Resveratrol for the Prevention of Bone Loss in Postmenopausal Women

Low Bone Mass Clinical Trial

Official title:

Resveratrol for the Prevention of Bone Loss in Postmenopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250283
• Other study ID #: 2043372
• Secondary ID: U54GM104941
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Delaware
• Contact: Sheau Ching Chai, PhD, RD
• Phone: 302-831-7345
• Email: scchai[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

34 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1 to 5 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

Related Conditions & MeSH terms

• Low Bone Mass

Intervention

Dietary Supplement:
• Resveratrol
Resveratrol (500 mg)
• Placebo
Placebo (500 mg)

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (3)

Lead Sponsor	Collaborator
University of Delaware	National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone biomarker	25-hydroxy vitamin D3	Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Primary	Bone biomarker	Alkaline phosphatase	Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Primary	Bone biomarker	Dsteocalcin,	Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Primary	Bone biomarker	Deoxypyridinoline	Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Primary	Bone biomarker	C-terminal telopeptide type I collagen	Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Secondary	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