Prune Consumption and Bone Health in Young Women Using Hormonal Contraceptives

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2024-12-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Osteoporosis Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Prune group

Oral contraceptive users will consume 50 grams prunes daily.

Group Type EXPERIMENTAL

Prune

Intervention Type OTHER

daily consumption of 50 grams prune.

Oral contraceptive users

Oral contraceptive users will be monitored throughout the study period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Non oral contraceptive users

Non oral contraceptive users will be monitored throughout the study period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prune

daily consumption of 50 grams prune.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes