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Resistance training combined with protein or amino acids supplementation has been shown to be promising for mitigating age-related disabilities and comorbidities. Randomized controlled trials supporting this possibility are still scarce. These series of clinical trials aim to investigate the chronic effects of different strategies of protein and derivatives supplementation in association with resistance training on selected health-related parameters in pre-frail and frail elderly.This is a 16-month, double-blind, randomized, placebo-controlled, parallel-group clinical trial involving a series of investigations. Participants will be divided into nine groups, allowing the assessement of the effects of (1) isolated leucine supplementation; (2) protein source (whey vs. soy); (3) combination of whey protein and creatine; and (4) sexual dimorphism to the response of protein intake plus resistance training (men vs. women). All participants will undergo a supervised, resistance training program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | alanine as placebo to leucine (same dosage); corn starch as placebo to protein and/or creatine (same dosage) |
|
| whey protein | Experimental |
| |
| soy protein | Experimental |
| |
| leucine supplementation | Experimental |
| |
| whey plus creatine | Experimental |
| |
| creatine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein | Dietary Supplement | 30 g in total; twice a day (morning and evening) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| lean mass | assessed by Dual-energy X-ray absorptiometry | 4 months |
| muscle function | assessed by a battery of physical tests | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| bone mass | assessed by Dual-energy X-ray absorptiometry | 4 months |
| insulin sensitivity | assessed by homeostasis model assessment (HOMA index) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Gualano, Professor | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo | São Paulo | 05508030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34358827 | Derived | Roschel H, Hayashi AP, Fernandes AL, Jambassi-Filho JC, Hevia-Larrain V, de Capitani M, Santana DA, Goncalves LS, de Sa-Pinto AL, Lima FR, Sapienza MT, Duarte AJS, Pereira RMR, Phillips SM, Gualano B. Supplement-based nutritional strategies to tackle frailty: A multifactorial, double-blind, randomized placebo-controlled trial. Clin Nutr. 2021 Aug;40(8):4849-4858. doi: 10.1016/j.clnu.2021.06.024. Epub 2021 Jul 3. | |
| 27224505 |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| D000067796 | Whey |
| D003401 | Creatine |
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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| whey plus creatine |
| Dietary Supplement |
whey protein combined with creatine (30 g and 6.0 g in total; twice a day, respectively) |
|
| leucine supplementation | Dietary Supplement | 7.5 g/d in total; three times per day |
|
| soy protein | Dietary Supplement | 30 g in total; twice a day |
|
| creatine | Dietary Supplement | 6.0 g in total; twice a day |
|
| placebo | Dietary Supplement |
|
| 4 months |
| health related-quality of life | assessed by Short-Form Health Survey (SF-36) (score range: 0 to 100, higher values mean better quality of life) | 4 months |
| Derived |
| Collins J, Longhurst G, Roschel H, Gualano B. Resistance Training and Co-supplementation with Creatine and Protein in Older Subjects with Frailty. J Frailty Aging. 2016;5(2):126-34. doi: 10.14283/jfa.2016.85. |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D001628 | Beverages |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D010940 | Plant Proteins |
| D014674 | Plant Proteins, Dietary |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |