Recruiting

Prune Consumption

Sponsor:

Penn State University

Code:

NCT07120997

Conditions

Perimenopausal Bone Loss

Eligibility Criteria

Sex: Female

Age: 44 - 55

Healthy Volunteers: Accepted

Interventions

Prunes

Calcium supplement

Vitamin D Supplement

Study Details

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 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

Perimenopausal Bone Loss

Study ID

NCT07120997

Start date

Dec 11, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 44 - 55

Healthy Volunteers: Accepted

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
  • 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

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Calcium 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).

experimental: 50g 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).

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Mary Jane De Souza, PhD

814-863-0045mjd34@psu.edu

Nancy I. Williams, ScD

814-865-1346niw1@psu.edu

Locations

Women's Health and Exercise Laboratory, The Pennsylvania State University

Recruiting

University Park, Pennsylvania, United States, 16802

Contacts

Mary Jane De Souza, PhD

814-863-0045mjd34@psu.edu

Nancy I. Williams, ScD

814-865-1346niw1@psu.edu

Principal Investigator:

Mary Jane De Souza, PhD

More Information

Sponsor

Penn State University

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • Female
  • Transmenopause
  • Perimenopause
  • Perimenopausal Bone Loss
  • Menopause
  • Human
  • Osteoporosis
  • Non-pharmacologic therapy
  • Prune intake
  • Dried Plum

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2026-02-04.