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

NCT04720833 | Completed

• 1 other identifier: 2521098
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Osteopenia

Keywords

Prunes; dried plum; nutrition; bone

Outcome Measures

Primary Outcomes (1)

• Bone biomarkers

  TRAP5b, BAP, CTX, P1NP

  changes from baseline to 3 months

Secondary Outcomes (1)

• Bone mineral density

  changes from baseline to 12 months

Study Arms (2)

dried plum (100 g dried plum)

EXPERIMENTAL

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

Dietary Supplement: dried plum

Calcium and vitamin D

PLACEBO COMPARATOR

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

Dietary Supplement: Calcium and vitamin D

Interventions

dried plum DIETARY_SUPPLEMENT

Dried plum

dried plum (100 g dried plum)

Calcium and vitamin D DIETARY_SUPPLEMENT

Calcium and vitamin D supplement

Calcium and vitamin D

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men (50-79 year-old)

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (1)

School of Exercise and Nutritional Sciences

San Diego, California, 92182, United States

Location

Related Publications (1)

• 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.

  PMID: 34714130 DERIVED

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Interventions

Calcium; Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Shirin Hooshmand, PhD, RD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects will be randomly assign to one of the arms.

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 22, 2021
• Study Start: September 16, 2016
• Primary Completion: September 10, 2019
• Study Completion: December 15, 2019
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)