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| Name | Class |
|---|---|
| AlzChem AG | INDUSTRY |
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Animal, in vitro and small-scale studies have suggested that creatine supplementation may augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine supplementation protocol on bone mass in postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Creatine supplementation | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Creatine supplementation | Dietary Supplement | The CR group will receive either 1g or 3g of Cr monohydrate (Creapure®) per day throughout the trial. The dose of creatine will be formulated in a tablet. |
| Measure | Description | Time Frame |
|---|---|---|
| bone mineral density (BMD) | 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| bone markers | will include CTX and P1NP | 12 and 24 months |
| history of falls | 24 months | |
| bone microarchitecture |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Gualano, PhD | Contact | 551130913096 | gualano@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Gualano, PhD | University of Sao Paulo | Principal Investigator |
| Rosa M Pereira, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo - School of Medicine | Recruiting | São Paulo | São Paulo | 01246-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31257405 | Derived | Sales LP, Pinto AJ, Rodrigues SF, Alvarenga JC, Goncalves N, Sampaio-Barros MM, Benatti FB, Gualano B, Rodrigues Pereira RM. Creatine Supplementation (3 g/d) and Bone Health in Older Women: A 2-Year, Randomized, Placebo-Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Apr 17;75(5):931-938. doi: 10.1093/gerona/glz162. | |
| 26192975 |
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| ID | Term |
|---|---|
| D003401 | Creatine |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
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| dextrose (placebo) | Dietary Supplement | The placebo group will be given the same dose of dextrose formulated in a tablet to be consumed under the same conditions. The two types of tablets will not be distinguishable from each other having the same appearance, taste and smell. |
|
| 12 and 24 months |
| muscle function | 12 and 24 months |
| lean mass | 12 and 24 months |
| laboratory parameters | 12 and 24 months |
| Lobo DM, Tritto AC, da Silva LR, de Oliveira PB, Benatti FB, Roschel H, Niess B, Gualano B, Pereira RM. Effects of long-term low-dose dietary creatine supplementation in older women. Exp Gerontol. 2015 Oct;70:97-104. doi: 10.1016/j.exger.2015.07.012. Epub 2015 Jul 17. |
| 24530883 | Derived | Gualano B, Macedo AR, Alves CR, Roschel H, Benatti FB, Takayama L, de Sa Pinto AL, Lima FR, Pereira RM. Creatine supplementation and resistance training in vulnerable older women: a randomized double-blind placebo-controlled clinical trial. Exp Gerontol. 2014 May;53:7-15. doi: 10.1016/j.exger.2014.02.003. Epub 2014 Feb 13. |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |