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Completed

NCT Number: NCT03462381

Protein Supplementation and Endurance Exercise Adaptations

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University & Research

Wageningen, Gelderland, 6708 WE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Protein

Dietary Supplement

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

Primary outcomes

  1. Maximal whole-body oxidative capacity

    Time frame: Baseline

    Maximal oxygen consumption in ml per kg of bodyweight

  2. Maximal whole-body oxidative capacity

    Time frame: 6 weeks

    Maximal oxygen consumption in ml per kg of bodyweight

  3. Maximal whole-body oxidative capacity

    Time frame: 12 weeks

    Maximal oxygen consumption in ml per kg of bodyweight

Secondary outcomes

  1. Endurance Performance

    Time frame: Baseline

    10-km simulated time trial performance in seconds

  2. Endurance Performance

    Time frame: 6 weeks

    10-km simulated time trial performance in seconds

  3. Endurance Performance

    Time frame: 12 weeks

    10-km simulated time trial performance in seconds

  4. Maximal activity of citrate synthase

    Time frame: Baseline

    Maximal activity of citrate synthase in micromol per gram per minute

  5. Maximal activity of citrate synthase

    Time frame: 6 weeks

    Maximal activity of citrate synthase in micromol per gram per minute

  6. Maximal activity of citrate synthase

    Time frame: 12 weeks

    Maximal activity of citrate synthase in micromol per gram per minute

  7. Maximal activity of Cytochrome c oxidase

    Time frame: Baseline

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

  8. Maximal activity of Cytochrome c oxidase

    Time frame: 6 weeks

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

  9. Maximal activity of Cytochrome c oxidase

    Time frame: 12 weeks

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

  10. Erythrocytes

    Time frame: Baseline

    Erythrocytes count/pL

  11. Erythrocytes

    Time frame: 2 weeks

    Erythrocytes count/pL

  12. Erythrocytes

    Time frame: 4 weeks

    Erythrocytes count/pL

  13. Erythrocytes

    Time frame: 6 weeks

    Erythrocytes count/pL

  14. Erythrocytes

    Time frame: 8 weeks

    Erythrocytes count/pL

  15. Erythrocytes

    Time frame: 10 weeks

    Erythrocytes count/pL

  16. Erythrocytes

    Time frame: 12 weeks

    Erythrocytes count/pL

  17. Hemoglobin

    Time frame: Baseline

    Hemoglobin mmol/L

  18. Hemoglobin

    Time frame: 2 weeks

    Hemoglobin mmol/L

  19. Hemoglobin

    Time frame: 4 weeks

    Hemoglobin mmol/L

  20. Hemoglobin

    Time frame: 6 weeks

    Hemoglobin mmol/L

  21. Hemoglobin

    Time frame: 8 weeks

    Hemoglobin mmol/L

  22. Hemoglobin

    Time frame: 10 weeks

    Hemoglobin mmol/L

  23. Hemoglobin

    Time frame: 12 weeks

    Hemoglobin mmol/L

  24. Hematocrit

    Time frame: Baseline

    Hematocrit L/L

  25. Hematocrit

    Time frame: 2 weeks

    Hematocrit L/L

  26. Hematocrit

    Time frame: 4 weeks

    Hematocrit L/L

  27. Hematocrit

    Time frame: 6 weeks

    Hematocrit L/L

  28. Hematocrit

    Time frame: 8 weeks

    Hematocrit L/L

  29. Hematocrit

    Time frame: 10 weeks

    Hematocrit L/L

  30. Hematocrit

    Time frame: 12 weeks

    Hematocrit L/L

  31. Lean mass

    Time frame: Baseline

    Lean mass kg

  32. Lean mass

    Time frame: 6 weeks

    Lean mass kg

  33. Lean mass

    Time frame: 12 weeks

    Lean mass kg

  34. Fat mass

    Time frame: Baseline

    Fat mass kg

  35. Fat mass

    Time frame: 6 weeks

    Fat mass kg

  36. Fat mass

    Time frame: 12 weeks

    Fat mass kg

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 12, 2018
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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