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

NCT ID: NCT04748250

Last Updated: 2021-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2021-02-20

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?

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.

Conditions

Osteoporosis, Osteopenia

Keywords

female athlete triad

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupuncture Group

This group will receive acupuncture therapy for 30 minutes, three times per week for six months using the internationally recognized standard acupuncture needle which is 3 cm long with diameter o.3 mm, pushing it with twisting movement to the required depth until the De Qi sensation will be obtained.

Group Type: EXPERIMENTAL

Acupuncture needles

Intervention Type: DEVICE

Standard acupuncture needle which is 3 cm long with diameter o.3 mm

Soy Group

This group will receive soy products for six months which including: Soy milk: 100 millilitre of soy milk every day, every bottle of original soy milk contains 300 millilitre or Soy beans: 100 gram of cooked soy beans per day.

Group Type: EXPERIMENTAL

Soy phytoestrogens

Intervention Type: DIETARY_SUPPLEMENT

100 millilitre of soy milk every day or 100 gram of cooked soy beans per day.

Acupuncture and Soy Group

Every patient in this group will receive acupuncture therapy sessions in abdominal acu-points as in group (A) for 30 minutes, three times per week for six months in addition to administration of soy products in the form of soy milk or soy beans daily in breakfast for three months as in group (B).

Group Type: EXPERIMENTAL

Acupuncture needles

Intervention Type: DEVICE

Standard acupuncture needle which is 3 cm long with diameter o.3 mm

Soy phytoestrogens

Intervention Type: DIETARY_SUPPLEMENT

100 millilitre of soy milk every day or 100 gram of cooked soy beans per day.

Interventions

Acupuncture needles

Standard acupuncture needle which is 3 cm long with diameter o.3 mm

Intervention Type: DEVICE

Soy phytoestrogens

100 millilitre of soy milk every day or 100 gram of cooked soy beans per day.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hend Reda Sakr

OTHER

Sponsor Role: lead

Responsible Party

Hend Reda Sakr

Principal investigator and Lecturer at Department of Physical Therapy for Woman's Health

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hend Reda, PhD

Role: STUDY_DIRECTOR

Badr University in Cairo

Locations

Faculty of Physical Therapy, Badr University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Hend1

Identifier Type: -

Identifier Source: org_study_id