Postmenopausal Women
Conditions
Keywords
creatine supplementation, bone mass, postmenopausal women, muscle function, bone markers
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCreatine supplementation
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.
DIETARY_SUPPLEMENTdextrose (placebo)
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.
Sponsors
AlzChem AG
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy postmenopausal women * T-score at lumbar spine, or femoral neck or total femur of between -1SD and -2.5SD
Exclusion criteria
* drugs or dietary supplements that may affect bone metabolism (e.g., bisphosphonates, AINEs, hormone replacement therapy, calcium, vitamin D, creatine supplementation) * low BMI (\< 18.5 Kg/m2).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bone mineral density (BMD) | 12 and 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| history of falls | 24 months | — |
| bone microarchitecture | 12 and 24 months | — |
| bone markers | 12 and 24 months | will include CTX and P1NP |
| lean mass | 12 and 24 months | — |
| laboratory parameters | 12 and 24 months | — |
| muscle function | 12 and 24 months | — |
Countries
Brazil
Contacts
Primary ContactBruno Gualano, PhD
Outcome results
None listed