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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720833
• Other study ID #: 2521098
• Status: Completed
• Phase: N/A
• Start date: September 16, 2016
• Est. completion date: December 15, 2019

Study information

• Verified date: January 2021
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 15, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis

Intervention

Dietary Supplement:
• dried plum
Dried plum
• Calcium and vitamin D
Calcium and vitamin D supplement

Locations

Country	Name	City	State
United States	School of Exercise and Nutritional Sciences	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone biomarkers	TRAP5b, BAP, CTX, P1NP	changes from baseline to 3 months
Secondary	Bone mineral density	BMD by DXA	changes from baseline to 12 months