Prunes Preventing Bone Loss in Perimenopause

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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Females spend at least one-third of their lifespan after menopause, therefore strategies that improve the long-term health of women and engage a prevention strategy to improve health are warranted and represent opportunities for high impact and high return on investment. After menopause, one in two females will suffer a fragility fracture in their lifetime, and the mortality rate after a hip fracture is as high as 25%. Moreover, since osteoporosis-related treatment costs more than $100 billion worldwide, strategies that focus on the prevention of osteoporosis-related fragility fractures are warranted. As such, the prevention of bone loss, osteoporosis, and its related fractures is much preferred over treatment of osteoporosis given the high costs, negative side effects, and poor compliance to pharmacological treatment regimens. Therefore, research addressing the optimization of the health of perimenopausal females to delay chronic disease is very much necessary and represents the overall objective of this project. Given the high mortality rate of hip fractures, this intervention may potentially save people's lives while reducing a significant healthcare burden.

The long-term goal of this project is to change the course of bone loss during a very specific and opportunistic intervention window, i.e., the transmenopausal window. This window of intervention is opportunistic because females lose more bone at the hip and spine than at any other time; that is, as much as 6% and 7% at the hip and spine, respectively. In fact, the amount of bone loss during this three-year transmenopausal window that initiates late perimenopause is greater than the amount of bone loss observed during the postmenopause window, when the latter is defined as 2 to 5 years after the final menstrual period. The STRAW+10 investigators defined the stages of menopause, including the transmenopause period, a stage in life that is associated with dramatic bone loss. As such, this project is novel, innovative, and can potentially delay the serious effects of osteoporotic bone loss and associated fractures, to which transmenopausal bone loss significantly contributes. When one considers that as of 2021, there were approximately 1.02 billion females over 50 years of age worldwide, with an estimated 1.2 billion females over the age of 50 by 2030, accounting for 26% of all females worldwide, the potential impact of this project is substantial. Indeed, this project may affect the long-term picture of bone health for millions of females by delaying or attenuating the acceleration of bone loss during the transmenopause period. Moreover, since osteoporosis affects millions of females worldwide, this project has the potential to offset the devasting long-term effects of accelerated bone loss during transmenopause that is associated with osteoporosis.

The overall objective of this research is to test whether prunes are effective in attenuating the rapid transmenopausal bone loss observed in late peri and early postmenopausal females. The investigators will study the effects of 18 months of prune consumption in females recruited during the late peri and early postmenopausal stage, allowing a high probability for data collection spanning the transmenopausal period of heightened bone loss, i.e., 12 months before the final menstrual period and the two years following the final menstrual period. The investigators will also examine the physiological mechanisms underlying the bone trophic effects of prune consumption to seek evidence on how prunes work. If successful, prunes will be demonstrated to be a powerful strategy to attenuate and delay the rapid decline in bone mineral density and decrements in microarchitecture that eventually lead to osteoporosis and heightened risk for fracture.

Conditions

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Perimenopausal Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL