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

• ClinicalTrials.gov Identifier: NCT04748250
• Recruitment Status: Completed
• First Posted: February 10, 2021
• Last Update Posted: November 10, 2021
• Sponsor: Hend Reda Sakr
• Information provided by (Responsible Party): Hend Reda Sakr, Badr University

Study Description

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?

Condition or disease	Intervention/treatment	Phase
Osteoporosis, Osteopenia	Device: Acupuncture needles; Dietary Supplement: Soy phytoestrogens	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Soy Phytoestrogens and Acupuncture on Bone Mineral Density in Female Athlete Triad at Adolescence Age
• Actual Study Start Date: July 20, 2020
• Actual Primary Completion Date: February 10, 2021
• Actual Study Completion Date: February 20, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Bone Mineral Density [ Time Frame: Six months ]
   DEXA(Dual-energy X-ray absorptiometry)

Eligibility Criteria

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

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

Contacts and Locations

Locations

Egypt

Faculty of Physical Therapy, Badr University

Cairo, Egypt, 11829

Sponsors and Collaborators

Hend Reda Sakr

Investigators

• Study Director: Hend Reda, PhD; Badr University in Cairo

More Information

• Responsible Party: Hend Reda Sakr, Principal investigator and Lecturer at Department of Physical Therapy for Woman's Health, Badr University
• ClinicalTrials.gov Identifier: NCT04748250
• Other Study ID Numbers: Hend1
• First Posted: February 10, 2021
• Last Update Posted: November 10, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hend Reda Sakr, Badr University:

female athlete triad

Additional relevant MeSH terms:

Osteoporosis; Bone Diseases, Metabolic; Female Athlete Triad Syndrome; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Relative Energy Deficiency in Sport; Feeding and Eating Disorders; Mental Disorders; Phytoestrogens; Estrogens, Non-Steroidal; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs