Dried Plums for Bone Health in Older Postmenopausal Women

Bone Diseases, Metabolic Clinical Trial

Official title:

Effect of Dried Plum on Bone and Bone Biomarkers in Older Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325895
• Other study ID #: 57114A
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: December 24, 2014
• Start date: August 2012
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Metabolic Diseases

Intervention

Other:
• Dried Plum
Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	Florida State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density		6 months	No
Secondary	Changes from baseline in bone specific alkaline phosphatase at 3 months and 6 months		baseline, 3 months and 6 months	No