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

Bone Disease, Metabolic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184646
• Other study ID #: HS-2023-0243
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: San Diego State University
• Contact: Shirin Hooshmand, PhD
• Phone: 619-594-6823
• Email: shooshmand[@]sdsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Disease, Metabolic
• Bone Diseases
• Bone Diseases, Metabolic
• Metabolic Diseases

Intervention

Dietary Supplement:
• Prune
30 g of prune/day

Locations

Country	Name	City	State
United States	San Diego State University	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in bone mineral density at 12 and 24 months	bone mineral density as assessed by dual energy x-ray absorptiometry	Baseline, 12 months, and 24 months
Secondary	Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months	bone specific alkaline phosphatase (BAP) as assessed with ELISA	Baseline, 12 months, and 24 months
Secondary	Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months	tartrate acid phosphatase-5b (TRAP5b) as assessed with ELISA	Baseline, 12 months, and 24 months