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

Not Applicable

Completed

• Conditions: Osteoporosis; Osteopenia
• Interventions: Dietary Supplement: dried plum; Dietary Supplement: Calcium and vitamin D

• Registration Number: NCT04720833
• Lead Sponsor: San Diego State University

Brief 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.

Study Timeline

• Study Start: 2016-09-16
• Primary Completion: 2019-09-10
• Study Completion: 2019-12-15
• Status Verified: 2021-01
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-20
• Last Update Submitted: 2021-01-20
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dried plum (100 g dried plum)	dried plum	Participants will receive 100 g dried plum daily plus 500 mg calcium and 300 IU vitamin D daily
Calcium and vitamin D	Calcium and vitamin D	Participants will receive 500 mg calcium and 300 IU vitamin D daily

Primary Outcome Measures

Name	Time	Method
Bone biomarkers	changes from baseline to 3 months	TRAP5b, BAP, CTX, P1NP

Secondary Outcome Measures

Name	Time	Method
Bone mineral density	changes from baseline to 12 months	BMD by DXA

Trial Locations

Locations (1)

School of Exercise and Nutritional Sciences; 🇺🇸 San Diego, California, United States