Low Bone MassNCT06250283
Resveratrol for the Prevention of Bone Loss in Postmenopausal Women
A study testing Resveratrol in people with Low Bone Mass, run by University of Delaware at 1 site in United States.
Trial summary
The purpose of this study is to examine whether daily supplementation of resveratrol would improve bone health in postmenopausal women. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Bone Mass
- What is being tested?
- Resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1 to 10 years postmenopausal women with low bone mass
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine whether daily supplementation of resveratrol would improve bone health in postmenopausal women.
Read the 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.
- Conditions
- Low Bone Mass
- Being tested
- Resveratrol, Placebo
- Keywords
- Resveratrol, Bone Health, Women Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
Resveratrol (500 mg)
PlaceboDietary supplement
Placebo (500 mg)
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: Resveratrol (500 mg) + 500 mg calcium and 400 IU vitamin D3 Receives: Dietary Supplement: Resveratrol |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (500 mg) + 500 mg calcium and 400 IU vitamin D3 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone biomarker
25-hydroxy vitamin D3
Measured: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Bone biomarker
Alkaline phosphatase
Measured: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Bone biomarker
Osteocalcin
Measured: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Bone biomarker
Deoxypyridinoline
Measured: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Bone biomarker
C-terminal telopeptide type I collagen
Measured: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Secondary outcomes (1)
Bone mineral density
Lumbar spine, hip, forearm, and whole-body bone mineral density and bone mineral content
Measured: Bone mineral density will be assessed before and after 24 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start2 Feb 2024
- Primary completion30 Oct 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Bone MassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Sheau Ching Chai, PhD, RD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250283
- Sponsor's protocol ID
- 2043372
- Other IDs
- U54GM104941
- Status last verified
- Oct 2024
- First submitted
- 18 Jan 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resveratrol for the Prevention of Bone Loss in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06250283
- Acronym / sponsor ID
- 2043372
- Conditions
- Low Bone Mass
- Keywords
- Resveratrol, Bone Health, Women Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: ResveratrolDietary Supplement: Resveratrol (500 mg) + 500 mg calcium and 400 IU vitamin D3 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary Supplement: Placebo (500 mg) + 500 mg calcium and 400 IU vitamin D3 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1 to 10 years postmenopausal women with low bone mass
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResveratrolResveratrol (500 mg) | Dietary supplement | Resveratrol |
| PlaceboPlacebo (500 mg) | Dietary supplement | Placebo |
Primary outcome
Bone biomarker
Time frame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
25-hydroxy vitamin D3
Bone biomarker
Time frame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Alkaline phosphatase
Bone biomarker
Time frame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Osteocalcin
Bone biomarker
Time frame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
Deoxypyridinoline
Bone biomarker
Time frame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
C-terminal telopeptide type I collagen
1 secondary outcome
Bone mineral density
Time frame: Bone mineral density will be assessed before and after 24 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
Related trials for Low Bone Mass
Not yet recruitingPhase 2
Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass
Postmenopausal Osteoporosis, Low Bone Mass
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheau Ching Chai, PhD, RD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol in people with Low Bone Mass, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone biomarker (time frame: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.