Nutritional StatusPhase 1NCT02094781
Effect of Using Whey Protein and Creatine Supplements on Muscular Strength in Weight-training Adult Males
A Phase 1 study testing Whey protein and creatine supplement and Whey protein only supplement in people with Nutritional Status, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this study was to evaluate the effect of combined whey protein and creatine supplement, as compared with whey protein supplement alone, on change in upper and lower body strength. 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
- Nutritional Status
- What is being tested?
- Whey protein and creatine supplement and Whey protein only supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Sep 2014
- Phase
- Phase 1
- 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
- Recreationally active males
- Age 18 to 35 years
- BMI 19 to 29.9 kg/m2
- Weight training 3 to 4 times a week for at least 6 months before the trial
Who cannot join
- Participants with medical conditions including active heart disease, high blood pressure, renal or hepatic impairment type I or II diabetes, bipolar disease, pulmonary disease, thyroid disease, immune disorder, psychiatric disorder
- Dietary or herbal supplement used in the past 60 days to increase muscle mass
- Use of protein supplement in the past 7 days
- Use of thermogenic supplement or beverage in the past 7 days
- Use of Non-steroidal anti inflammatory drugs or corticosteroids in the past 7 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Three-arm Trial to Evaluate the Effect of Using Whey Protein and Creatine Supplements on Muscular Strength in Weight-training Adult Males
The purpose of this study was to evaluate the effect of combined whey protein and creatine supplement, as compared with whey protein supplement alone, on change in upper and lower body strength.
- Conditions
- Nutritional Status
- Being tested
- Whey protein and creatine supplement, Whey protein only supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein and creatine supplementDietary supplement
Each sachet contained 30g whey protein powder and 5g creatine powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day
Whey protein only supplementDietary supplement
Each sachet contained 30g of whey protein powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day
PlaceboDietary supplement
Each sachet contained 30g of isocaloric carbohydrate powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day
| Study group | Role | What they receive |
|---|---|---|
| Whey protein and creatine supplement | Experimental | Each sachet contained 30g whey protein powder and 5g creatine powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day Receives: Dietary Supplement: Whey protein and creatine supplement |
| Whey protein only supplement | Active comparator | Each sachet contained 30g of whey protein powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day Receives: Dietary Supplement: Whey protein only supplement |
| Placebo | Placebo comparator | Each sachet contained 30g of isocaloric carbohydrate powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of combined whey protein and creatine supplement, as compared with whey protein supplement alone, on change in upper body strength from Baseline to Week 4.
Body strength will be evaluated using Repetition maximum (1-RM) and bench and leg press exercise testing. 1-RM in weight training is the maximum amount of weight one can lift in a single repetition for a given exercise
Measured: Baseline, Week 2, 4, 8 and 12
Secondary outcomes (5)
To evaluate the effect of combined whey protein and creatine supplement, as compared with whey protein supplement alone, on changes in upper and lower body strength from Baseline through Week 12
Body strength will be evaluated using 1-RM and bench and leg press exercise testing
Measured: Baseline, Week 2, 4, 8 and 12
To evaluate the effect of combined whey protein and creatine supplement, as compared with placebo, on changes in upper and lower body strength from Baseline through Week 12.
Body strength will be evaluated using 1-RM and bench and leg press exercise testing
Measured: Baseline, Week 2, 4, 8 and 12
To compare changes in upper and lower body strength from Baseline through Week 12, between combined whey protein and creatine supplement, whey protein supplement alone, and placebo.
Body strength will be evaluated using 1-RM and bench and leg press exercise testing
Measured: Baseline, Week 2, 4, 8 and 12
To compare changes in upper and lower body endurance from Baseline through Week 12, between combined whey protein and creatine supplement, whey protein supplement alone, and placebo.
Body endurance will be measured using bench press and leg press exercise testing
Measured: Baseline, Week 2, 4, 8 and 12
To compare the changes in lean vs. fat body mass composition from Baseline to Week 12 between combined whey protein and creatine supplement, whey protein supplement alone, and placebo.
Body composition [(fat-free mass and fat mass (grams and % body fat, bone mass)] will be calculated using Dual X-Ray Absorptiometry (DXA)
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 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
- NCT02094781
- Sponsor's protocol ID
- 200616
- Other IDs
- RH01717
- Status last verified
- Dec 2014
- First submitted
- 27 Feb 2014
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Three-arm Trial to Evaluate the Effect of Using Whey Protein and Creatine Supplements on Muscular Strength in Weight-training Adult Males
- ClinicalTrials.gov ID
- NCT02094781
- Acronym / sponsor ID
- 200616
- Conditions
- Nutritional Status
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Mar 2014 (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.
The purpose of this study was to evaluate the effect of combined whey protein and creatine supplement, as compared with whey protein supplement alone, on change in upper and lower body strength.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whey protein and creatine supplement | Experimental | Dietary Supplement: Whey protein and creatine supplementEach sachet contained 30g whey protein powder and 5g creatine powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day |
| Whey protein only supplement | Active comparator | Dietary Supplement: Whey protein only supplementEach sachet contained 30g of whey protein powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboEach sachet contained 30g of isocaloric carbohydrate powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Recreationally active males
- Age 18 to 35 years
- BMI 19 to 29.9 kg/m2
- Weight training 3 to 4 times a week for at least 6 months before the trial
Key exclusion criteria (5 listed)
- Participants with medical conditions including active heart disease, high blood pressure, renal or hepatic impairment type I or II diabetes, bipolar disease, pulmonary disease, thyroid disease, immune disorder, psychiatric disorder
- Dietary or herbal supplement used in the past 60 days to increase muscle mass
- Use of protein supplement in the past 7 days
- Use of thermogenic supplement or beverage in the past 7 days
- Use of Non-steroidal anti inflammatory drugs or corticosteroids in the past 7 days
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 |
|---|---|---|
| Whey protein and creatine supplementEach sachet contained 30g whey protein powder and 5g creatine powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day | Dietary supplement | Whey protein and creatine supplement |
| Whey protein only supplementEach sachet contained 30g of whey protein powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day | Dietary supplement | Whey protein only supplement |
| PlaceboEach sachet contained 30g of isocaloric carbohydrate powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day | Dietary supplement | Placebo |
Primary outcome
To evaluate the effect of combined whey protein and creatine supplement, as compared with whey protein supplement alone, on change in upper body strength from Baseline to Week 4.
Time frame: Baseline, Week 2, 4, 8 and 12
Body strength will be evaluated using Repetition maximum (1-RM) and bench and leg press exercise testing. 1-RM in weight training is the maximum amount of weight one can lift in a single repetition for a given exercise
5 secondary outcomes
To evaluate the effect of combined whey protein and creatine supplement, as compared with whey protein supplement alone, on changes in upper and lower body strength from Baseline through Week 12
Time frame: Baseline, Week 2, 4, 8 and 12
To evaluate the effect of combined whey protein and creatine supplement, as compared with placebo, on changes in upper and lower body strength from Baseline through Week 12.
Time frame: Baseline, Week 2, 4, 8 and 12
To compare changes in upper and lower body strength from Baseline through Week 12, between combined whey protein and creatine supplement, whey protein supplement alone, and placebo.
Time frame: Baseline, Week 2, 4, 8 and 12
To compare changes in upper and lower body endurance from Baseline through Week 12, between combined whey protein and creatine supplement, whey protein supplement alone, and placebo.
Time frame: Baseline, Week 2, 4, 8 and 12
To compare the changes in lean vs. fat body mass composition from Baseline to Week 12 between combined whey protein and creatine supplement, whey protein supplement alone, and placebo.
Time frame: Baseline and Week 12
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 Dec 2014.
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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 Phase 1 study testing Whey protein and creatine supplement and Whey protein only supplement in people with Nutritional Status, run by GlaxoSmithKline at 1 site in United States.
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 Dec 2014. 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 States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To evaluate the effect of combined whey protein and creatine supplement, as compared with whey protein supplement alone, on change in upper body strength from Baseline to Week 4. (time frame: Baseline, Week 2, 4, 8 and 12). 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 Dec 2014.