Resveratrol for the Prevention of Bone Loss in Postmenopausal Women

University of Delaware

Status: Active, not recruiting

Conditions: Low Bone Mass

Treatments: Dietary Supplement: Resveratrol; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06250283

2043372

U54GM104941 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to examine whether daily supplementation of resveratrol would improve bone health in postmenopausal women.

Full 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.

Enrollment: 68 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

Resveratrol

Experimental group

Description:

Dietary Supplement: Resveratrol (500 mg) + 500 mg calcium and 400 IU vitamin D3

Treatment:

Dietary Supplement: Resveratrol

Placebo

Placebo Comparator group

Description:

Dietary Supplement: Placebo (500 mg) + 500 mg calcium and 400 IU vitamin D3

Treatment:

Dietary Supplement: Placebo