Postmenopausal Osteoporosis Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 44
Maximum Age: 55
Healthy Volunteers: t
View:

• 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

Locations
United States
Pennsylvania
Women's Health and Exercise Laboratory, The Pennsylvania State University
RECRUITING
University Park
Contact Information
Primary
Mary Jane De Souza, PhD
mjd34@psu.edu
814-863-0045
Backup
Nancy I. Williams, ScD
niw1@psu.edu
814-865-1346
Time Frame
Start Date: 2025-12-11
Estimated Completion Date: 2029-12
Participants
Target number of participants: 124
Treatments
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).
Sponsors
Collaborators: United States Department of Agriculture (USDA), University of Georgia, California Dried Plum Board
Leads: Penn State University

This content was sourced from clinicaltrials.gov