Resveratrol for the Prevention of Bone Loss in Postmenopausal Women

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

Study Overview

• Status: Completed
• Conditions: Low Bone Mass
• Intervention / Treatment: Dietary supplement: Resveratrol; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19716
      • University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resveratrol; Dietary Supplement: Resveratrol (500 mg) + 500 mg calcium and 400 IU vitamin D3	Dietary supplement: Resveratrol; Resveratrol (500 mg)
Placebo Comparator: Placebo; Dietary Supplement: Placebo (500 mg) + 500 mg calcium and 400 IU vitamin D3	Dietary supplement: Placebo; Placebo (500 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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
Bone biomarker	Osteocalcin	Bone marker will be assessed before and after 12 weeks and 24 weeks intervention

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Delaware
• Collaborators: National Institutes of Health (NIH); National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Sheau Ching Chai, PhD, RD, University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Resveratrol; Bone Health; Women Health
• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Stilbenes; Benzylidene Compounds; Stilbestrols; Polyphenols; Resveratrol
• Other Study ID Numbers: 2043372; U54GM104941 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No