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

Nutritional Status Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094781
• Other study ID #: 200616
• Secondary ID: RH01717
• Status: Completed
• Phase: Phase 1
• First received: February 27, 2014
• Last updated: December 11, 2014
• Start date: December 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Nutritional Status

Intervention

Dietary 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
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
• 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

Locations

Country	Name	City	State
United States	GSK Investigational Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, Week 2, 4, 8 and 12	No
Secondary	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	Baseline, Week 2, 4, 8 and 12	No
Secondary	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	Baseline, Week 2, 4, 8 and 12	No
Secondary	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	Baseline, Week 2, 4, 8 and 12	No
Secondary	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	Baseline, Week 2, 4, 8 and 12	No
Secondary	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)	Baseline and Week 12	No