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

Not Applicable

Completed

• Conditions: Osteoporosis, Osteopenia
• Interventions: Device: Acupuncture needles; Dietary Supplement: Soy phytoestrogens

• Registration Number: NCT04748250
• Lead Sponsor: Hend Reda Sakr

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.

Study Timeline

• Study Start: 2020-07-20
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-09
• Primary Completion: 2021-02-10
• Study First Posted: 2021-02-10
• Study Completion: 2021-02-20
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Acupuncture Group	Acupuncture needles	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.
Acupuncture and Soy Group	Acupuncture needles	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).
Acupuncture and Soy Group	Soy phytoestrogens	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).
Soy Group	Soy phytoestrogens	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.

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density	Six months	DEXA(Dual-energy X-ray absorptiometry)

Trial Locations

Locations (1)

Faculty of Physical Therapy, Badr University; 🇪🇬 Cairo, Egypt