frame: Baseline

  35. Fat mass

    Fat mass kg

    Time frame: 6 weeks

  36. Fat mass

    Fat mass kg

    Time frame: 12 weeks

07

Study locations

1 site
  • Wageningen University & Research
    Wageningen, Gelderland 6708 WE, Netherlands
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in May 2018, 9 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 9 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2017
First posted
Mar 12, 2018
StartActual
Aug 1, 2017
Primary completionActual
May 28, 2018
CompletionActual
Jun 1, 2018
Last update
Mar 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03462381
Responsible party
Sponsor
First posted
Mar 12, 2018
Start date
Aug 1, 2017
Primary completion
May 28, 2018
Completion
Jun 1, 2018
Last update
Mar 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Proteins

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