Clinical trial NCT06250283: Resveratrol for the Prevention of Bone Loss in Postmenopausal Women
Official title: Resveratrol for the Prevention of Bone Loss in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Bone Mass
Keywords: Resveratrol
Bone Health
Women Health
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2024-02-09
Enrollment: 68
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone biomarker
timeFrame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
measure: Bone biomarker
timeFrame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
measure: Bone biomarker
timeFrame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
measure: Bone biomarker
timeFrame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
measure: Bone biomarker
timeFrame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Secondary outcomes:
measure: Bone mineral density
timeFrame: Bone mineral density will be assessed before and after 24 weeks intervention
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Sheau Ching Chai, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: