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Completed

NCT Number: NCT02094781

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.

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Key information

Conditions

Nutritional Status

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey protein and creatine supplement

Dietary 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

Dietary 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

Dietary 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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Body strength will be evaluated using 1-RM and bench and leg press exercise testing

  2. 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

    Body strength will be evaluated using 1-RM and bench and leg press exercise testing

  3. 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

    Body strength will be evaluated using 1-RM and bench and leg press exercise testing

  4. 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

    Body endurance will be measured using bench press and leg press exercise testing

  5. 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

    Body composition [(fat-free mass and fat mass (grams and % body fat, bone mass)] will be calculated using Dual X-Ray Absorptiometry (DXA)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 24, 2014
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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