NCT02822378Active, not recruiting
Dried Plums and Bone Health in Postmenopausal Women
Randomized Control Trial of Dietary Supplementation With Dried Plums on Bone Density, Geometry and Estimated Bone Strength in Postmenopausal Women
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 322 (actual)
- First submitted
- 27 May 2016
- Start date
- 1 Jun 2016
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Penn State University
- Diseases
- Osteoporosis
- NCT number
- NCT02822378
What you commit to
- Study type: Interventional
- Participants enrolled: 322
- From 1 Jun 2016 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Participants who will not consume study therapy or will not stop taking natural product supplements of their own selection.
Other illness
- 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.
Lab values
- significantly impaired renal function; high potassium
Age
- history of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 50 yr);
Other
- vitamin D deficiency (\<20 ng/mL);
- untreated hyper- or hypothyroidism;
- current hyper- or hypoparathyroidism;
- current hypo- or hypercalcemia;
- 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.
Who the study is looking for
- 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.
Age in the registry: 55 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Women's Health and Exercise Laboratories, The Pennsylvania State University Coordinator of this site? Confirm its status | University Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.