Postmenopausal OsteoporosisNCT02822378
Dried Plums and Bone Health in Postmenopausal Women
A study testing Dried Plum, Calcium supplement and Vitamin D supplement in people with Postmenopausal Osteoporosis, run by Penn State University at 1 site in United States.
Trial summary
Postmenopausal women often seek non-pharmacologic interventions for the protection of bone health. Previous research in humans and rodents has indicated that dietary dried plum consumption may be beneficial for bone health, especially in postmenopausal women. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Dried Plum, Calcium supplement and Vitamin D supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 31 Dec 2027
- 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 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- not severely obese (BMI < 40 kg/m2);
- healthy (determined by a screening questionnaire, complete metabolic panel);
- willing to include dried plums in their daily diet;
- not taking any natural dietary supplement containing phenolics, blueberries or apples for at least 2 months prior to study entry; can stop for 2 months to meet entry criteria
- non-smoking; ambulatory;
- low BMD as measured by dual energy X-ray absorptiometry (DXA). Eligible BMD values (T-scores) for DXA measures of the lumbar spine, total hip and/or femoral neck will correspond to T-scores between 0 and -3.0.
Who cannot join
- Women who regularly consume dried plums, dried apples, prune juice, or heavy consumers of blueberries (1 cup or more/day). Potential volunteers who will refrain from consumption of the afore mentioned foods for the duration of the study will become eligible after a 2 month washout period;
- vitamin D deficiency (<20 ng/mL);
- history of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 50 yr);
- untreated hyper- or hypothyroidism;
- current hyper- or hypoparathyroidism;
- significantly impaired renal function; high potassium
Show all 20Show fewer
- current hypo- or hypercalcemia;
- history of spinal stenosis;
- history of heart attack, stroke, thromboembolism, kidney disease, malabsorption syndrome, seizure disorders;
- positive for HIV, Hep-C or Hep-B surface antigen and malignancy.
- Use of the following agents affecting bone metabolism:
- intravenous bisphosphonates at any time;
- fluoride (for osteoporosis) within the past 24 months;
- denosumab at any time;
- bisphosphonates, parathyroid hormone or strontium within the past 12 months;
- calcitonin or selective estrogen receptor modulators within the past 12 months;
- systemic oral or transdermal estrogen within the past 3 months;
- systemic glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than 10 days); or
- tibolone within the past 3 months.
- Participants who will not consume study therapy or will not stop taking natural product supplements of their own selection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Health and Exercise Laboratories, The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Randomized Control Trial of Dietary Supplementation With Dried Plums on Bone Density, Geometry and Estimated Bone Strength in Postmenopausal Women
Postmenopausal women often seek non-pharmacologic interventions for the protection of bone health. Previous research in humans and rodents has indicated that dietary dried plum consumption may be beneficial for bone health, especially in postmenopausal women. However, it is unknown in what quantity dried plums need to be consumed to be of benefit and through what mechanisms dried plums act to impact bone health. Therefore, the purpose of this study is to evaluate the impact of 52 weeks of dried plums consumption in varying quantities on bone mineral density (BMD), bone geometry, and estimated bone strength in postmenopausal women. The investigators also seek to evaluate the mechanisms underlying the effects of dried plums as a dietary supplement by assessing polyphenols and the bioavailable conjugated metabolites in the urine of postmenopausal women taking different doses of dietary dried plums. The investigators aim to further investigate the mechanisms of dried plum action on bone by measuring markers of bone metabolism in response to dried plum consumption.
Read the detailed description
Given the current high incidence of osteoporosis, reducing the risk of osteoporosis development is essential. Recent estimates, based on the 2010 US Census, indicate that approximately 10.3 million people age 50 and older have osteoporosis. By 2030 the prevalence of osteoporosis for women 50 years and older is projected to reach 13.6 million. Postmenopausal osteoporosis is characterized not only by hypoestrogenism, but also by increased production of reactive oxygen species, oxidative stress, and inflammatory response. Current first line strategies are treatment of osteoporosis with pharmacologic approaches. Complementary recommendations include the maintenance of calcium (Ca2+) and vitamin D (VitD) intake to meet the current recommendations. Although the anti-resorptive therapies are effective they are also associated with an array of negative side effects, which reduce patient compliance to use of the therapy.
Non-pharmacologic options to reducing the risk of bone loss are becoming more attractive to many postmenopausal women. The phenolics and bioavailable conjugated metabolites found in dried plums are proposed to modulate the inflammatory signaling pathways and have the potential to influence bone formation and bone resorption, thus modulating the risk of bone loss. The investigators are conducting a 52 week dose ranging randomized controlled trial that builds upon previous rodent and human work and addresses the experimental design limitations of the previous work, to assess bone outcomes with clinical (BMD) and mechanistic (bone geometry, bone metabolism markers, and inflammation markers) techniques. Additionally, this study will include a detailed assessment of the phenolics in the dried plums to explore the relationship between these compounds and bone outcomes.
Participants will participate in a 1-2 week screening period followed by a 1-2 week baseline period. At the end of baseline randomization to 1 of 3 groups will occur (Ca2+ and VitD only; 50g Dried Plums/day and Ca2+ and VitD; 100g Dried Plums/day and Ca2+ and VitD). Dried plums and Calcium/Vitamin D supplements will be provided to participants for the duration of the intervention. At the beginning of the 52 week intervention participants will begin consumption of dried plums and will be given a run in period where the number of dried plums consumed per day increases slowly to minimize the side effects felt by the participants. The dried plums will be consumed as snacks in the morning, midday, and in the evening. Participants will visit the laboratory for testing every 4 weeks during the 52 week intervention, with more testing occurring during weeks 12, 24, 36, and 52 than the other testing periods.
At testing period visits participants will be asked to complete some or all of the following: body weight measurement; blood sampling; 24-hour urine collection; stool sample collection; DXA scan; peripheral quantitative computed tomography (pQCT) scan; completion of health, physical activity, and nutrition questionnaires; completion of supplement/symptom, diet, and physical activity logs.
A total of 300 participants will be enrolled and screed with an expected randomization of 79 participants per group. The investigators anticipate a 20% drop-out rate between baseline and week 52, thus will anticipate having a final sample size of 63 participants per group complete the study. This sample size provides over 80% power to detect differences with the primary BMD, bone geometry, and bone strength variables.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Dried Plum, Calcium supplement, Vitamin D supplement
- Keywords
- Postmenopausal Osteoporosis, Human, Female, Non-pharmacologic therapy
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried PlumDietary supplement
Also called Prunes
Participants randomized to the 50g dried plum group will consume 6 dried plums per day for the duration of the 52 week intervention. Participants randomized to the 100g dried plum group will consume 12 dried plums per day for the duration of the 52 week intervention.
Calcium supplementDietary supplement
All participants will consume calcium supplements for the duration of baseline and intervention.
Vitamin D supplementDietary supplement
All participants will consume vitamin D supplements for the duration of baseline and intervention.
| Study group | Role | What they receive |
|---|---|---|
| Ca2+/VitD Control | Experimental | Participants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Participants will be asked to refrain from consumption of dried plums for the duration of the intervention (52 weeks). Receives: Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D supplement |
| 50g Dried Plums | Experimental | Participants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Additionally, participants will be provided with dried plums and asked to consume 6 (50g) dried plums per day for the duration of the intervention (52 weeks). Receives: Dietary Supplement: Dried Plum; Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D supplement |
| 100g Dried Plums | Experimental | Participants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Additionally, participants will be provided with dried plums and asked to consume 12 (100g) dried plums per day for the duration of the intervention (52 weeks). Receives: Dietary Supplement: Dried Plum; Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in areal bone mineral density (via DXA) of the lumbar spine, total hip, and femoral neck
Percent change in areal BMD measured during screening, and weeks 24 and 52 of the 52 week dietary intervention at the lumbar spine, total hip, and femoral neck.
Measured: at screening, week 24, and week 52
Secondary outcomes (6)
Percent change from baseline in DXA hip structural analysis
Percent change in hip structural analysis (HSA) measured during screening, and weeks 24 and 52 of the 52 week dietary intervention at the total hip.
Measured: at screening, week 24, and week 52
Percent change from baseline in DXA spine trabecular bone score
Percent change in trabecular bone score (TBS) measured during screening, and weeks 24 and 52 of the 52 week dietary intervention at the lumbar spine.
Measured: at screening, week 24, and week 52
Percent change from baseline in pQCT volumetric BMD of the tibia and radius
Percent change in volumetric BMD, cortical and trabecular compartments, measured during baseline, and weeks 24 and 52 of the 52 week dietary intervention at the tibia and radius. The combination of measurements will provide an overall picture of the 3-dimensional structure of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention.
Measured: at baseline, week 24, and week 52
Percent change from baseline in pQCT geometry measurements of the tibia and radius
Percent change in bone geometry estimates measured during baseline, and weeks 24 and 52 of the 52 week dietary intervention at the tibia and radius. The combination of measurements will provide an overall picture of the 3-dimensional structure of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention.
Measured: at baseline, week 24, and week 52
Percent change from baseline in pQCT strength measurements of the tibia and radius
Percent change in bone strength estimates measured during baseline, and weeks 24 and 52 of the 52 week dietary intervention at the tibia and radius. The combination of measurements will provide an overall picture of the 3-dimensional structure of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention.
Measured: at baseline, week 24, and week 52
Change from baseline in bone turnover markers
Change in serially-sampled fasting serum concentrations of bone formation (N-terminal type 1 procollagen; P1NP) and bone resorption (crosslaps; CTx) before, during and after the dietary intervention. The combined measures will provide information regarding changes in the rate of bone resorption and bone formation.
Measured: at baseline, week 12, week 24, week 36, and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start1 Jun 2016
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Penn 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
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- California Dried Plum Board
- Responsible party
- Principal investigator, Mary Jane DeSouza, Penn State University
- Investigators
- Mary Jane De Souza, PhD, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822378
- Sponsor's protocol ID
- Study00004252
- Status last verified
- Jul 2026
- First submitted
- 27 May 2016
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Damani JJ, Rogers CJ, Lee H, Strock NC, Koltun KJ, Williams NI, Weaver C, Ferruzzi MG, Nakatsu CH, De Souza MJ. Effects of Prune (Dried Plum) Supplementation on Cardiometabolic Health in Postmenopausal Women: An Ancillary Analysis of a 12-Month Randomized Controlled Trial, The Prune Study. J Nutr. 2024 May;154(5):1604-1618. doi: 10.1016/j.tjnut.2024.03.012. Epub 2024 Mar 13.
PubMed 38490532Damani JJ, Oh ES, De Souza MJ, Strock NC, Williams NI, Nakatsu CH, Lee H, Weaver C, Rogers CJ. Prune Consumption Attenuates Proinflammatory Cytokine Secretion and Alters Monocyte Activation in Postmenopausal Women: Secondary Outcome Analysis of a 12-Mo Randomized Controlled Trial: The Prune Study. J Nutr. 2024 May;154(5):1699-1710. doi: 10.1016/j.tjnut.2023.11.014. Epub 2023 Nov 19.
PubMed 37984741De Souza MJ, Strock NCA, Williams NI, Lee H, Koltun KJ, Rogers C, Ferruzzi MG, Nakatsu CH, Weaver C. Prunes preserve hip bone mineral density in a 12-month randomized controlled trial in postmenopausal women: the Prune Study. Am J Clin Nutr. 2022 Oct 6;116(4):897-910. doi: 10.1093/ajcn/nqac189.
PubMed 35798020
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Dietary Supplementation With Dried Plums on Bone Density, Geometry and Estimated Bone Strength in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02822378
- Acronym / sponsor ID
- Study00004252
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Postmenopausal Osteoporosis, Human, Female, Non-pharmacologic therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- California Dried Plum Board
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Jul 2016 (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.
Postmenopausal women often seek non-pharmacologic interventions for the protection of bone health. Previous research in humans and rodents has indicated that dietary dried plum consumption may be beneficial for bone health, especially in postmenopausal women. However, it is unknown in what quantity dried plums need to be consumed to be of benefit and through what mechanisms dried plums act to impact bone health. Therefore, the purpose of this study is to evaluate the impact of 52 weeks of dried plums consumption in varying quantities on bone mineral density (BMD), bone geometry, and estimated bone strength in postmenopausal women. The investigators also seek to evaluate the mechanisms underlying the effects of dried plums as a dietary supplement by assessing polyphenols and the bioavailable conjugated metabolites in the urine of postmenopausal women taking different doses of dietary dried plums. The investigators aim to further investigate the mechanisms of dried plum action on bone by measuring markers of bone metabolism in response to dried plum consumption.
Detailed description
Given the current high incidence of osteoporosis, reducing the risk of osteoporosis development is essential. Recent estimates, based on the 2010 US Census, indicate that approximately 10.3 million people age 50 and older have osteoporosis. By 2030 the prevalence of osteoporosis for women 50 years and older is projected to reach 13.6 million. Postmenopausal osteoporosis is characterized not only by hypoestrogenism, but also by increased production of reactive oxygen species, oxidative stress, and inflammatory response. Current first line strategies are treatment of osteoporosis with pharmacologic approaches. Complementary recommendations include the maintenance of calcium (Ca2+) and vitamin D (VitD) intake to meet the current recommendations. Although the anti-resorptive therapies are effective they are also associated with an array of negative side effects, which reduce patient compliance to use of the therapy.
Non-pharmacologic options to reducing the risk of bone loss are becoming more attractive to many postmenopausal women. The phenolics and bioavailable conjugated metabolites found in dried plums are proposed to modulate the inflammatory signaling pathways and have the potential to influence bone formation and bone resorption, thus modulating the risk of bone loss. The investigators are conducting a 52 week dose ranging randomized controlled trial that builds upon previous rodent and human work and addresses the experimental design limitations of the previous work, to assess bone outcomes with clinical (BMD) and mechanistic (bone geometry, bone metabolism markers, and inflammation markers) techniques. Additionally, this study will include a detailed assessment of the phenolics in the dried plums to explore the relationship between these compounds and bone outcomes.
Participants will participate in a 1-2 week screening period followed by a 1-2 week baseline period. At the end of baseline randomization to 1 of 3 groups will occur (Ca2+ and VitD only; 50g Dried Plums/day and Ca2+ and VitD; 100g Dried Plums/day and Ca2+ and VitD). Dried plums and Calcium/Vitamin D supplements will be provided to participants for the duration of the intervention. At the beginning of the 52 week intervention participants will begin consumption of dried plums and will be given a run in period where the number of dried plums consumed per day increases slowly to minimize the side effects felt by the participants. The dried plums will be consumed as snacks in the morning, midday, and in the evening. Participants will visit the laboratory for testing every 4 weeks during the 52 week intervention, with more testing occurring during weeks 12, 24, 36, and 52 than the other testing periods.
At testing period visits participants will be asked to complete some or all of the following: body weight measurement; blood sampling; 24-hour urine collection; stool sample collection; DXA scan; peripheral quantitative computed tomography (pQCT) scan; completion of health, physical activity, and nutrition questionnaires; completion of supplement/symptom, diet, and physical activity logs.
A total of 300 participants will be enrolled and screed with an expected randomization of 79 participants per group. The investigators anticipate a 20% drop-out rate between baseline and week 52, thus will anticipate having a final sample size of 63 participants per group complete the study. This sample size provides over 80% power to detect differences with the primary BMD, bone geometry, and bone strength variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ca2+/VitD Control | Experimental | Dietary Supplement: Calcium supplement, Dietary Supplement: Vitamin D supplementParticipants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Participants will be asked to refrain from consumption of dried plums for the duration of the intervention (52 weeks). |
| 50g Dried Plums | Experimental | Dietary Supplement: Dried Plum, Dietary Supplement: Calcium supplement, Dietary Supplement: Vitamin D supplementParticipants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Additionally, participants will be provided with dried plums and asked to consume 6 (50g) dried plums per day for the duration of the intervention (52 weeks). |
| 100g Dried Plums | Experimental | Dietary Supplement: Dried Plum, Dietary Supplement: Calcium supplement, Dietary Supplement: Vitamin D supplementParticipants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Additionally, participants will be provided with dried plums and asked to consume 12 (100g) dried plums per day for the duration of the intervention (52 weeks). |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Postmenopausal women
- not severely obese (BMI < 40 kg/m2);
- healthy (determined by a screening questionnaire, complete metabolic panel);
- willing to include dried plums in their daily diet;
- not taking any natural dietary supplement containing phenolics, blueberries or apples for at least 2 months prior to study entry; can stop for 2 months to meet entry criteria
Key exclusion criteria (20 listed)
- Women who regularly consume dried plums, dried apples, prune juice, or heavy consumers of blueberries (1 cup or more/day). Potential volunteers who will refrain from consumption of the afore mentioned foods for the duration of the study will become eligible after a 2 month washout period;
- vitamin D deficiency (<20 ng/mL);
- history of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 50 yr);
- untreated hyper- or hypothyroidism;
- current hyper- or hypoparathyroidism;
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 PlumAlso: PrunesParticipants randomized to the 50g dried plum group will consume 6 dried plums per day for the duration of the 52 week intervention. Participants randomized to the 100g dried plum group will consume 12 dried plums per day for the duration of the 52 week intervention. | Dietary supplement | 100g Dried Plums, 50g Dried Plums |
| Calcium supplementAll participants will consume calcium supplements for the duration of baseline and intervention. | Dietary supplement | 100g Dried Plums, 50g Dried Plums, Ca2+/VitD Control |
| Vitamin D supplementAll participants will consume vitamin D supplements for the duration of baseline and intervention. | Dietary supplement | 100g Dried Plums, 50g Dried Plums, Ca2+/VitD Control |
Primary outcome
Percent change from baseline in areal bone mineral density (via DXA) of the lumbar spine, total hip, and femoral neck
Time frame: at screening, week 24, and week 52
Percent change in areal BMD measured during screening, and weeks 24 and 52 of the 52 week dietary intervention at the lumbar spine, total hip, and femoral neck.
6 secondary outcomes
Percent change from baseline in DXA hip structural analysis
Time frame: at screening, week 24, and week 52
Percent change from baseline in DXA spine trabecular bone score
Time frame: at screening, week 24, and week 52
Percent change from baseline in pQCT volumetric BMD of the tibia and radius
Time frame: at baseline, week 24, and week 52
Percent change from baseline in pQCT geometry measurements of the tibia and radius
Time frame: at baseline, week 24, and week 52
Percent change from baseline in pQCT strength measurements of the tibia and radius
Time frame: at baseline, week 24, and week 52
Change from baseline in bone turnover markers
Time frame: at baseline, week 12, week 24, week 36, and week 52
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 6 Jul 2026.
- Derived from this study: PubMed 38490532Damani JJ, Rogers CJ, Lee H, Strock NC, Koltun KJ, Williams NI, Weaver C, Ferruzzi MG, Nakatsu CH, De Souza MJ. Effects of Prune (Dried Plum) Supplementation on Cardiometabolic Health in Postmenopausal Women: An Ancillary Analysis of a 12-Month Randomized Controlled Trial, The Prune Study. J Nutr. 2024 May;154(5):1604-1618. doi: 10.1016/j.tjnut.2024.03.012. Epub 2024 Mar 13.
- Derived from this study: PubMed 37984741Damani JJ, Oh ES, De Souza MJ, Strock NC, Williams NI, Nakatsu CH, Lee H, Weaver C, Rogers CJ. Prune Consumption Attenuates Proinflammatory Cytokine Secretion and Alters Monocyte Activation in Postmenopausal Women: Secondary Outcome Analysis of a 12-Mo Randomized Controlled Trial: The Prune Study. J Nutr. 2024 May;154(5):1699-1710. doi: 10.1016/j.tjnut.2023.11.014. Epub 2023 Nov 19.
- Derived from this study: PubMed 35798020De Souza MJ, Strock NCA, Williams NI, Lee H, Koltun KJ, Rogers C, Ferruzzi MG, Nakatsu CH, Weaver C. Prunes preserve hip bone mineral density in a 12-month randomized controlled trial in postmenopausal women: the Prune Study. Am J Clin Nutr. 2022 Oct 6;116(4):897-910. doi: 10.1093/ajcn/nqac189.
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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.
Mary Jane De Souza, PhD principal investigator
The Pennsylvania 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, Calcium supplement and Vitamin D supplement in people with Postmenopausal Osteoporosis, run by Penn 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 7 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 6 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?
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?
Percent change from baseline in areal bone mineral density (via DXA) of the lumbar spine, total hip, and femoral neck (time frame: at screening, week 24, and week 52). 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 NCT02822378, which also lists 3 linked publications.
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 6 Jul 2026.