Dried Plums and Bone Health in Postmenopausal Women

Running, not enrolling · Not applicable

Conditions studied: Postmenopausal Osteoporosis

In brief

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.

Key facts

Study ID

NCT02822378

Run by

Penn State University

People needed

322

Starts

2016-06-01

Expected to finish

2027-12-31

Last updated by the study team

2026-07-06

Who can join

Age: 55 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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.

Where it is running

• Women's Health and Exercise Laboratories, The Pennsylvania State University — University Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

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