Actively Recruiting

Phase Not Applicable
Age: 44Years - 55Years
FEMALE
Healthy Volunteers
NCT07120997

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

Age: 44Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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