NCT03462381

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

September 26, 2017

Last Update Submit

March 16, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Maximal whole-body oxidative capacity

    Maximal oxygen consumption in ml per kg of bodyweight

    Baseline

  • Maximal whole-body oxidative capacity

    Maximal oxygen consumption in ml per kg of bodyweight

    6 weeks

  • Maximal whole-body oxidative capacity

    Maximal oxygen consumption in ml per kg of bodyweight

    12 weeks

Secondary Outcomes (36)

  • Endurance Performance

    Baseline

  • Endurance Performance

    6 weeks

  • Endurance Performance

    12 weeks

  • Maximal activity of citrate synthase

    Baseline

  • Maximal activity of citrate synthase

    6 weeks

  • +31 more secondary outcomes

Study Arms (2)

Protein

EXPERIMENTAL

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

Dietary Supplement: Protein

Carbohydrate

PLACEBO COMPARATOR

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

Dietary Supplement: Protein

Interventions

ProteinDIETARY_SUPPLEMENT

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

CarbohydrateProtein

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsYoung healthy men
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University & Research

Wageningen, Gelderland, 6708 WE, Netherlands

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Proteins

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

March 12, 2018

Study Start

August 1, 2017

Primary Completion

May 28, 2018

Study Completion

June 1, 2018

Last Updated

March 20, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations