Effect of Soy Phytoestrogens and Acupuncture on Bone Mineral Density in Female Athlete Triad at Adolescence Age

Osteoporosis, Osteopenia Clinical Trial

Official title:

Effect of Soy Phytoestrogens and Acupuncture on Bone Mineral Density in Female Athlete Triad at Adolescence Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04748250
• Other study ID #: Hend1
• Status: Completed
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: February 20, 2021

Study information

• Verified date: November 2021
• Source: Badr University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 20, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

All girls diagnosed with female athlete triad resulting in osteopenia

• Their age between 14-18 years old

• Their body mass index is less than 5 percent according to the gross motor chart

• All participants are gymnastics players

• All are medically stable

• They will be able to follow instructions

Exclusion Criteria:

• Marriage

• Pregnancy

• Taking any hormonal treatment

• Receiving any other form of traditional physical therapy modalities

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteoporosis
• Osteoporosis, Osteopenia

Intervention

Device:
• Acupuncture needles
Standard acupuncture needle which is 3 cm long with diameter o.3 mm

Dietary Supplement:
• Soy phytoestrogens
100 millilitre of soy milk every day or 100 gram of cooked soy beans per day.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy, Badr University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Hend Reda Sakr

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density	DEXA(Dual-energy X-ray absorptiometry)	Six months