Low Bone Mass
Conditions
Keywords
Resveratrol, Bone Health, Women Health
Brief summary
The purpose of this study is to examine whether daily supplementation of resveratrol would improve bone health in postmenopausal women.
Detailed description
We plan to enroll and screen 68 women, with an estimated 34 qualifying women will be randomly assigned to two groups: 1) the placebo group and 2) the resveratrol group. The resveratrol group will receive 500 mg resveratrol daily for 24 weeks, and placebo group will receive placebo pills. Both groups will receive 500 mg calcium plus 400 IU vitamin D daily. Blood and urinary biomarkers of bone metabolism will be assessed at baseline and after 12 and 24 weeks intervention. Bone mineral density will be assessed using dual-energy X-ray absorptiometry at baseline and after 24 weeks.
Interventions
DIETARY_SUPPLEMENTResveratrol
Resveratrol (500 mg)
DIETARY_SUPPLEMENTPlacebo
Placebo (500 mg)
Sponsors
University of Delaware
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
1 to 10 years postmenopausal women with low bone mass
Exclusion criteria
* Osteoporosis * Taking blood thinners, endocrine, or neuroactive drugs * Hormone therapy * Diagnosed: Metabolic bone disease, renal disease, kidney stones, cancer, cardiovascular disease, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease * Severe menopausal symptoms, serious mood alterations, sleep disturbances * Abnormal uterine bleeding, endometriosis, pelvic inflammatory disease * Endometrial polyps, and significant uterine fibroids * Smokers (≥ 20 cigarettes per day) * BMI \<20 and \> 30 kg/m2 * Intolerance or allergic reaction to resveratrol, microcrystalline cellulose, grapes, red wine, or blueberries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone biomarker | Bone marker will be assessed before and after 12 weeks and 24 weeks intervention | 25-hydroxy vitamin D3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density | Bone mineral density will be assessed before and after 24 weeks intervention | Lumbar spine, hip, forearm, and whole-body bone mineral density and bone mineral content |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSheau Ching Chai, PhD, RD
University of Delaware
Outcome results
None listed