Resveratrol for the Prevention of Bone Loss in Postmenopausal Women

Not Applicable

Active, not recruiting

• Conditions: Low Bone Mass
• Interventions: Dietary Supplement: Resveratrol; Dietary Supplement: Placebo

• Registration Number: NCT06250283
• Lead Sponsor: University of Delaware

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.

Study Timeline

• Study First Submitted: 2024-01-18
• Study Start: 2024-02-02
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-09
• Status Verified: 2024-10
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-25
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resveratrol	Resveratrol	Dietary Supplement: Resveratrol (500 mg) + 500 mg calcium and 400 IU vitamin D3
Placebo	Placebo	Dietary Supplement: Placebo (500 mg) + 500 mg calcium and 400 IU vitamin D3

Primary Outcome Measures

Name	Time	Method
Bone biomarker	Bone marker will be assessed before and after 12 weeks and 24 weeks intervention	C-terminal telopeptide type I collagen

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Delaware; 🇺🇸 Newark, Delaware, United States