Back to resultsEffects of Soy Isoflavone on Bone Health Among Saudi Female Students Imam Abdulrahman Bin Faisal University.
Primary Purpose
Soy Isoflavone Effect, Bone Density, Low, Bone Density Increased
Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Soy Isoflavone supplement
Sponsored by
About this trial
This is an interventional prevention trial for Soy Isoflavone Effect
Eligibility Criteria
Inclusion Criteria:
- female
- University students
- aged between 18-25 years
Exclusion Criteria:
- Study participants who use medications and suffer from diseases that may interfere or effect on BMD, use calcium and vitamin D supplements and who suffer from glucose 6 phosphate deficiency (G6PD) were excluded from the study.
Sites / Locations
- Imam Abdulrahman Bin Faisal University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
In four weeks of intervention study the participants instructed to receive (60 mg) of soy-isoflavone supplement per day, after this period the Bone Mineral Density was assessed by Dual X-ray Absorptiometry scan to evaluate the effect of soy-isoflavone supplement on Bone mineral density.
Outcomes
Primary Outcome Measures
Bone Mineral Density (BMD)
Secondary Outcome Measures
Full Information
NCT ID
NCT04547010
First Posted
September 6, 2020
Last Updated
September 26, 2023
Sponsor
Imam Abdulrahman Bin Faisal University
1. Study Identification
Unique Protocol Identification Number
NCT04547010
Brief Title
Effects of Soy Isoflavone on Bone Health Among Saudi Female Students Imam Abdulrahman Bin Faisal University.
Official Title
Effects of Soy Isoflavone on Bone Health Among Saudi Female Students Imam Abdulrahman Bin Faisal University.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Low bone mineral density (BMD) has recently increased among young women. Soy Isoflavone as a food supplement, has been found to have potent effect on bone health in postmenopausal women. However, the effect of soy isoflavone on pre-menopausal is not well understood. This research is done to examine the effect of soy isoflavones on BMD among young university female students.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soy Isoflavone Effect, Bone Density, Low, Bone Density Increased
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Pre-post Quasi experimental study design.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
In four weeks of intervention study the participants instructed to receive (60 mg) of soy-isoflavone supplement per day, after this period the Bone Mineral Density was assessed by Dual X-ray Absorptiometry scan to evaluate the effect of soy-isoflavone supplement on Bone mineral density.
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy Isoflavone supplement
Intervention Description
Participants received 60 mg of soy-isoflavone supplement per day.
Primary Outcome Measure Information:
Title
Bone Mineral Density (BMD)
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
female
University students
aged between 18-25 years
Exclusion Criteria:
Study participants who use medications and suffer from diseases that may interfere or effect on BMD, use calcium and vitamin D supplements and who suffer from glucose 6 phosphate deficiency (G6PD) were excluded from the study.
Facility Information:
Facility Name
Imam Abdulrahman Bin Faisal University
City
Dammam
State/Province
Eastern
ZIP/Postal Code
34221
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Soy Isoflavone on Bone Health Among Saudi Female Students Imam Abdulrahman Bin Faisal University.
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