NCT07120997 · Penn State University
Prunes Preventing Bone Loss in Perimenopause
(Prune-UP)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- University Park, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 4, 2026 · Source of record for eligibility and locations