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Dried Plums Prevent Inflammation And Improve Bone Health in Osteopenic Men

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ClinicalTrials.gov Identifier: NCT03408119
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Bahram Arjmandi, Florida State University

Brief Summary:
The goals of this study are 1) to investigate the extent to which dried plum improves bone health by measuring bone density (a measure of bone strength) of whole body, hip, and forearm, indicators of bone formation and bone breakdown, and 2) to determine the anti-inflammatory effects of dried plum by assessing biomarkers of inflammation. Additionally, relevant medical history and lifestyle variables will be recorded.

Condition or disease Intervention/treatment Phase
Osteoporosis, Osteopenia Dietary Supplement: Dried Plum Dietary Supplement: 800 IU vitamin D and 450mg elemental calcium Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dried Plums Prevent Inflammation And Improve Bone Health in Osteopenic Men
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Group A
100g daily dried plum consumption, plus 800 IU vitamin D and 450 mg elemental calcium
Dietary Supplement: Dried Plum
Dried plum fruit, 100g or 50g depending on treatment group randomized to

Dietary Supplement: 800 IU vitamin D and 450mg elemental calcium
Supplemental vitamin D and calcium to protect against further bone loss

Experimental: Group B
50g daily dried plum consumption, plus 800 IU vitamin D and 450 mg elemental calcium
Dietary Supplement: Dried Plum
Dried plum fruit, 100g or 50g depending on treatment group randomized to

Dietary Supplement: 800 IU vitamin D and 450mg elemental calcium
Supplemental vitamin D and calcium to protect against further bone loss

Placebo Comparator: Group C
800 IU vitamin D and 450 mg elemental calcium
Dietary Supplement: 800 IU vitamin D and 450mg elemental calcium
Supplemental vitamin D and calcium to protect against further bone loss




Primary Outcome Measures :
  1. Bone mineral density (spine) [ Time Frame: 1 year ]
    BMD of the lumbar (L1-L4) vertebrae


Secondary Outcome Measures :
  1. Bone mineral content (spine) [ Time Frame: 1 year ]
    BMC of the lumbar (L1-L4) vertebrae

  2. Bone mineral Density (other) [ Time Frame: 1 year ]
    BMD of the ulna, hip, and total body

  3. Bone Mineral Content (other) [ Time Frame: 1 year ]
    BMC of the ulna, hip, and total body



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men aged 55-80 with osteopenia in lumbar (L1-L4) vertebrae
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men, between the ages of 55 and 80, whose lumbar spine BMD t-score is between 0.1 and 2.5 SD below the mean will be included. Participants who are not on testosterone and/or other pharmacological agents known to affect bone, or who have initiated an exercise program within the past 12 months known to influence bone (e.g. resistance training exercise), will be enrolled in this proposed study.

Exclusion Criteria:

  • The subjects who will be recruited for the study should not be receiving endocrine (e.g. prednisone, other glucocorticoids) or neuroactive (e.g. dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism. Men who have initiated regular exercise regimens known to influence bone within the past 12 months prior to the study, e.g. resistance exercise training will also be excluded. Men whose BMD t-score at any site that falls below 2.5 SD of the mean will be excluded from the study. Furthermore, subjects treated with calcitonin, bisphosphonates, denosumab, raloxifene, anabolic agents, e.g. PTH and growth hormone, or steroids within a year prior to the start of the study will be excluded. In addition, subjects with metabolic bone disease, renal disease, cancer, cardiovascular disease, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease, or other chronic diseases will be excluded. Potential subjects with a body mass index (BMI) < 18 and > 40 will be excluded to avoid extremes in leanness/adiposity and to readily allow body composition assessment. If subjects smoke ≥ 20 cigarettes per day, they will be excluded. Also men who regularly consume dried plum or prune juice will not be accepted into the study.

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): NCT03408119


Locations
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United States, Florida
Florida State University Recruiting
Tallahassee, Florida, United States, 32306
Contact: Bahram Arjmandi, PhD    850-645-1517    barjmandi@fsu.edu   
Sponsors and Collaborators
Florida State University

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Responsible Party: Bahram Arjmandi, Dr. Bahram H. Arjmandi, PhD, RD, Florida State University
ClinicalTrials.gov Identifier: NCT03408119     History of Changes
Other Study ID Numbers: 2017-05648
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
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 Bahram Arjmandi, Florida State University:
prune
dried plum
osteoporosis
osteopenia
men

Additional relevant MeSH terms:
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Inflammation
Osteoporosis
Bone Diseases, Metabolic
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents