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RECRUITING
NCT07120997
NA

Prunes Preventing Bone Loss in Perimenopause

Sponsor: Penn State University

View on ClinicalTrials.gov

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.

Official title: A Prevention Strategy for the Indication of Prune Consumption in Perimenopausal Females: Can Prunes Attenuate Bone Loss?

Key Details

Gender

FEMALE

Age Range

44 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-12-11

Completion Date

2029-12

Last Updated

2026-02-04

Healthy Volunteers

Yes

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.

Locations (1)

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

University Park, Pennsylvania, United States