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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM104941 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The purpose of this study is to examine whether daily supplementation of resveratrol would improve bone health in postmenopausal women.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: Resveratrol (500 mg) + 500 mg calcium and 400 IU vitamin D3 |
|
| Placebo | Placebo Comparator | Dietary Supplement: Placebo (500 mg) + 500 mg calcium and 400 IU vitamin D3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Dietary Supplement | Resveratrol (500 mg) |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Bone biomarker | 25-hydroxy vitamin D3 | Bone marker will be assessed before and after 12 weeks and 24 weeks intervention |
| Bone biomarker | Alkaline phosphatase | Bone marker will be assessed before and after 12 weeks and 24 weeks intervention |
| Bone biomarker | Osteocalcin | Bone marker will be assessed before and after 12 weeks and 24 weeks intervention |
| Bone biomarker | Deoxypyridinoline | Bone marker will be assessed before and after 12 weeks and 24 weeks intervention |
| Bone biomarker | C-terminal telopeptide type I collagen | Bone marker will be assessed before and after 12 weeks and 24 weeks intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density | Lumbar spine, hip, forearm, and whole-body bone mineral density and bone mineral content | Bone mineral density will be assessed before and after 24 weeks intervention |
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Inclusion Criteria:
1 to 10 years postmenopausal women with low bone mass
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheau Ching Chai, PhD, RD | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19716 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 31, 2025 | May 7, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Dietary Supplement |
Placebo (500 mg) |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |