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Prunes for Preventing Bone Loss in Perimenopause

This study is looking at whether eating prunes can help prevent bone loss in women who are going through perimenopause (the time leading up to menopause). Participants will be randomly assigned to either eat 6 prunes daily or not, for 18 months. All participants will also take daily calcium and Vitamin D supplements. Researchers will measure changes in bone density in your spine and hip to see if prunes help. This study is for women aged 44 to 55 who are generally healthy and willing to include prunes in their diet. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 124 women, where participants will be randomly assigned to different groups.
What's involved
You would consume 6 prunes daily for 18 months, along with daily calcium and Vitamin D supplements. Your bone density will be measured at the start, at 9 months, and at 18 months.
Compensation
Not stated in the trial record.
Follow-up
Bone density will be measured at 9 and 18 months, indicating follow-up throughout the 18-month intervention period.

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NCT07120997

Prunes Preventing Bone Loss in Perimenopause

Recruiting
NAAges 44–55InterventionalPrevention
Penn State University
~124 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:PrunesCalcium supplementVitamin D Supplement

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent change from baseline in areal bone mineral density (via DXA) of the lumbar spine, total hip, and femoral neck
Measured over Baseline, month 9, month 18

Conditions

Perimenopausal Bone Loss

Explore related trials

OsteoporosisPerimenopausal

Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

Mary Jane De Souza, PhD
[email protected]
814-863-0045
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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