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

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?

Study Overview

• Status: Completed
• Conditions: Osteoporosis, Osteopenia
• Intervention / Treatment: Device: Acupuncture needles; Dietary supplement: Soy phytoestrogens

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11829
    • Faculty of Physical Therapy, Badr University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Acupuncture needles; Standard acupuncture needle which is 3 cm long with diameter o.3 mm
Experimental: 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.	Dietary supplement: Soy phytoestrogens; 100 millilitre of soy milk every day or 100 gram of cooked soy beans per day.
Experimental: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Mineral Density	DEXA(Dual-energy X-ray absorptiometry)	Six months

Collaborators and Investigators

• Sponsor: Hend Reda Sakr
• Investigators: Study Director: Hend Reda, PhD, Badr University in Cairo

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): February 20, 2021

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: female athlete triad
• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Feeding and Eating Disorders; Musculoskeletal Diseases; Bone Diseases; Relative Energy Deficiency in Sport; Osteoporosis; Bone Diseases, Metabolic; Female Athlete Triad Syndrome; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens, Non-Steroidal; Estrogens; Phytoestrogens
• Other Study ID Numbers: Hend1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No