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

NCT04547010 | Completed Phase 3

• 1 other identifier: IRB-UGS-2018-03-273
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Soy Isoflavone Effect; Bone Density, Low; Bone Density Increased

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density (BMD)

  4 weeks

Study Arms (1)

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

Soy Isoflavone supplement DIETARY_SUPPLEMENT

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female
• University students
• aged between 18-25 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

Imam Abdulrahman Bin Faisal University

Dammam, Eastern Province, 34221, Saudi Arabia

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteosclerosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Osteochondrodysplasias; Bone Diseases, Developmental

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pre-post Quasi experimental study design.

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 14, 2020
• Study Start: December 12, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)