Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04785131
Other study ID # 59871A
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 30, 2019
Est. completion date December 30, 2024

Study information

Verified date December 2023
Source San Diego State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date December 30, 2024
Est. primary completion date October 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Prune
daily consumption of 50 grams prune.

Locations

Country Name City State
United States School of Exercise and Nutritional Sciences San Diego California
United States Shirin Hooshmand San Diego California

Sponsors (1)

Lead Sponsor Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in bone mineral density from baseline to 12 months Bone density measurements with DXA At baseline, at 12 months
Secondary Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months Bone biomarkers measurements with ELISA At baseline, at 6 months, at 12 months
See also
  Status Clinical Trial Phase
Completed NCT03710889 - Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption Phase 3
Not yet recruiting NCT05738785 - Risk of Osteoporotic Fracture in Home Care Patients in Turkey
Recruiting NCT03337971 - Nutritional Supplement and Bone Health in Post-Menopausal Women N/A
Completed NCT03701113 - Milk Protein and Bone Health in Postmenopausal Women N/A
Completed NCT05760651 - Awareness of Osteoporosis in Multiple Sclerosis Patients
Active, not recruiting NCT04472286 - Healthy Bones, Healthy Life: Habitual Physical Activity on Bone & Metabolic Health in Pediatric Cancer Survivors
Completed NCT05245097 - Mitigation of Major Hip Injury Due to Fall With a Smart Belt N/A
Completed NCT05881850 - Education Program on Increasing Osteoporosis Awareness Given to Women Aged 18-49 N/A
Completed NCT05854342 - Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis N/A
Recruiting NCT05903820 - Rhythmic Estradiol and Bone Health Phase 4
Completed NCT05197244 - A Culinary Intervention for Bone Health N/A
Not yet recruiting NCT05769400 - Awareness of Osteoporosis in Patients With Hepatitis C Infection
Not yet recruiting NCT05760118 - Awareness of Osteoporosis in Diabetes Mellitus Patients
Not yet recruiting NCT05760131 - Awareness of Osteoporosis in Patients With Hypothyroidism
Completed NCT05721898 - Assessment of Cortical Bone Mechanics Technology (CBMT) Fracture Discrimination Capability
Completed NCT06081764 - Investigation of the Effects of Physical Activity in Women at Risk of Osteoporosis N/A
Not yet recruiting NCT05678569 - OsteoPorosis Treatment Identification Using Machine Learning
Active, not recruiting NCT04565743 - Stop At One Stockholm (SAOS)- Secondary Fracture Prevention Through Active Patient Identification and Staff Education. N/A
Recruiting NCT06279078 - Long-term Effect of Steroid on Metabolic Diseases in Asthmatics
Not yet recruiting NCT05760105 - Awareness of Osteoporosis in Ankylosing Spondylosis Patients