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OpenTrials
Completed

NCT Number: NCT06250283

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.

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19716, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Dietary Supplement

Resveratrol (500 mg)

Placebo

Dietary Supplement

Placebo (500 mg)

Primary outcomes

  1. Bone biomarker

    Time frame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention

    25-hydroxy vitamin D3

  2. Bone biomarker

    Time frame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention

    Alkaline phosphatase

  3. Bone biomarker

    Time frame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention

    Osteocalcin

  4. Bone biomarker

    Time frame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention

    Deoxypyridinoline

  5. Bone biomarker

    Time frame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention

    C-terminal telopeptide type I collagen

Secondary outcomes

  1. Bone mineral density

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 9, 2024
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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