Prunes Preventing Bone Loss in Perimenopause

Conditions

• Perimenopausal Bone Loss

Eligibility Criteria

Sex

FEMALE

Age

44 Years - 55 Years

Healthy Volunteers

Accepted

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.

Study Details

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.

Key Dates

Start date

Dec 11, 2025

Status verified

Feb 2026

Primary completion

Sep 30, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

124 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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).

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

• Mary Jane De Souza, PhD
  814-863-0045
  [email protected]
• Nancy I. Williams, ScD
  814-865-1346
  [email protected]

Locations (1)

Find similar trials in University Park, PA