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

Primary Purpose

Osteoporosis, Osteopenia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

dried plum

Calcium and vitamin D

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Prunes, dried plum, nutrition, bone

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)MaleAccepts 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.

Sites / Locations

School of Exercise and Nutritional Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dried plum (100 g dried plum)

Calcium and vitamin D

Arm Description

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

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

Outcomes

Primary Outcome Measures

Bone biomarkers

TRAP5b, BAP, CTX, P1NP

Secondary Outcome Measures

Bone mineral density

BMD by DXA

Full Information

NCT ID

NCT04720833

First Posted

January 15, 2021

Last Updated

January 20, 2021

Sponsor

San Diego State University

1. Study Identification

Unique Protocol Identification Number

NCT04720833

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

September 16, 2016 (Actual)

Primary Completion Date

September 10, 2019 (Actual)

Study Completion Date

December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

San Diego State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis, Osteopenia

Keywords

Prunes, dried plum, nutrition, bone

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Subjects will be randomly assign to one of the arms.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dried plum (100 g dried plum)

Arm Type

Experimental

Arm Description

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

Arm Title

Calcium and vitamin D

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

dried plum

Intervention Description

Dried plum

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium and vitamin D

Intervention Description

Calcium and vitamin D supplement

Primary Outcome Measure Information:

Title

Bone biomarkers

Description

TRAP5b, BAP, CTX, P1NP

Time Frame

changes from baseline to 3 months

Secondary Outcome Measure Information:

Title

Bone mineral density

Description

BMD by DXA

Time Frame

changes from baseline to 12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shirin Hooshmand, PhD, RD

Organizational Affiliation

San Diego State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Exercise and Nutritional Sciences

City

San Diego

State/Province

California

ZIP/Postal Code

92182

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34714130

Citation

Hooshmand S, Gaffen D, Eisner A, Fajardo J, Payton M, Kern M. Effects of 12 Months Consumption of 100 g Dried Plum (Prunes) on Bone Biomarkers, Density, and Strength in Men. J Med Food. 2022 Jan;25(1):40-47. doi: 10.1089/jmf.2021.0080. Epub 2021 Oct 29.

Results Reference

derived

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

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