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OpenTrials
Completed

NCT Number: NCT04785131

Prune Consumption and Bone Health in Young Women Using Hormonal Contraceptives

The primary objective of this study is to determine if 12 months of consuming 50 grams of dried plum daily will prevent bone loss or augment bone accrual of young adult oral contraceptive (OC) users.

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Key information

Conditions

Osteoporosis Risk

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

School of Exercise and Nutritional Sciences, San Diego, California, United States

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About this study

Eligible participants will be assigned among three groups 1) control non-OC users, 2) control OC users, and 3) dried plum OC users. OC users will be randomly allocated to the dried plum OC group, which will consume 50 g dried plum daily for 12 months, or a control group, for which dried plums will not be allowed and no control food will be provided.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-25

Exclusion criteria

  • Metabolic bone disease, renal disease, cancer, CVD, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease or other chronic diseases, heavy smoking (more than twenty cigarettes/day) and current use of any prescription medications known to alter bone and calcium metabolism
  • Regularly consumed dried plum or prune juice

Treatment and study plan

Prune

Other

daily consumption of 50 grams prune.

Primary outcomes

  1. Changes in bone mineral density from baseline to 12 months

    Time frame: At baseline, at 12 months

    Bone density measurements with DXA

Secondary outcomes

  1. Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months

    Time frame: At baseline, at 6 months, at 12 months

    Bone biomarkers measurements with ELISA

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Official study title

The Impact of Consuming California Dried Plums on Bone Health of Young Women Using Hormonal Contraceptives

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 5, 2021
Registry last updated
Jan 8, 2025

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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