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

San Diego State University

Status

Enrolling

Conditions

Bone Disease, Metabolic

Treatments

Dietary Supplement: Prune

Study type

Interventional

Funder types

Other

Identifiers

NCT06184646

HS-2023-0243

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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