Prune Consumption and Bone Health in Young Women Using Hormonal Contraceptives

San Diego State University

Status: Completed

Conditions: Osteoporosis Risk

Treatments: Other: Prune

Study type: Interventional

Funder types: Other

Identifiers

NCT04785131

59871A

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Prune group

Experimental group

Description:

Oral contraceptive users will consume 50 grams prunes daily.

Treatment:

Other: Prune

Oral contraceptive users

No Intervention group

Description:

Oral contraceptive users will be monitored throughout the study period.

Non oral contraceptive users

No Intervention group

Description:

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