Dried Plums for Bone Health in Older Postmenopausal Women

Not Applicable

Completed

• Conditions: Bone Diseases, Metabolic
• Interventions: Other: Dried Plum

• Registration Number: NCT02325895
• Lead Sponsor: San Diego State University

Brief Summary

The objective of the investigators current study was to examine whether 50 g dried plum would be as effective as 100 g dried plum in reversing bone loss in osteopenic older postmenopausal women.

Detailed Description

Forty-five randomly assigned into one of three treatment groups: 1) 50g dried plum; 2) 100g dried plum; and 3) control (0g dried plum). All groups received 500mg calcium and 400 IU vitamin D as a daily supplement. Blood samples were collected at baseline, 3 and 6 months to assess biomarkers of bone turnover. Physical activity recall and 3-day food records were obtained at baseline, 3 and 6 months to examine physical activity and dietary confounders as potential covariates

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-12
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-24
• Last Update Submitted: 2014-12-24
• Study First Posted: 2014-12-25
• Last Update Posted: 2014-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• BMD t-score of L1-L4 between -1 to -2.5 standard deviation of the mean
• Age 65 to 79

Exclusion Criteria

• BMD t-score at any site fell below 2.5 standard deviation of the mean
• Subjects treated with calcitonin, bisphosphonates, raloxifene and/or anabolic agents such as parathyroid hormone and growth hormone, or steroids within three months before the start of the study
• Metabolic bone disease, renal disease, cancer, CVD, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases, heavy smoking (more than twenty cigarettes/day) and current use of any prescription medications known to alter bone and calcium metabolism
• Regularly consumed dried plum or prune juice were not included in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
100 g Dried plum/day	Dried Plum	Participants received 400IU of vitamin D and 500mg of calcium and 100g of dried plum daily for 6 months.
50 g Dried plum/day	Dried Plum	Participants received 400IU of vitamin D and 500mg of calcium and 50g of dried plum daily for 6 months.

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density	6 months

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in bone specific alkaline phosphatase at 3 months and 6 months	baseline, 3 months and 6 months