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

NCT ID: NCT04547010

Last Updated: 2023-09-28

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

PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-12

Study Completion Date

2019-03-15

Brief Summary

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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

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Conditions

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Soy Isoflavone Effect Bone Density, Low Bone Density Increased

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Pre-post Quasi experimental study design.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Soy Isoflavone supplement

Intervention Type DIETARY_SUPPLEMENT

Participants received 60 mg of soy-isoflavone supplement per day.

Interventions

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Soy Isoflavone supplement

Participants received 60 mg of soy-isoflavone supplement per day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role lead

Responsible Party

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Tunny Sebastian

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Imam Abdulrahman Bin Faisal University

Dammam, Eastern Province, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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IRB-UGS-2018-03-273

Identifier Type: -

Identifier Source: org_study_id

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