Elucidating the Minimal Effective Dose of Prunes for Bone Health in Postmenopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prune.
- Who it may be relevant to
- Registry conditions: Bone Disease, Metabolic. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Calcium and Vitamin D Supplements and/or Prunes on Bone Health
Overview
The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.
Detailed description
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.
Interventions
- Dietary supplement Prune
30 g of prune/day
Primary outcome measures
- Changes from baseline in bone mineral density at 12 and 24 months [Time frame: Baseline, 12 months, and 24 months]
Secondary outcome measures (2)
- Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months [Time frame: Baseline, 12 months, and 24 months]
- Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months [Time frame: Baseline, 12 months, and 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- San Diego State University — San Diego
Identifiers
NCT: NCT06184646 · HS-2023-0243