Elucidating the Minimal Effective Dose of Prunes for Bone Health in Postmenopausal Women

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

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2028-12-31

Brief Summary

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The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.

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Detailed Description

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Two hundred randomly assigned to one of two treatment groups: 1) 30 g prunes and 2) control (0 g prunes). Both groups received 500 mg calcium and 400 IU Vitamin D as a daily supplement. Blood samples are collected at baseline, 12 and 24 months to assess biomarkers of bone turnover. Physical activity recall and food records are obtained at baseline, 12 and 24 months to examine physical activity and dietary confounders as potential covariates. Dual-energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) will be completed at baseline, 12 and 24 months to examine bone mineral density and structure.

Conditions

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Bone Disease, Metabolic

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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Control (0 g prune/day)

Participants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

30 g prune/day

Participants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months.

Group Type EXPERIMENTAL

Prune

Intervention Type DIETARY_SUPPLEMENT

30 g of prune/day

Interventions

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Prune

30 g of prune/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal
* BMD t-score is between 0.5 and 2 SD below the mean
* Not on hormone replacement therapy (HRT) and/or other pharmacological agents known to affect bone for at least three months prior to initiation of the study

Exclusion Criteria

* Women whose BMD t-score at any site falls below 2.5 SD of the mean
* Subjects receiving endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
* Subjects who smoke cigarettes or vape
* Regular consumption of dried plum or prune juice

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No