Effects of Soy Isoflavone on Bone Health Among Saudi Fema... | NCT04547010

Studies
Effects of Soy Isoflavone on Bone Health Among Saudi Female Students Imam Abdulrahman Bin Faisal University.

NCT04547010

Sponsor

Imam Abdulrahman Bin Faisal University

Status

Completed

Last Update Posted

Sep 28, 2023Actual

Enrollment

28Actual

Phase

Phase 3

Conditions

Soy Isoflavone Effect
Bone Density, Low
Bone Density Increased

Interventions

Soy Isoflavone supplement

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2018Actual

Primary Completion Date

Mar 15, 2019Actual

Completion Date

Mar 15, 2019Actual

First Submitted Date

Sep 6, 2020

First Submission Date that Met QC Criteria

Sep 6, 2020

First Posted Date

Sep 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2023

Last Update Posted Date

Sep 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tunny Sebastian, Assistant Professor, Imam Abdulrahman Bin Faisal UniversityPrincipal Investigator

Lead Sponsor

Imam Abdulrahman Bin Faisal UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	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.	Dietary Supplement: Soy Isoflavone supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Soy Isoflavone supplement	Dietary Supplement	Participants received 60 mg of soy-isoflavone supplement per day.	Intervention group

Measure	Description	Time Frame
Bone Mineral Density (BMD)		4 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imam Abdulrahman Bin Faisal University		Dammam	Eastern Province	34221	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001851	Bone Diseases, Metabolic
D010026	Osteosclerosis

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided