Osteoporosis RiskNCT04785131
Prune Consumption and Bone Health in Young Women Using Hormonal Contraceptives
A study testing Prune in people with Osteoporosis Risk, run by San Diego State University at 2 sites in United States.
Trial summary
The primary objective of this study is to determine if 12 months of consuming 50 grams of dried plum daily will prevent bone loss or augment bone accrual of young adult oral contraceptive (OC) users. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis Risk
- What is being tested?
- Prune
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2019to 30 Dec 2024
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-25
Who cannot join
- Metabolic bone disease, renal disease, cancer, CVD, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases, heavy smoking (more than twenty cigarettes/day) and current use of any prescription medications known to alter bone and calcium metabolism
- Regularly consumed dried plum or prune juice
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shirin Hooshmand
San Diego, California, 92182-7251
School of Exercise and Nutritional Sciences
San Diego, California, 92182
About this study
Official title: The Impact of Consuming California Dried Plums on Bone Health of Young Women Using Hormonal Contraceptives
The primary objective of this study is to determine if 12 months of consuming 50 grams of dried plum daily will prevent bone loss or augment bone accrual of young adult oral contraceptive (OC) users.
Read the detailed description
Eligible participants will be assigned among three groups 1) control non-OC users, 2) control OC users, and 3) dried plum OC users. OC users will be randomly allocated to the dried plum OC group, which will consume 50 g dried plum daily for 12 months, or a control group, for which dried plums will not be allowed and no control food will be provided.
- Conditions
- Osteoporosis Risk
- Being tested
- Prune
- Keywords
- Prune, Bone health, Oral contraceptives, Women health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PruneOther
daily consumption of 50 grams prune.
| Study group | Role | What they receive |
|---|---|---|
| Prune group | Experimental | Oral contraceptive users will consume 50 grams prunes daily. Receives: Other: Prune |
| Oral contraceptive users | No intervention | Oral contraceptive users will be monitored throughout the study period. |
| Non oral contraceptive users | No intervention | Non oral contraceptive users will be monitored throughout the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone mineral density from baseline to 12 months
Bone density measurements with DXA
Measured: At baseline, at 12 months
Secondary outcomes (1)
Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months
Bone biomarkers measurements with ELISA
Measured: At baseline, at 6 months, at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start30 Nov 2019
- Primary completion30 Oct 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis RiskStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirin Hooshmand, San Diego State University
- Investigators
- Shirin Hooshmand, PhD, RD, Study director, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785131
- Sponsor's protocol ID
- 59871A
- Status last verified
- Dec 2024
- First submitted
- 3 Mar 2021
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
DeMasi T, Tsang M, Mueller J, Giltvedt K, Nguyen TN, Kern M, Hooshmand S. Prunes May Blunt Adverse Effects of Oral Contraceptives on Bone Health in Young Adult Women: A Randomized Clinical Trial. Curr Dev Nutr. 2024 Jul 18;8(9):104417. doi: 10.1016/j.cdnut.2024.104417. eCollection 2024 Sep.
PubMed 39310666
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Consuming California Dried Plums on Bone Health of Young Women Using Hormonal Contraceptives
- ClinicalTrials.gov ID
- NCT04785131
- Acronym / sponsor ID
- 59871A
- Conditions
- Osteoporosis Risk
- Keywords
- Prune, Bone health, Oral contraceptives, Women health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 5 Mar 2021 (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 primary objective of this study is to determine if 12 months of consuming 50 grams of dried plum daily will prevent bone loss or augment bone accrual of young adult oral contraceptive (OC) users.
Detailed description
Eligible participants will be assigned among three groups 1) control non-OC users, 2) control OC users, and 3) dried plum OC users. OC users will be randomly allocated to the dried plum OC group, which will consume 50 g dried plum daily for 12 months, or a control group, for which dried plums will not be allowed and no control food will be provided.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prune group | Experimental | Other: PruneOral contraceptive users will consume 50 grams prunes daily. |
| Oral contraceptive users | No intervention | –Oral contraceptive users will be monitored throughout the study period. |
| Non oral contraceptive users | No intervention | –Non oral contraceptive users will be monitored throughout the study period. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18-25
Key exclusion criteria (2 listed)
- Metabolic bone disease, renal disease, cancer, CVD, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases, heavy smoking (more than twenty cigarettes/day) and current use of any prescription medications known to alter bone and calcium metabolism
- Regularly consumed 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 |
|---|---|---|
| Prunedaily consumption of 50 grams prune. | Other | Prune group |
Primary outcome
Changes in bone mineral density from baseline to 12 months
Time frame: At baseline, at 12 months
Bone density measurements with DXA
1 secondary outcome
Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months
Time frame: At baseline, at 6 months, at 12 months
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 8 Jan 2025.
- Derived from this study: PubMed 39310666DeMasi T, Tsang M, Mueller J, Giltvedt K, Nguyen TN, Kern M, Hooshmand S. Prunes May Blunt Adverse Effects of Oral Contraceptives on Bone Health in Young Adult Women: A Randomized Clinical Trial. Curr Dev Nutr. 2024 Jul 18;8(9):104417. doi: 10.1016/j.cdnut.2024.104417. eCollection 2024 Sep.
Related trials for Osteoporosis Risk
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
RecruitingObservational study
REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction
Osteoporosis Diagnosis, Bone Health
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
RecruitingPhase 2
Effect of Acetylcholinesterase Inhibitors on Bone Metabolism
Osteoporosis
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.
Shirin Hooshmand, PhD, RD study director
San Diego State University
2 sites 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 Osteoporosis Risk, run by San Diego State University at 2 sites 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 2 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 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Changes in bone mineral density from baseline to 12 months (time frame: At baseline, at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04785131, which also lists 1 linked publication.
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 8 Jan 2025.