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

San Diego State University

Status: Completed

Conditions: Osteopenia; Osteoporosis

Treatments: Dietary Supplement: Calcium and vitamin D; Dietary Supplement: dried plum

Study type: Interventional

Funder types: Other

Identifiers

NCT04720833

2521098

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: Male

Ages: 50 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups, including a placebo group

dried plum (100 g dried plum)

Experimental group

Description:

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

Treatment:

Dietary Supplement: dried plum

Calcium and vitamin D

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Calcium and vitamin D