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Recruiting NCT07120997

Prunes Preventing Bone Loss in Perimenopause

Trial Parameters

Condition Perimenopausal Bone Loss
Sponsor Penn State University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 124
Sex FEMALE
Min Age 44 Years
Max Age 55 Years
Start Date 2025-12-11
Completion 2029-09
Interventions
PrunesCalcium supplementVitamin D Supplement

Brief Summary

Dietary interventions of prune consumption during the transmenopausal period are innovative methods to prevent bone loss. Modern medicine does not intervene to prevent or attenuate this highly vulnerable period of bone loss which, if successfully attenuated, can potentially prevent/delay osteoporosis in women. The transmenopausal period represents an opportunistic window for the study because bone loss is at its greatest at this time, with females losing as much as 6-7% of bone. If this project is successful at attenuating bone loss, it can immediately be disseminated to the public to promote prune consumption to slow down and attenuate perimenopausal bone loss. As such, this project could improve the long-term bone health of females and avoid or delay osteoporosis and improve quality of life. The long-term goal of this study is to test the novel hypothesis that prune consumption for 18 months during the 3-year transmenopausal period prevents the dramatic rate of bone loss in perimenopausal females during a window of heightened physiological vulnerability. At Penn State University, the study will compare the effects of 18 months of daily dietary consumption of 50 g of prunes (5-6) versus a no-prune control group on bone outcomes (bone mineral density, bone geometry), mechanistic factors (bone and inflammatory markers, inflammatory response of ex vivo cultured peripheral blood mononuclear cells, monocytes), and gut microbiome.

Eligibility 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 * Signifi

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