Resveratrol for the Prevention of Bone Loss in Postmenopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-02

Study Completion Date

2026-01-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Low Bone Mass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Resveratrol

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

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DIETARY_SUPPLEMENT

Resveratrol (500 mg)

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (500 mg)

Interventions

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Resveratrol

Resveratrol (500 mg)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (500 mg)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes