Protein Supplementation and Endurance Exercise Adaptations

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462381
• Other study ID #: NL5988508116
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: March 2019
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 1, 2018
• Est. primary completion date: May 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Exercise

Intervention

Dietary Supplement:
• Protein
Three endurance training sessions weekly with protein supplementation post-exercise and before sleep.

Locations

Country	Name	City	State
Netherlands	Wageningen University & Research	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal whole-body oxidative capacity	Maximal oxygen consumption in ml per kg of bodyweight	Baseline
Primary	Maximal whole-body oxidative capacity	Maximal oxygen consumption in ml per kg of bodyweight	6 weeks
Primary	Maximal whole-body oxidative capacity	Maximal oxygen consumption in ml per kg of bodyweight	12 weeks
Secondary	Endurance Performance	10-km simulated time trial performance in seconds	Baseline
Secondary	Endurance Performance	10-km simulated time trial performance in seconds	6 weeks
Secondary	Endurance Performance	10-km simulated time trial performance in seconds	12 weeks
Secondary	Maximal activity of citrate synthase	Maximal activity of citrate synthase in micromol per gram per minute	Baseline
Secondary	Maximal activity of citrate synthase	Maximal activity of citrate synthase in micromol per gram per minute	6 weeks
Secondary	Maximal activity of citrate synthase	Maximal activity of citrate synthase in micromol per gram per minute	12 weeks
Secondary	Maximal activity of Cytochrome c oxidase	Maximal activity of Cytochrome c oxidase in micromol per gram per minute	Baseline
Secondary	Maximal activity of Cytochrome c oxidase	Maximal activity of Cytochrome c oxidase in micromol per gram per minute	6 weeks
Secondary	Maximal activity of Cytochrome c oxidase	Maximal activity of Cytochrome c oxidase in micromol per gram per minute	12 weeks
Secondary	Erythrocytes	Erythrocytes count/pL	Baseline
Secondary	Erythrocytes	Erythrocytes count/pL	2 weeks
Secondary	Erythrocytes	Erythrocytes count/pL	4 weeks
Secondary	Erythrocytes	Erythrocytes count/pL	6 weeks
Secondary	Erythrocytes	Erythrocytes count/pL	8 weeks
Secondary	Erythrocytes	Erythrocytes count/pL	10 weeks
Secondary	Erythrocytes	Erythrocytes count/pL	12 weeks
Secondary	Hemoglobin	Hemoglobin mmol/L	Baseline
Secondary	Hemoglobin	Hemoglobin mmol/L	2 weeks
Secondary	Hemoglobin	Hemoglobin mmol/L	4 weeks
Secondary	Hemoglobin	Hemoglobin mmol/L	6 weeks
Secondary	Hemoglobin	Hemoglobin mmol/L	8 weeks
Secondary	Hemoglobin	Hemoglobin mmol/L	10 weeks
Secondary	Hemoglobin	Hemoglobin mmol/L	12 weeks
Secondary	Hematocrit	Hematocrit L/L	Baseline
Secondary	Hematocrit	Hematocrit L/L	2 weeks
Secondary	Hematocrit	Hematocrit L/L	4 weeks
Secondary	Hematocrit	Hematocrit L/L	6 weeks
Secondary	Hematocrit	Hematocrit L/L	8 weeks
Secondary	Hematocrit	Hematocrit L/L	10 weeks
Secondary	Hematocrit	Hematocrit L/L	12 weeks
Secondary	Lean mass	Lean mass kg	Baseline
Secondary	Lean mass	Lean mass kg	6 weeks
Secondary	Lean mass	Lean mass kg	12 weeks
Secondary	Fat mass	Fat mass kg	Baseline
Secondary	Fat mass	Fat mass kg	6 weeks
Secondary	Fat mass	Fat mass kg	12 weeks