Prunes Preventing Bone Loss in Perimenopause

What this trial studies

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.

Conditions in scope

• Perimenopausal Bone Loss

Interventions

• Prunes (Dietary Supplement) — Participants randomized to the 50g prune group will consume 6 prunes per day for the duration of the 18-month intervention.
• Calcium supplement (Dietary Supplement) — All participants will consume calcium supplements daily for a baseline period and for the duration of the 18-month intervention.
• Vitamin D Supplement (Dietary Supplement) — All participants will consume Vitamin D supplements daily for a baseline period and for the duration of the 18-month intervention.

Who can join

Women only · Ages 44 Years to 55 Years · Accepts healthy volunteers.

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

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-12-11
• Primary completion: 2029-09
• Last update posted: 2026-02-04
• First posted: 2025-08-13

Sponsor & contact

Lead sponsor: Penn State University (Other)

Collaborators: University of Georgia, California Dried Plum Board, United States Department of Agriculture (USDA)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Percent change from baseline in areal bone mineral density (via DXA) of the lumbar spine, total hip, and femoral neck (Baseline, month 9, month 18)
  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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.