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

Sponsor
San Diego State University (Other)
Overall Status
Completed
CT.gov ID
NCT04720833
Collaborator
(none)
66
1
2
38.9
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: dried plum
  • Dietary Supplement: Calcium and vitamin D
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Subjects will be randomly assign to one of the arms.Subjects will be randomly assign to one of the arms.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of Dried Plum on Bone and Markers of Bone Status in Men
Actual Study Start Date :
Sep 16, 2016
Actual Primary Completion Date :
Sep 10, 2019
Actual Study Completion Date :
Dec 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: dried plum (100 g dried plum)

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

Dietary Supplement: dried plum
Dried plum

Placebo Comparator: Calcium and vitamin D

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

Dietary Supplement: Calcium and vitamin D
Calcium and vitamin D supplement

Outcome Measures

Primary Outcome Measures

  1. Bone biomarkers [changes from baseline to 3 months]

    TRAP5b, BAP, CTX, P1NP

Secondary Outcome Measures

  1. Bone mineral density [changes from baseline to 12 months]

    BMD by DXA

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 79 Years
Sexes Eligible for Study:
Male
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Exercise and Nutritional Sciences San Diego California United States 92182

Sponsors and Collaborators

  • San Diego State University

Investigators

  • Principal Investigator: Shirin Hooshmand, PhD, RD, San Diego State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shirin Hooshmand, Professor, San Diego State University
ClinicalTrials.gov Identifier:
NCT04720833
Other Study ID Numbers:
  • 2521098
First Posted:
Jan 22, 2021
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shirin Hooshmand, Professor, San Diego State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 22, 2021