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NCT Number: NCT06184646

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

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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Key information

Conditions

Bone Disease, Metabolic Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University

San Diego, California, 92182-7251, United States

Location status: Recruiting

Location contact

Shirin Hooshmand, PhD, RD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prune

Dietary Supplement

30 g of prune/day

Primary outcomes

  1. Changes from baseline in bone mineral density at 12 and 24 months

    Time frame: Baseline, 12 months, and 24 months

    bone mineral density as assessed by dual energy x-ray absorptiometry

Secondary outcomes

  1. Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months

    Time frame: Baseline, 12 months, and 24 months

    bone specific alkaline phosphatase (BAP) as assessed with ELISA

  2. Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months

    Time frame: Baseline, 12 months, and 24 months

    tartrate acid phosphatase-5b (TRAP5b) as assessed with ELISA

Study contacts

Contact information is provided by the study sponsor or research team.

Shirin Hooshmand, PhD

CONTACT

[email protected]

619-594-6823

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Official study title

Effect of Calcium and Vitamin D Supplements and/or Prunes on Bone Health

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 28, 2023
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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