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OpenTrials
Completed

NCT Number: NCT04720833

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

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.

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Key information

Age range

50 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

School of Exercise and Nutritional Sciences

San Diego, California, 92182, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dried Plum

Dietary Supplement

Dried plum

Calcium and Vitamin D

Dietary Supplement

Calcium and vitamin D supplement

Primary outcomes

  1. Bone biomarkers

    Time frame: changes from baseline to 3 months

    TRAP5b, BAP, CTX, P1NP

Secondary outcomes

  1. Bone mineral density

    Time frame: changes from baseline to 12 months

    BMD by DXA

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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