Clinical trial NCT02094781: Effect of Using Whey Protein and Creatine Supplements on Muscular Strength in Weight-training Adult Males
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nutritional Status
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-03-24
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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

Primary outcomes:
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.
timeFrame: Baseline, Week 2, 4, 8 and 12
Secondary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: