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

NCT04720833•San Diego State University

Summary

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.

Detailed Description

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.

Eligibility

Age

50 - 79 years

Sex

MALE

Healthy Volunteers

Yes

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.

Locations (1)

School of Exercise and Nutritional Sciences

San Diego, California, United States

Key Dates

Start Date

September 16, 2016

Primary Completion Date

September 10, 2019

Completion Date

December 15, 2019

Last Updated

January 22, 2021

Enrollment

ACTUAL participants

Conditions

OsteoporosisOsteopenia

Interventions

dried plum

DIETARY_SUPPLEMENT

Calcium and vitamin D

DIETARY_SUPPLEMENT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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