Daily prunes to slow bone loss during perimenopause
A Prevention Strategy for the Indication of Prune Consumption in Perimenopausal Females: Can Prunes Attenuate Bone Loss?
This trial will test whether eating prunes daily for 18 months can slow bone loss in people going through perimenopause.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 44 Years to 55 Years |
| Sex | Female |
| Sponsor | Penn State University Academic / other |
| Drugs / interventions | denosumab, prednisone |
| Locations | 1 site (University Park, Pennsylvania) |
| Trial ID | NCT07120997 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy, non-smoking people aged 44–55 who are in the transmenopausal window (no menses for ≥60 days but ≤18 months), have BMI <35, a natural final menstrual period date, and are willing to eat prunes daily.
Not a fit: People with surgical menopause, prior fragility fractures, untreated thyroid or parathyroid disease, heavy regular prune or berry consumption, smokers, or BMI ≥35 may not benefit or are excluded.
Why it matters
Potential benefit: If successful, eating prunes during the transmenopausal window could slow bone loss and lower the future risk of osteoporosis and fractures.
How similar studies have performed: Previous small trials of dried plums have shown promising bone-protective effects in postmenopausal women, but larger confirmatory trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
University Park, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.