Bone Disease, MetabolicNCT06184646
Elucidating the Minimal Effective Dose of Prunes for Bone Health in Postmenopausal Women
A study testing Prune in people with Bone Disease, Metabolic, run by San Diego State University at 1 site in United States.
Trial summary
The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Bone Disease, Metabolic
- What is being tested?
- Prune
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal
- BMD t-score is between 0.5 and 2 SD below the mean
- Not on hormone replacement therapy (HRT) and/or other pharmacological agents known to affect bone for at least three months prior to initiation of the study
Who cannot join
- Women whose BMD t-score at any site falls below 2.5 SD of the mean
- Subjects receiving endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
- Subjects who smoke cigarettes or vape
- Regular consumption of dried plum or prune juice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Diego State University
San Diego, California, 92182-7251
Shirin Hooshmand, PhD, RD
About this study
Official title: Effect of Calcium and Vitamin D Supplements and/or Prunes on Bone Health
The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.
Read the detailed description
Two hundred randomly assigned to one of two treatment groups: 1) 30 g prunes and 2) control (0 g prunes). Both groups received 500 mg calcium and 400 IU Vitamin D as a daily supplement. Blood samples are collected at baseline, 12 and 24 months to assess biomarkers of bone turnover. Physical activity recall and food records are obtained at baseline, 12 and 24 months to examine physical activity and dietary confounders as potential covariates. Dual-energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) will be completed at baseline, 12 and 24 months to examine bone mineral density and structure.
- Conditions
- Bone Disease, Metabolic
- Being tested
- Prune
- Keywords
- Osteopenia, Prune, Functional food
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PruneDietary supplement
30 g of prune/day
| Study group | Role | What they receive |
|---|---|---|
| Control (0 g prune/day) | No intervention | Participants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months. |
| 30 g prune/day | Experimental | Participants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months. Receives: Dietary Supplement: Prune |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in bone mineral density at 12 and 24 months
bone mineral density as assessed by dual energy x-ray absorptiometry
Measured: Baseline, 12 months, and 24 months
Secondary outcomes (2)
Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months
bone specific alkaline phosphatase (BAP) as assessed with ELISA
Measured: Baseline, 12 months, and 24 months
Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months
tartrate acid phosphatase-5b (TRAP5b) as assessed with ELISA
Measured: Baseline, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start15 Mar 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Disease, MetabolicStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shirin Hooshmand, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184646
- Sponsor's protocol ID
- HS-2023-0243
- Status last verified
- Jun 2026
- First submitted
- 14 Dec 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium and Vitamin D Supplements and/or Prunes on Bone Health
- ClinicalTrials.gov ID
- NCT06184646
- Acronym / sponsor ID
- HS-2023-0243
- Conditions
- Bone Disease, Metabolic
- Keywords
- Osteopenia, Prune, Functional food
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Dec 2023 (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 objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.
Detailed description
Two hundred randomly assigned to one of two treatment groups: 1) 30 g prunes and 2) control (0 g prunes). Both groups received 500 mg calcium and 400 IU Vitamin D as a daily supplement. Blood samples are collected at baseline, 12 and 24 months to assess biomarkers of bone turnover. Physical activity recall and food records are obtained at baseline, 12 and 24 months to examine physical activity and dietary confounders as potential covariates. Dual-energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) will be completed at baseline, 12 and 24 months to examine bone mineral density and structure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (0 g prune/day) | No intervention | –Participants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months. |
| 30 g prune/day | Experimental | Dietary Supplement: PruneParticipants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal
- BMD t-score is between 0.5 and 2 SD below the mean
- Not on hormone replacement therapy (HRT) and/or other pharmacological agents known to affect bone for at least three months prior to initiation of the study
Key exclusion criteria (4 listed)
- Women whose BMD t-score at any site falls below 2.5 SD of the mean
- Subjects receiving endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
- Subjects who smoke cigarettes or vape
- Regular consumption of dried plum or prune juice
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 |
|---|---|---|
| Prune30 g of prune/day | Dietary supplement | 30 g prune/day |
Primary outcome
Changes from baseline in bone mineral density at 12 and 24 months
Time frame: Baseline, 12 months, and 24 months
bone mineral density as assessed by dual energy x-ray absorptiometry
2 secondary outcomes
Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months
Time frame: Baseline, 12 months, and 24 months
Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months
Time frame: Baseline, 12 months, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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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.
Shirin Hooshmand, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prune in people with Bone Disease, Metabolic, run by San Diego State University 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 Jul 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shirin Hooshmand, PhD (619-594-6823, shooshmand@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in bone mineral density at 12 and 24 months (time frame: Baseline, 12 months, and 24 months). 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 1 Jul 2026.