Effect of Dried Plum on Bone and Markers of Bone Status in Men

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-16

Study Completion Date

2019-12-15

Brief Summary

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The principal objective of this study is to examine whether the addition of 100 g dried plum to the diets of men, regardless of their bone status, positively influences their indices of bone turnover in comparison with their corresponding baseline values and the control regimen.

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Detailed Description

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To test the bone protective properties of dried plum, 66 men (50 to 79 years of age) will receive either 100 g dried plum/day or a control regimen for 12 months. Both groups will receive 500 mg calcium and 400 IU vitamin D daily.

Evaluation will be based on analyses of bone mineral density at baseline, 6 and 12-months and serum and urine markers of bone formation and resorption at baseline and 3, 6, and 12-months.

Conditions

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Osteoporosis Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomly assign to one of the arms.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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dried plum (100 g dried plum)

Participants will receive 100 g dried plum daily plus 500 mg calcium and 300 IU vitamin D daily

Group Type EXPERIMENTAL

dried plum

Intervention Type DIETARY_SUPPLEMENT

Dried plum

Calcium and vitamin D

Participants will receive 500 mg calcium and 300 IU vitamin D daily

Group Type PLACEBO_COMPARATOR

Calcium and vitamin D

Intervention Type DIETARY_SUPPLEMENT

Calcium and vitamin D supplement

Interventions

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dried plum

Dried plum

Intervention Type DIETARY_SUPPLEMENT

Calcium and vitamin D

Calcium and vitamin D supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy men (50-79 year-old)

Exclusion Criteria

* endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
* Men whose BMD t-score at any site falls below 2.5 SD of the mean will be excluded from the study and referred to their primary care physician
* subjects treated with calcitonin, bisphosphonates, raloxifene, sodium fluoride, anabolic agents, e.g. PTH and growth hormone, or steroids for less than 3 months prior to the start of the study will be excluded.
* body mass index (BMI) \<18 and \>30 will be excluded to avoid extremes in leanness/adiposity and to readily allow body composition assessment.
* If subjects smoke 20 cigarettes or more per day, they will be excluded.
* Men who regularly consume dried plum or prune juice will not be accepted into the study.

Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes