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

Primary Purpose

Osteoporosis, Osteopenia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Acupuncture needles
Soy phytoestrogens
Sponsored by
Hend Reda Sakr
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis, Osteopenia focused on measuring female athlete triad

Eligibility Criteria

14 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Physical Therapy, Badr University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Acupuncture Group

Soy Group

Acupuncture and Soy Group

Arm Description

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.

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.

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).

Outcomes

Primary Outcome Measures

Bone Mineral Density
DEXA(Dual-energy X-ray absorptiometry)

Secondary Outcome Measures

Full Information

First Posted
February 4, 2021
Last Updated
November 3, 2021
Sponsor
Hend Reda Sakr
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1. Study Identification

Unique Protocol Identification Number
NCT04748250
Brief Title
Effect of Soy Phytoestrogens and Acupuncture on Bone Mineral Density in Female Athlete Triad at Adolescence Age
Official Title
Effect of Soy Phytoestrogens and Acupuncture on Bone Mineral Density in Female Athlete Triad at Adolescence Age
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hend Reda Sakr

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia
Keywords
female athlete triad

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Soy Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Acupuncture and Soy Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Acupuncture needles
Intervention Description
Standard acupuncture needle which is 3 cm long with diameter o.3 mm
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy phytoestrogens
Intervention Description
100 millilitre of soy milk every day or 100 gram of cooked soy beans per day.
Primary Outcome Measure Information:
Title
Bone Mineral Density
Description
DEXA(Dual-energy X-ray absorptiometry)
Time Frame
Six months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hend Reda, PhD
Organizational Affiliation
Badr University in Cairo
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Therapy, Badr University
City
Cairo
ZIP/Postal Code
11829
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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