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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04720833
Recruitment Status : Completed
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Shirin Hooshmand, San Diego State University

Study Description
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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
Osteoporosis Osteopenia Dietary Supplement: dried plum Dietary Supplement: Calcium and vitamin D Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : September 16, 2016
Actual Primary Completion Date : September 10, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Bone biomarkers [ Time Frame: changes from baseline to 3 months ]
    TRAP5b, BAP, CTX, P1NP


Secondary Outcome Measures :
  1. Bone mineral density [ Time Frame: changes from baseline to 12 months ]
    BMD by DXA


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04720833


Locations
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United States, California
School of Exercise and Nutritional Sciences
San Diego, California, United States, 92182
Sponsors and Collaborators
San Diego State University
Investigators
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Principal Investigator: Shirin Hooshmand, PhD, RD San Diego State University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shirin Hooshmand, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT04720833    
Other Study ID Numbers: 2521098
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shirin Hooshmand, San Diego State University:
Prunes
dried plum
nutrition
bone
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
 Calcium
Vitamins
Micronutrients
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents