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Clinical Trials/NCT04547010
NCT04547010CompletedPhase 3

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

Imam Abdulrahman Bin Faisal University1 site in 1 country28 target enrollmentStarted: December 12, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
28
Locations
1
Primary Endpoint
Bone Mineral Density (BMD)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Arms & Interventions

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.

Intervention: Soy Isoflavone supplement (Dietary Supplement)

Outcomes

Primary Outcomes

Bone Mineral Density (BMD)

Time Frame: 4 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tunny Sebastian

Assistant Professor

Imam Abdulrahman Bin Faisal University

Study Sites (1)

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