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van CCT (UK)

van CCT (UK)

Protein and endurance exercise

- candidate number27829
- NTR NumberNTR6691
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-sep-2017
- Secondary IDsNL60980.072.17 METC Independent Review Board Nijmegen
- Public TitleProtein and endurance exercise
- Scientific TitleProtein supplementation to augment the training adaptations to endurance exercise training.
- hypothesisDaily protein supplementation during long-term endurance exercise training augments the physiological adaptations to endurance exercise training.
- Healt Condition(s) or Problem(s) studiedEndurance exercise, Protein supplementation
- Inclusion criteria Male
Age 18 and 40 years
BMI < 30 kg/m2
Untrained or recreationally active (i.e. performing sport activities on a non-competitive basis for a maximal duration of 6 hours per week).
VO2max ≤ 55 ml●kg-1●min-1
- Exclusion criteria Currently smoking
Lactose intolerance and/or dairy protein allergy
Severe allergy to nuts or intolerance to gluten, as supplements are produced in factory that may have used nuts or gluten previously
Consumption of >21 alcoholic beverages per week
Use of illicit drugs
Use of antibiotics in the past month
Medical condition that can interfere with the study outcome (i.e. cardiovascular disease, pulmonary disease, rheumatoid arthritis, orthopedic disorders, renal disease, liver disease, diabetes mellitus, inflammatory disease, cognitive impairment)
Use of medications known to interfere with selected outcome measures (i.e. statins, fenofibrate, beta-blocker, corticosteroids)
(Chronic) injuries of the locomotor system that can interfere with the intervention.
Current participation in other biomedical research study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 4-sep-2017
- planned closingdate4-sep-2018
- Target number of participants60
- InterventionsExercise training: During the 12-week exercise training program participants will complete three exercise sessions weekly. In the training programs continuous endurance exercise sessions will be alternated with interval exercise sessions.
Protein supplementation: All participants will be randomly assigned to the protein or placebo (isocaloric carbohydrate) group. The protein or placebo supplements will be ingested after each training session and each day before sleep.
- Primary outcomeVO2max (indirect calorimetry)
- Secondary outcomeendurance performance (10-km time trial)
muscle function (isokinetic dynamometry)haematological and biochemical variables (blood)
body composition (dual x ray absorptiometry)
habitual food intake (repeated 24-h recalls)
habitual physical activity (wrist worn accelerometer)
- TimepointsBaseline and following 12 weeks of exercise training.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator HAN University of Applied Sciences
- Funding
(Source(s) of Monetary or Material Support)
Friesland Campina
- Publications
- Brief summaryThe maximal uptake and utilization of oxygen (VO2max) is fundamental to endurance exercise performance. The VO2max can be increased by long-term endurance exercise training. Recent research suggested that the impact of endurance exercise on VO2max can be augmented by the supplementation of protein during long-term endurance exercise training programs. The current study aims to assess the impact protein supplementation during long-term endurance exercise training on VO2max, endurance exercise performance, and muscle function in recreationally active young men. This is a double blind, randomized, placebo-controlled intervention trial. The study involves 12 weeks of endurance exercise training with pre- and post-measurements of exercise capacity and performance. During the 12-week exercise training programs, participants will be randomly assigned to a protein or placebo supplement group.
- Main changes (audit trail)
- RECORD7-sep-2017 - 21-sep-2017

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