Last updated: 11/03/2018 20:54:09
Effect of using whey protein and creatine supplements on muscular strength in weight-training adult males
GSK study ID
200616
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: Baseline, Week 2, 4, 8 and 12
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
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: Baseline and Week 12
Interventions:
Dietary supplement: Whey protein and creatine supplement
Dietary supplement: Whey protein only supplement
Dietary supplement: Placebo
Enrollment:
18
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Nutritional status
Product
GSK3129094
Collaborators
Not applicable
Study date(s)
December 2013 to September 2014
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 35 years
Accepts healthy volunteers
Yes
- Recreationally active males
- Age 18 to 35 years
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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 location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2014-30-09
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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