Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 7:50 PM
Study NCT ID:
NCT04748250
Status:
COMPLETED
Last Update Posted:
2021-11-10
First Post:
2021-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Soy Phytoestrogens and Acupuncture on Bone Mineral Density in Female Athlete Triad at Adolescence Age
Sponsor:
Hend Reda Sakr
Organization:
Study Overview
Official Title:
Effect of Soy Phytoestrogens and Acupuncture on Bone Mineral Density in Female Athlete Triad at Adolescence Age
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study to determine the effect of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. It is hypothesized that:
\- There will be no statistical significant difference between the effects of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. RESEARCH QUESTION: Do soy phytoestrogens and acupuncture have an effect on bone mineral density in female athlete triad at adolescence age?
\- There will be no statistical significant difference between the effects of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. RESEARCH QUESTION: Do soy phytoestrogens and acupuncture have an effect on bone mineral density in female athlete triad at adolescence age?
Detailed Description:
Many female athletes don't depend only on physical training and exercising to obtain the ideal slim and thin body. So that they follow harmful unhealthy diet to achieve the ideal body shape they are seeking. These types of diet can lead to malnutrition, menstrual disturbances, and bone loss, and these three components form a triad called female athlete triad. A limited number of studies have examined the effect of acupuncture and soy products on irregularities related to female athletes so the aim of this study is to investigate the effect of both acupuncture in line with diet modification using soy products on osteopenia in female athlete triad. Study Design: A prospective, randomized, single-blind, pre-post-test, controlled trial.
Sixty female athletes with ages ranged from 14 to 18 years, playing gymnastics and all diagnosed and referred with female athlete triad resulting in decreased bone mineral density and osteoporosis. All participants will be treated with soy products and acupuncture and will be closely followed for six months. DEXA will be used to assess bone mineral density before and after the treatment program.
Sixty female athletes with ages ranged from 14 to 18 years, playing gymnastics and all diagnosed and referred with female athlete triad resulting in decreased bone mineral density and osteoporosis. All participants will be treated with soy products and acupuncture and will be closely followed for six months. DEXA will be used to assess bone mineral density before and after the treatment program.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: