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

N/ACompletedNCT04720833

San Diego State University66 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Osteoporosis Osteopenia

Interventions

dried plumDIETARY_SUPPLEMENT

Dried plum

Calcium and vitamin DDIETARY_SUPPLEMENT

Calcium and vitamin D supplement

Eligibility

Sex: MALEMin age: 50 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bone biomarkers

TRAP5b, BAP, CTX, P1NP

Time frame: changes from baseline to 3 months

Secondary Outcomes

Bone mineral density

BMD by DXA

Time frame: changes from baseline to 12 months

Data from ClinicalTrials.gov

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