Bone Diseases, MetabolicNCT02325895
Dried Plums for Bone Health in Older Postmenopausal Women
A study testing Dried Plum in people with Bone Diseases, Metabolic, run by San Diego State University.
Trial summary
The objective of the investigators current study was to examine whether 50 g dried plum would be as effective as 100 g dried plum in reversing bone loss in osteopenic older postmenopausal women. Read more about this study
- Who is it for?
- Ages 65 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Diseases, Metabolic
- What is being tested?
- Dried Plum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Apr 2014
- 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 65 to 79 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- BMD t-score of L1-L4 between -1 to -2.5 standard deviation of the mean
- Age 65 to 79
Who cannot join
- BMD t-score at any site fell below 2.5 standard deviation of the mean
- Subjects treated with calcitonin, bisphosphonates, raloxifene and/or anabolic agents such as parathyroid hormone and growth hormone, or steroids within three months before the start of the study
- 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 were not included in the study.
About this study
Official title: Effect of Dried Plum on Bone and Bone Biomarkers in Older Women
The objective of the investigators current study was to examine whether 50 g dried plum would be as effective as 100 g dried plum in reversing bone loss in osteopenic older postmenopausal women.
Read the detailed description
Forty-five randomly assigned into one of three treatment groups: 1) 50g dried plum; 2) 100g dried plum; and 3) control (0g dried plum). All groups received 500mg calcium and 400 IU vitamin D as a daily supplement. Blood samples were collected at baseline, 3 and 6 months to assess biomarkers of bone turnover. Physical activity recall and 3-day food records were obtained at baseline, 3 and 6 months to examine physical activity and dietary confounders as potential covariates
- Conditions
- Bone Diseases, Metabolic
- Being tested
- Dried Plum
- Keywords
- Osteoporosis, Dried plum, functional food
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried PlumOther
Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control (0 g Dried plum/day) | No intervention | Participants only received 400IU of vitamin D and 500mg of calcium daily for 6 months. |
| 50 g Dried plum/day | Experimental | Participants received 400IU of vitamin D and 500mg of calcium and 50g of dried plum daily for 6 months. Receives: Other: Dried Plum |
| 100 g Dried plum/day | Experimental | Participants received 400IU of vitamin D and 500mg of calcium and 100g of dried plum daily for 6 months. Receives: Other: Dried Plum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Measured: 6 months
Secondary outcomes (1)
Changes from baseline in bone specific alkaline phosphatase at 3 months and 6 months
Measured: baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startAug 2012
- Primary completionApr 2014
- Study completionApr 2014
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 Bone Diseases, 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- Florida State University
- Responsible party
- Principal investigator, Dr. Shirin Hooshmand, San Diego State University
- Investigators
- Shirin Hooshmand, PhD, Principal investigator, San Diego State Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325895
- Sponsor's protocol ID
- 57114A
- Status last verified
- Dec 2014
- First submitted
- 11 Dec 2014
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hooshmand S, Kern M, Metti D, Shamloufard P, Chai SC, Johnson SA, Payton ME, Arjmandi BH. The effect of two doses of dried plum on bone density and bone biomarkers in osteopenic postmenopausal women: a randomized, controlled trial. Osteoporos Int. 2016 Jul;27(7):2271-2279. doi: 10.1007/s00198-016-3524-8. Epub 2016 Feb 22.
PubMed 26902092
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dried Plum on Bone and Bone Biomarkers in Older Women
- ClinicalTrials.gov ID
- NCT02325895
- Acronym / sponsor ID
- 57114A
- Conditions
- Bone Diseases, Metabolic
- Keywords
- Osteoporosis, Dried plum, functional food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- Florida State University
- Study start
- Aug 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Dec 2014 (estimated)
- 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 the investigators current study was to examine whether 50 g dried plum would be as effective as 100 g dried plum in reversing bone loss in osteopenic older postmenopausal women.
Detailed description
Forty-five randomly assigned into one of three treatment groups: 1) 50g dried plum; 2) 100g dried plum; and 3) control (0g dried plum). All groups received 500mg calcium and 400 IU vitamin D as a daily supplement. Blood samples were collected at baseline, 3 and 6 months to assess biomarkers of bone turnover. Physical activity recall and 3-day food records were obtained at baseline, 3 and 6 months to examine physical activity and dietary confounders as potential covariates
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (0 g Dried plum/day) | No intervention | –Participants only received 400IU of vitamin D and 500mg of calcium daily for 6 months. |
| 50 g Dried plum/day | Experimental | Other: Dried PlumParticipants received 400IU of vitamin D and 500mg of calcium and 50g of dried plum daily for 6 months. |
| 100 g Dried plum/day | Experimental | Other: Dried PlumParticipants received 400IU of vitamin D and 500mg of calcium and 100g of dried plum daily for 6 months. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- BMD t-score of L1-L4 between -1 to -2.5 standard deviation of the mean
- Age 65 to 79
Key exclusion criteria (4 listed)
- BMD t-score at any site fell below 2.5 standard deviation of the mean
- Subjects treated with calcitonin, bisphosphonates, raloxifene and/or anabolic agents such as parathyroid hormone and growth hormone, or steroids within three months before the start of the study
- 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 were not included in the study.
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 PlumThree doses of dried plum (0 g, 50 g and 100g) were used as intervention. | Other | 100 g Dried plum/day, 50 g Dried plum/day |
Primary outcome
Bone Mineral Density
Time frame: 6 months
1 secondary outcome
Changes from baseline in bone specific alkaline phosphatase at 3 months and 6 months
Time frame: baseline, 3 months and 6 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 25 Dec 2014.
- Derived from this study: PubMed 26902092Hooshmand S, Kern M, Metti D, Shamloufard P, Chai SC, Johnson SA, Payton ME, Arjmandi BH. The effect of two doses of dried plum on bone density and bone biomarkers in osteopenic postmenopausal women: a randomized, controlled trial. Osteoporos Int. 2016 Jul;27(7):2271-2279. doi: 10.1007/s00198-016-3524-8. Epub 2016 Feb 22.
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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 principal investigator
San Diego State Univeristy
Questions about this trial
What is this clinical trial studying?
A study testing Dried Plum in people with Bone Diseases, Metabolic, run by San Diego State University.
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 2 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: finished, as of the sponsor's last update on 25 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Bone Mineral Density (time frame: 6 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 NCT02325895, 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 25 Dec 2014.