NCT06250283

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

February 2, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

March 10, 2026

Status Verified

October 1, 2024

Enrollment Period

1.7 years

First QC Date

January 18, 2024

Last Update Submit

March 6, 2026

Conditions

Low Bone Mass

Keywords

ResveratrolBone HealthWomen Health

Outcome Measures

Primary Outcomes (5)

  • 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

    Osteocalcin

    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

Secondary Outcomes (1)

  • Bone mineral density

    Bone mineral density will be assessed before and after 24 weeks intervention

Study Arms (2)

Resveratrol

EXPERIMENTAL

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

Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

ResveratrolDIETARY_SUPPLEMENT

Resveratrol (500 mg)

Resveratrol
PlaceboDIETARY_SUPPLEMENT

Placebo (500 mg)

Placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • to 10 years postmenopausal women with low bone mass

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Sheau Ching Chai, PhD, RD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2024

First Posted

February 9, 2024

Study Start

February 2, 2024

Primary Completion

October 30, 2025

Study Completion

January 30, 2026

Last Updated

March 10, 2026

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)