Sports Nutritional SciencesNCT02458599
Efficacy Study of Protein Supplementation in Attenuating the Decline in Performance After Strenuous Concurrent Exercise
A study testing Test product, Reference product 1 and Reference product 2 in people with Sports Nutritional Sciences, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Nutritional Sciences
- What is being tested?
- Test product, Reference product 1 and Reference product 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effects of Protein Supplementation in Attenuating the Decline in Performance Following Strenuous Concurrent Exercise
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.
- Conditions
- Sports Nutritional Sciences
- Being tested
- Test product, Reference product 1, Reference product 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test productDietary supplement
Whey protein hydrolysate (20 g)
Reference product 1Dietary supplement
Iso-energetic carbohydrate (20 g)
Reference product 2Dietary supplement
Negligible energy placebo (20 g)
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | One ready-to-drink beverage of 500 milliliter (mL) volume, containing 20 gram (g) protein will be administered orally, twice daily for four days. Receives: Dietary Supplement: Test product |
| Reference product 1 | Active comparator | One ready-to-drink beverage of 500 mL volume, containing 20 g carbohydrate will be administered orally, twice daily for four days. Receives: Dietary Supplement: Reference product 1 |
| Reference product 2 | Placebo comparator | One ready-to-drink beverage of 500 mL volume, containing 0 g carbohydrate will be administered orally, twice daily for four days. Receives: Dietary Supplement: Reference product 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric Maximal Voluntary Contraction (MVC) Assessment
Maximum voluntary isometric contraction (MVIC) will be assessed at the knee during a leg extension movement using an isokinetic dynamometer. MVIC will be used to assess strength. Participants will perform the exercise using the dominant leg at a knee joint angle of 70º three times, with a contraction of 3 seconds (s) on each occasion (each contraction separated by 60 s rest). The peak force (measured in Newton) generated across the three repetitions will be recorded.
Measured: 96 hours (h)
Counter Movement Jump (CMJ) Assessment
Power will be assessed using counter-movement jump. Participants will place their hands on their hips, descend rapidly to ~90º knee joint angle, and then jump as high as possible using a counter-movement. Three jumps will be performed (each jump separated by 60 s rest) and the peak vertical jump height (measured in centimeters) will be recorded.
Measured: 96 h
16.1 Kilometer (km) Cycling Time Trial (TT) Assessment
The 16.1 km cycling TT assessment will be performed on a cycling ergometer. Participants will be required to complete a distance of 16.1 km in as short a time as possible, while being blinded to time elapsed.
Measured: 96 h
Secondary outcomes (3)
Serum Creatine Kinase Analysis
Muscle damage will be assessed by analyzing serum creatine kinase (CK) using CK N-Acetyl-L Cysteine (NAC)-activated Enzyme Linked Immunosorbent Assay (ELISA).
Measured: 96 h
Serum C-Reactive Protein Analysis
Muscle inflammation will be assessed by analyzing serum high sensitivity (hs) C-reactive protein (CRP) using hs-CRP ELISA.
Measured: 96 h
Perceived Muscle Soreness Assessment
Perceived muscle soreness will be measured on a 200 mm visual analogue scale (VAS) where 0 mm= no pain and 200 mm= unbearably painful. Participants will be required to hold a fixed squat position (90º knee joint angle) while perceived muscle soreness is rated.
Measured: 96 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Nutritional SciencesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458599
- Sponsor's protocol ID
- 204676
- Status last verified
- Aug 2016
- First submitted
- 28 May 2015
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effects of Protein Supplementation in Attenuating the Decline in Performance Following Strenuous Concurrent Exercise
- ClinicalTrials.gov ID
- NCT02458599
- Acronym / sponsor ID
- 204676
- Conditions
- Sports Nutritional Sciences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Dietary Supplement: Test productOne ready-to-drink beverage of 500 milliliter (mL) volume, containing 20 gram (g) protein will be administered orally, twice daily for four days. |
| Reference product 1 | Active comparator | Dietary Supplement: Reference product 1One ready-to-drink beverage of 500 mL volume, containing 20 g carbohydrate will be administered orally, twice daily for four days. |
| Reference product 2 | Placebo comparator | Dietary Supplement: Reference product 2One ready-to-drink beverage of 500 mL volume, containing 0 g carbohydrate will be administered orally, twice daily for four days. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test productWhey protein hydrolysate (20 g) | Dietary supplement | Test product |
| Reference product 1Iso-energetic carbohydrate (20 g) | Dietary supplement | Reference product 1 |
| Reference product 2Negligible energy placebo (20 g) | Dietary supplement | Reference product 2 |
Primary outcome
Isometric Maximal Voluntary Contraction (MVC) Assessment
Time frame: 96 hours (h)
Maximum voluntary isometric contraction (MVIC) will be assessed at the knee during a leg extension movement using an isokinetic dynamometer. MVIC will be used to assess strength. Participants will perform the exercise using the dominant leg at a knee joint angle of 70º three times, with a contraction of 3 seconds (s) on each occasion (each contraction separated by 60 s rest). The peak force (measured in Newton) generated across the three repetitions will be recorded.
Counter Movement Jump (CMJ) Assessment
Time frame: 96 h
Power will be assessed using counter-movement jump. Participants will place their hands on their hips, descend rapidly to ~90º knee joint angle, and then jump as high as possible using a counter-movement. Three jumps will be performed (each jump separated by 60 s rest) and the peak vertical jump height (measured in centimeters) will be recorded.
16.1 Kilometer (km) Cycling Time Trial (TT) Assessment
Time frame: 96 h
The 16.1 km cycling TT assessment will be performed on a cycling ergometer. Participants will be required to complete a distance of 16.1 km in as short a time as possible, while being blinded to time elapsed.
3 secondary outcomes
Serum Creatine Kinase Analysis
Time frame: 96 h
Serum C-Reactive Protein Analysis
Time frame: 96 h
Perceived Muscle Soreness Assessment
Time frame: 96 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product, Reference product 1 and Reference product 2 in people with Sports Nutritional Sciences, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric Maximal Voluntary Contraction (MVC) Assessment (time frame: 96 hours (h)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.