Last updated: 11/03/2018 22:42:41
Efficacy study of protein supplementation in attenuating the decline in performance after strenuous concurrent exercise
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Study to Evaluate the Effects of Protein Supplementation in Attenuating the Decline in Performance Following Strenuous Concurrent Exercise
Trial description: This study is designed to investigate whether protein supplementation can improve recovery of muscle function following a strenuous combination of both endurance and resistance exercise. It will specifically investigate the effect of protein supplementation on the recovery of strength, power and endurance exercise performance, along with measures of damage and inflammation of the muscle.
Primary purpose:
Supportive Care
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Isometric Maximal Voluntary Contraction (MVC) Assessment
Timeframe: 96 hours (h)
Counter Movement Jump (CMJ) Assessment
Timeframe: 96 h
16.1 Kilometer (km) Cycling Time Trial (TT) Assessment
Timeframe: 96 h
Secondary outcomes:
Serum Creatine Kinase Analysis
Timeframe: 96 h
Serum C-Reactive Protein Analysis
Timeframe: 96 h
Perceived Muscle Soreness Assessment
Timeframe: 96 h
Interventions:
Dietary supplement: Test product
Dietary supplement: Reference product 1
Dietary supplement: Reference product 2
Enrollment:
24
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sports Nutritional Sciences
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2015 to February 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Male
Age
18 - 35 years
Accepts healthy volunteers
Yes
- Understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary informed consent form and has received signed and dated copy of the informed consent form
- Male participants; age between 18 to 35 years, inclusive
- Currently taking any nutritional supplements, polyphenols or beta-blockers, Non-steroidal anti-inflammatory drugs (NSAIDs), recreational drugs
- Known or suspected intolerance or hypersensitivity to the study material or any of their stated ingredients
Inclusion and exclusion criteria
Inclusion criteria:
- Understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary informed consent form and has received signed and dated copy of the informed consent form
- Male participants; age between 18 to 35 years, inclusive
- Well trained endurance cyclist (competing at a minimum of Category 3 road-racing/estimated 10 mile TT of <23 minutes), with a training history >1 year
- Good general and mental health
Exclusion criteria:
- Currently taking any nutritional supplements, polyphenols or beta-blockers, Non-steroidal anti-inflammatory drugs (NSAIDs), recreational drugs
- Known or suspected intolerance or hypersensitivity to the study material or any of their stated ingredients
- Allergy to milk or wheat products
- Heart or any other medical condition that may contra-indicate participants from taking part in high intensity or exhaustive physical activity
- Previous participation in this study; another clinical study or receipt of an investigational drug within 30 days of the screening visit; participation in another study involving a protocol to elicit Exercise-Induced Muscle Damage (EIMD) within 6 months of the screening visit
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2016-12-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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