Dried Plums for Bone Health in Older Postmenopausal Women

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Bone Diseases, Metabolic

Intervention / Treatment
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* Other: Dried Plum


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (0 g Dried plum/day)<br>Participants only received 400IU of vitamin D and 500mg of calcium daily for 6 months. | |
| Experimental: 50 g Dried plum/day<br>Participants received 400IU of vitamin D and 500mg of calcium and 50g of dried plum daily for 6 months. | Other: Dried Plum<br>* Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.<br>|
| Experimental: 100 g Dried plum/day<br>Participants received 400IU of vitamin D and 500mg of calcium and 100g of dried plum daily for 6 months. | Other: Dried Plum<br>* Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in bone specific alkaline phosphatase at 3 months and 6 months |  | baseline, 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Dried plum, functional food