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Clinical Trial NCT07120997 (Prune-UP) for Perimenopausal Bone Loss is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Penn State UniversityPrunes Preventing Bone Loss in Perimenopause (Prune-UP) 124 Microbiome Dietary Novel Treatment
Clinical Trial NCT07120997 (Prune-UP) is an interventional study for Perimenopausal Bone Loss that is recruiting. It started on December 11, 2025 with plans to enroll 124 participants. Led by Penn State University, it is expected to complete by December 1, 2029. The latest data from ClinicalTrials.gov was last updated on February 4, 2026.
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 grea...Show More
Detailed Description
Females spend at least one-third of their lifespan after menopause, therefore strategies that improve the long-term health of women and engage a prevention strategy to improve health are warranted and represent opportunities for high impact and high return on investment. After menopause, one in two females will suffer a fragility fracture in their lifetime, and the mortality rate after a hip fracture is as high as 25...Show More
Official Title
A Prevention Strategy for the Indication of Prune Consumption in Perimenopausal Females: Can Prunes Attenuate Bone Loss?
Conditions
Perimenopausal Bone LossOther Study IDs
- Prune-UP
- STUDY00027323
- 14223973 (Other Grant/Funding Number) (United States Department of Agriculture)
NCT ID Number
Start Date (Actual)
2025-12-11
Last Update Posted
2026-02-04
Completion Date (Estimated)
2029-12
Enrollment (Estimated)
124
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Female
Transmenopause
Perimenopause
Perimenopausal Bone Loss
Menopause
Human
Osteoporosis
Non-pharmacologic therapy
Prune intake
Dried Plum
Transmenopause
Perimenopause
Perimenopausal Bone Loss
Menopause
Human
Osteoporosis
Non-pharmacologic therapy
Prune intake
Dried Plum
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCalcium and Vitamin D - Control group Participants will take calcium and vitamin D supplements daily for a baseline period and for the duration of the intervention. Participants will be asked to refrain from consumption of prunes and fruits that have high phenolic content for the duration of the intervention (18 months). | Calcium supplement All participants will consume calcium supplements daily for a baseline period and for the duration of the 18-month intervention. Vitamin D Supplement All participants will consume Vitamin D supplements daily for a baseline period and for the duration of the 18-month intervention. |
Experimental50g Prunes, Calcium, and Vitamin D - Intervention Group Participants will take calcium and vitamin D supplements daily for a baseline period and for the duration of the intervention. Additionally, participants will be provided with prunes and asked to consume 6 (50g) prunes per day for the duration of the intervention (18 months). | Prunes Participants randomized to the 50g prune group will consume 6 prunes per day for the duration of the 18-month intervention. Calcium supplement All participants will consume calcium supplements daily for a baseline period and for the duration of the 18-month intervention. Vitamin D Supplement All participants will consume Vitamin D supplements daily for a baseline period and for the duration of the 18-month intervention. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Percent change from baseline in areal bone mineral density (via DXA) of the lumbar spine, total hip, and femoral neck | Percent change in areal bone mineral density measured at baseline, month 9, and month 18 of the 18-week dietary intervention at the lumbar spine, total hip, and femoral neck. | Baseline, month 9, month 18 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Changes from baseline in Spine Trabecular Bone Score (TBS) (via DXA) | Changes in Spine Trabecular Bone Score (TBS) assessed at baseline, month 9, and month 18 of the 18-month dietary intervention from lumbar spine DXA scans. The measurements will provide additional information about the effects of the intervention on trabecular bone. | Baseline, month 9, and month 18 |
Percent change from baseline in volumetric BMD of the tibia and radius (via pQCT) | Percent change in volumetric BMD, cortical and trabecular compartments, measured during baseline, month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The combination of measurements will provide an overall picture of the 3-dimensional structure of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention. | Baseline, month 9, and month 18 |
Percent change from baseline in bone geometry measurements of the tibia and radius (via pQCT) | Percent change in bone geometry estimates (total bone area, cortical and trabecular area, cortical thickness) measured during baseline, and month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The combination of measurements will provide an overall picture of the 3-dimensional structure of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention. | Baseline, month 9, and month 18 |
Percent change from baseline in bone strength index of the tibia and radius (via pQCT) | Percent change in bone strength index (BSI) measured during baseline, and month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The measurement will provide an overall picture of bone strength and of the 3-dimensional structure of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention. | Baseline, month 9, and month 18 |
Percent change from baseline in stress strain index of the tibia and radius (via pQCT) | Percent change in stress strain index (SSI), a bone strength measurement, measured during baseline, month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The measurements will provide an overall estimate of bone strength of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention. | Baseline, Month 9, Month 18 |
Percent change from baseline in polar moment of inertia measurements of the tibia and radius (via pQCT) | Percent change in polar moment of inertia (section modulus) measured during baseline, and month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The measurement will provide an overall picture of the 3-dimensional structure and bone strength of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention. | Baseline, Month 9, Month 18 |
Change from baseline in C-terminal telopeptide of type I collagen (CTx) | Change in serially-sampled fasting serum concentrations of C-terminal telopeptide of type I collagen (CTx), a marker of bone resorption, at baseline, month 9, and month 18 of the 18-month dietary intervention. Changes in bone resorption markers will assist in understanding the underlying mechanisms behind changes in the rates of bone resorption. | Baseline, month 9, and month 18 |
Change from baseline in Tartrate-resistant acid phosphatase (Trap 5b) | Change in serially-sampled fasting serum concentrations of Tartrate-resistant acid phosphatase (Trap 5b), a marker of bone resorption, at baseline, month 9, and month 18 of the 18-month dietary intervention. Changes in bone resorption markers will assist in understanding the underlying mechanisms behind changes in the rates of bone resorption. | Baseline, month 9, and month 18 |
Change from baseline in expression of inflammatory markers | Change in lipopolysaccharide(LPS)-stimulated peripheral blood mononuclear cell (PBMC) gene expression of inflammatory markers (interleukin-1β, interleukin-6, and tumor necrosis factor-α) at baseline, month 9, and month 18 of the dietary intervention. Additionally, the relationship between the changes in gene expression of inflammation markers and bone outcomes will be explored. The combined changes of the gene expression of inflammatory markers will provide a comprehensive picture of the inflammatory environment of the participants before, during and following the dietary intervention. This comprehensive picture will assist in understanding the mechanisms by which the inflammatory environment contributes to bone loss in transmenopause and how the dietary intervention impacts those factors. | Baseline, month 9, and month 18 |
Change from baseline in gut permeability | Change in serially-sampled fasting serum concentrations of zonulin, a gut permeability marker, at baseline, month 9, and month 18 of the 18-month dietary intervention. Changes in zonulin will assist in understanding the underlying mechanisms of changes in the gut and bone metabolism. | Baseline, month 9, and month 18 |
Change from baseline in gut microbiome | Serially-sampled stool samples for assessment of changes in the Beta diversity of gut microbiome at baseline, month 9, and month 18 of the 18-month dietary intervention. Additionally, the relationship between the changes in the gut microbiome and bone outcomes will be explored. | Baseline, month 9, and month 18 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
44 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
- 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
- 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
Penn State University91 active studies to exploreStudy Responsible Party
Mary Jane DeSouza, Principal Investigator, Distinguished Professor of Kinesiology and Physiology, Penn State University
Study Central Contact
Contact: Mary Jane De Souza, PhD, 814-863-0045, [email protected]
Contact: Nancy I. Williams, ScD, 814-865-1346, [email protected]
1 Study Locations in 1 Countries
Pennsylvania
Women's Health and Exercise Laboratory, The Pennsylvania State University, University Park, Pennsylvania, 16802, United States
Mary Jane De Souza, PhD, Contact, 814-863-0045, [email protected]
Nancy I. Williams, ScD, Contact, 814-865-1346, [email protected]
Mary Jane De Souza, PhD, Principal Investigator
Nancy I. Williams, ScD, Sub-Investigator
Recruiting