Active — Not RecruitingNot Applicable

Dried Plums and Bone Health in Postmenopausal Women

United States322 participantsStarted 2016-06-01

Plain-language 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. 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.

Who can participate

Age range

55 Years – 75 Years

Sex

FEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 a…

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent change from baseline in areal bone mineral density (via DXA) of the lumbar spine, total hip, and femoral neck

Timeframe: at screening, week 24, and week 52

Trial details

NCT IDNCT02822378

SponsorPenn State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Postmenopausal Osteoporosis trials