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| ID | Type | Description | Link |
|---|---|---|---|
| RH01717 | Other Identifier | GSK |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein and creatine supplement | Experimental | 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 |
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| Whey protein only supplement | Active Comparator | 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 | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Miami | Florida | 33143 | United States |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| D003401 | Creatine |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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|
| 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 |
|
| 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 |
| 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 |
| 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 |
| 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 |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |