Prunes Preventing Bone Loss in Perimenopause

NCT07120997 | Recruiting

• 2 other identifiers: STUDY0002732314223973
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Changes from baseline in Spine Trabecular Bone Score (TBS) (via DXA)

  Baseline, month 9, and month 18

• Percent change from baseline in volumetric BMD of the tibia and radius (via pQCT)

  Baseline, month 9, and month 18

• Percent change from baseline in bone geometry measurements of the tibia and radius (via pQCT)

  Baseline, month 9, and month 18

• Percent change from baseline in bone strength index of the tibia and radius (via pQCT)

  Baseline, month 9, and month 18

• Percent change from baseline in stress strain index of the tibia and radius (via pQCT)

  Baseline, Month 9, Month 18

Study Arms (2)

Calcium and Vitamin D - Control group

EXPERIMENTAL

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).

Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D Supplement

50g Prunes, Calcium, and Vitamin D - Intervention Group

EXPERIMENTAL

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).

Dietary Supplement: Prunes; Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D Supplement

Interventions

Calcium supplement DIETARY_SUPPLEMENT

All participants will consume calcium supplements daily for a baseline period and for the duration of the 18-month intervention.

50g Prunes, Calcium, and Vitamin D - Intervention Group; Calcium and Vitamin D - Control group

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.

50g Prunes, Calcium, and Vitamin D - Intervention Group; Calcium and Vitamin D - Control group

Prunes DIETARY_SUPPLEMENT

Participants randomized to the 50g prune group will consume 6 prunes per day for the duration of the 18-month intervention.

50g Prunes, Calcium, and Vitamin D - Intervention Group

Eligibility Criteria

• Age: 44 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: collaborator
• California Dried Plum Board: collaborator
• United States Department of Agriculture (USDA): collaborator
• Penn State University: lead

Study Sites (1)

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

University Park, Pennsylvania, 16802, United States

RECRUITING

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Mary Jane De Souza, PhD

CONTACT

814-863-0045; mjd34@psu.edu

Nancy I. Williams, ScD

CONTACT

814-865-1346; niw1@psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Kinesiology and Physiology

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 13, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)