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

Sponsor

Hend Reda Sakr (Other)

Overall Status

Completed

CT.gov ID

NCT04748250

Collaborator

(none)

Enrollment

Location

Arms

7.1

Actual Duration (Months)

8.5

Patients Per Site Per Month

Study Details

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	N/A

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

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 :

Jul 20, 2020

Actual Primary Completion Date :

Feb 10, 2021

Actual Study Completion Date :

Feb 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.

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

Bone Mineral Density [Six months]
DEXA(Dual-energy X-ray absorptiometry)

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 18 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Feb 10, 2021

Last Update Posted:

Nov 10, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hend Reda Sakr, Principal investigator and Lecturer at Department of Physical Therapy for Woman's Health, Badr University

female athlete triad

Additional relevant MeSH terms:

Osteoporosis

Bone Diseases, Metabolic

Female Athlete Triad Syndrome

Phytoestrogens

Study Results

No Results Posted as of Nov 10, 2021