Prunes Preventing Bone Loss in Perimenopause

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

Interventions

DIETARY_SUPPLEMENT

Prunes

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

DIETARY_SUPPLEMENT

Calcium supplement

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

DIETARY_SUPPLEMENT

Vitamin D Supplement

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

Sponsors & Collaborators

• University of Georgia

  collaborator OTHER

• California Dried Plum Board

  collaborator OTHER

• United States Department of Agriculture (USDA)

  collaborator FED

• Penn State University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

44 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-11

Primary Completion

2029-09-30

Completion

2029-12-31

Countries

• United States

Study Locations