OsteoporosisNCT04720833
Effect of Dried Plum on Bone and Markers of Bone Status in Men
A study testing dried plum and Calcium and vitamin D in people with Osteoporosis and Osteopenia, run by San Diego State University at 1 site in United States.
Trial summary
The principal objective of this study is to examine whether the addition of 100 g dried plum to the diets of men, regardless of their bone status, positively influences their indices of bone turnover in comparison with their corresponding baseline values and the control regimen. Read more about this study
- Who is it for?
- Ages 50 to 79 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- dried plum and Calcium and vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2016to 15 Dec 2019
- 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 50 to 79 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men (50-79 year-old)
Who cannot join
- endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
- Men whose BMD t-score at any site falls below 2.5 SD of the mean will be excluded from the study and referred to their primary care physician
- subjects treated with calcitonin, bisphosphonates, raloxifene, sodium fluoride, anabolic agents, e.g. PTH and growth hormone, or steroids for less than 3 months prior to the start of the study will be excluded.
- body mass index (BMI) <18 and >30 will be excluded to avoid extremes in leanness/adiposity and to readily allow body composition assessment.
- If subjects smoke 20 cigarettes or more per day, they will be excluded.
- Men who regularly consume dried plum or prune juice will not be accepted into the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Exercise and Nutritional Sciences
San Diego, California, 92182
About this study
The principal objective of this study is to examine whether the addition of 100 g dried plum to the diets of men, regardless of their bone status, positively influences their indices of bone turnover in comparison with their corresponding baseline values and the control regimen.
Read the detailed description
To test the bone protective properties of dried plum, 66 men (50 to 79 years of age) will receive either 100 g dried plum/day or a control regimen for 12 months. Both groups will receive 500 mg calcium and 400 IU vitamin D daily.
Evaluation will be based on analyses of bone mineral density at baseline, 6 and 12-months and serum and urine markers of bone formation and resorption at baseline and 3, 6, and 12-months.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- dried plum, Calcium and vitamin D
- Keywords
- Prunes, dried plum, nutrition, bone
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dried plumDietary supplement
Dried plum
Calcium and vitamin DDietary supplement
Calcium and vitamin D supplement
| Study group | Role | What they receive |
|---|---|---|
| dried plum (100 g dried plum) | Experimental | Participants will receive 100 g dried plum daily plus 500 mg calcium and 300 IU vitamin D daily Receives: Dietary Supplement: dried plum |
| Calcium and vitamin D | Placebo comparator | Participants will receive 500 mg calcium and 300 IU vitamin D daily Receives: Dietary Supplement: Calcium and vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone biomarkers
TRAP5b, BAP, CTX, P1NP
Measured: changes from baseline to 3 months
Secondary outcomes (1)
Bone mineral density
BMD by DXA
Measured: changes from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start16 Sep 2016
- Primary completion10 Sep 2019
- Study completion15 Dec 2019
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 OsteoporosisStudies 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
- Model description
- Subjects will be randomly assign to one of the arms.
- Masking
- None (open label)
- Enrolment
- 66 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, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720833
- Sponsor's protocol ID
- 2521098
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hooshmand S, Gaffen D, Eisner A, Fajardo J, Payton M, Kern M. Effects of 12 Months Consumption of 100 g Dried Plum (Prunes) on Bone Biomarkers, Density, and Strength in Men. J Med Food. 2022 Jan;25(1):40-47. doi: 10.1089/jmf.2021.0080. Epub 2021 Oct 29.
PubMed 34714130
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dried Plum on Bone and Markers of Bone Status in Men
- ClinicalTrials.gov ID
- NCT04720833
- Acronym / sponsor ID
- 2521098
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- Prunes, dried plum, nutrition, bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 16 Sep 2016 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 22 Jan 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 principal objective of this study is to examine whether the addition of 100 g dried plum to the diets of men, regardless of their bone status, positively influences their indices of bone turnover in comparison with their corresponding baseline values and the control regimen.
Detailed description
To test the bone protective properties of dried plum, 66 men (50 to 79 years of age) will receive either 100 g dried plum/day or a control regimen for 12 months. Both groups will receive 500 mg calcium and 400 IU vitamin D daily.
Evaluation will be based on analyses of bone mineral density at baseline, 6 and 12-months and serum and urine markers of bone formation and resorption at baseline and 3, 6, and 12-months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly assign to one of the arms.
| Arm | Type | Receives |
|---|---|---|
| dried plum (100 g dried plum) | Experimental | Dietary Supplement: dried plumParticipants will receive 100 g dried plum daily plus 500 mg calcium and 300 IU vitamin D daily |
| Calcium and vitamin D | Placebo comparator | Dietary Supplement: Calcium and vitamin DParticipants will receive 500 mg calcium and 300 IU vitamin D daily |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy men (50-79 year-old)
Key exclusion criteria (6 listed)
- endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
- Men whose BMD t-score at any site falls below 2.5 SD of the mean will be excluded from the study and referred to their primary care physician
- subjects treated with calcitonin, bisphosphonates, raloxifene, sodium fluoride, anabolic agents, e.g. PTH and growth hormone, or steroids for less than 3 months prior to the start of the study will be excluded.
- body mass index (BMI) <18 and >30 will be excluded to avoid extremes in leanness/adiposity and to readily allow body composition assessment.
- If subjects smoke 20 cigarettes or more per day, they will be excluded.
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 |
|---|---|---|
| dried plumDried plum | Dietary supplement | dried plum (100 g dried plum) |
| Calcium and vitamin DCalcium and vitamin D supplement | Dietary supplement | Calcium and vitamin D |
Primary outcome
Bone biomarkers
Time frame: changes from baseline to 3 months
TRAP5b, BAP, CTX, P1NP
1 secondary outcome
Bone mineral density
Time frame: changes from baseline to 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 22 Jan 2021.
- Derived from this study: PubMed 34714130Hooshmand S, Gaffen D, Eisner A, Fajardo J, Payton M, Kern M. Effects of 12 Months Consumption of 100 g Dried Plum (Prunes) on Bone Biomarkers, Density, and Strength in Men. J Med Food. 2022 Jan;25(1):40-47. doi: 10.1089/jmf.2021.0080. Epub 2021 Oct 29.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Shirin Hooshmand, PhD, RD 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 dried plum and Calcium and vitamin D in people with Osteoporosis and Osteopenia, 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 1 inclusion and 6 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 22 Jan 2021. 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 biomarkers (time frame: changes from baseline to 3 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 NCT04720833, 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 22 Jan 2021.