Effect of Using Whey Protein and Creatine Supplements on Muscular Strength in Weight-training Adult Males

Phase 1

Completed

• Conditions: Nutritional Status
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Whey protein and creatine supplement; Dietary Supplement: Whey protein only supplement

• Registration Number: NCT02094781
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-24
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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
Whey protein and creatine supplement	Whey protein and creatine 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 supplement	Whey protein only 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

Primary Outcome Measures

Name	Time	Method
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.	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

Secondary Outcome Measures

Name	Time	Method
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.	Baseline, Week 2, 4, 8 and 12	Body strength will be evaluated using 1-RM and bench and leg press exercise testing
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.	Baseline, Week 2, 4, 8 and 12	Body endurance will be measured using bench press and leg press exercise testing
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.	Baseline and Week 12	Body composition \[(fat-free mass and fat mass (grams and % body fat, bone mass)\] will be calculated using Dual X-Ray Absorptiometry (DXA)
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.	Baseline, Week 2, 4, 8 and 12	Body strength will be evaluated using 1-RM and bench and leg press exercise testing
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	Baseline, Week 2, 4, 8 and 12	Body strength will be evaluated using 1-RM and bench and leg press exercise testing

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Miami, Florida, United States