Actively Recruiting
Prunes Preventing Bone Loss in Perimenopause
Led by Penn State University · Updated on 2026-02-04
124
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
Sponsors
P
Penn State University
Lead Sponsor
U
University of Georgia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prunes Preventing Bone Loss in Perimenopause
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 44 to 55 years
- Not severely obese (BMI less than 35 kg/m2)
- Healthy based on screening questionnaire, medical history, and lab tests
- Willing to eat prunes daily
- Not taking natural dietary supplements with phenolics (less than 1 cup/day of blueberries or apples) for at least 2 months before joining
- Non-smoker
- Able to walk independently
- No menstrual periods for at least 60 days but less than 18 months after final natural menstrual period
- Must have a known natural final menstrual period date
You will not qualify if you...
- Regular consumption of prunes, dried apples, prune juice, or more than 1 cup of blueberries daily
- History of vertebral or fragility fractures after age 45
- Untreated thyroid disorders
- Current parathyroid disorders
- Significant kidney problems
- Abnormal calcium levels currently
- History of spinal stenosis
- History of heart attack, stroke, blood clots, kidney disease, malabsorption, or seizures
- Positive for HIV, Hepatitis B or C, or cancer
- Use of certain bone-affecting medications recently or ever (intravenous bisphosphonates, fluoride, denosumab, oral bisphosphonates, parathyroid hormone, strontium, calcitonin, SERMs, systemic estrogen, systemic glucocorticosteroids, tibolone)
- Use of hormonal contraception in the past 3 months
- Unwillingness to consume study dietary items or to stop own natural supplements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Women's Health and Exercise Laboratory, The Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Actively Recruiting
Research Team
M
Mary Jane De Souza, PhD
CONTACT
N
Nancy I. Williams, ScD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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