Dried Plums Prevent Inflammation And Improve Bone Health in Osteopenic Men

NCT03408119 | Completed

• 1 other identifier: 2017-05648
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis, Osteopenia

Keywords

prune; dried plum; osteoporosis; osteopenia; men

Outcome Measures

Primary Outcomes (1)

• Bone mineral density (spine)

  BMD of the lumbar (L1-L4) vertebrae

  1 year

Secondary Outcomes (3)

• Bone mineral content (spine)

  1 year

• Bone mineral Density (other)

  1 year

• Bone Mineral Content (other)

  1 year

Study Arms (3)

Group A

EXPERIMENTAL

100g daily dried plum consumption, plus 800 IU vitamin D and 450 mg elemental calcium

Dietary Supplement: Dried Plum; Dietary Supplement: 800 IU vitamin D and 450mg elemental calcium

Group B

EXPERIMENTAL

50g daily dried plum consumption, plus 800 IU vitamin D and 450 mg elemental calcium

Dietary Supplement: Dried Plum; Dietary Supplement: 800 IU vitamin D and 450mg elemental calcium

Group C

PLACEBO COMPARATOR

800 IU vitamin D and 450 mg elemental calcium

Dietary Supplement: 800 IU vitamin D and 450mg elemental calcium

Interventions

Dried Plum DIETARY_SUPPLEMENT

Dried plum fruit, 100g or 50g depending on treatment group randomized to

Group A; Group B

800 IU vitamin D and 450mg elemental calcium DIETARY_SUPPLEMENT

Supplemental vitamin D and calcium to protect against further bone loss

Group A; Group B; Group C

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: Men aged 55-80 with osteopenia in lumbar (L1-L4) vertebrae
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Multiple Endocrine Neoplasia Type 1

Interventions

Vitamin D; Calcium

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

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: Dr. Bahram H. Arjmandi, PhD, RD

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 23, 2018
• Study Start: November 20, 2017
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)