Daily prunes to slow bone loss during perimenopause

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants in the transmenopausal window will add prunes to their daily diet for up to 18 months while receiving standard calcium and vitamin D supplementation and clinical monitoring. Bone density at the spine and hip, blood tests, and safety measures will be collected over time to track changes in bone loss. The protocol excludes people with surgical menopause, prior fragility fractures, certain endocrine disorders, or heavy regular consumption of prunes/berries. If the intervention slows bone loss, it could be adopted widely as a low-cost dietary prevention strategy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 44 to 55 years
* Not severely obese (BMI \<35 kg/m\^2)
* Healthy (determined by a screening questionnaire, physical and medical history by a certified nurse practitioner, complete metabolic panel, and complete blood count)
* Willing to include prunes in their daily diet
* Not taking any natural dietary supplement containing phenolics, i.e.,\< 1 cup/day of blueberries or apples for at least 2 months prior to study entry
* Non-smoking
* Ambulatory
* No menses for ≥60 days but not more than 18 months post final menstrual period
* Only participants who have a determinable natural (not surgical) final menstrual period date are eligible

Exclusion Criteria:

* Subjects who regularly consume prunes, dried apples, prune juice, or heavy consumers of blueberries (1 cup or more/day)
* History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 45 yr)
* Untreated hyper- or hypothyroidism
* Current hyper- or hypoparathyroidism
* Significantly impaired renal function
* Current hypo- or hypercalcemia
* History of spinal stenosis
* History of heart attack, stroke, thromboembolism, kidney disease, malabsorption syndrome, or 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; 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
* Hormonal contraception within the past three months
* Subjects who will not consume study provided dietary items or who will not stop taking their own natural product supplements

Where it's running

• Women's Health and Exercise Laboratory, The Pennsylvania State University
  University Park, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Mary Jane De Souza, PhD
• Email: mjd34@psu.edu
• Phone: 814-863-0045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.