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

NCT04748250 | Completed DMC

• 1 other identifier: Hend1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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?

Conditions

Osteoporosis, Osteopenia

Keywords

female athlete triad

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density

  DEXA(Dual-energy X-ray absorptiometry)

  Six months

Study Arms (3)

Acupuncture Group

EXPERIMENTAL

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

Soy Group

EXPERIMENTAL

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

Acupuncture and Soy Group

EXPERIMENTAL

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; Dietary Supplement: Soy phytoestrogens

Interventions

Acupuncture needles DEVICE

Standard acupuncture needle which is 3 cm long with diameter o.3 mm

Acupuncture Group; Acupuncture and Soy Group

Soy phytoestrogens DIETARY_SUPPLEMENT

100 millilitre of soy milk every day or 100 gram of cooked soy beans per day.

Acupuncture and Soy Group; Soy Group

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Marriage
• Pregnancy
• Taking any hormonal treatment
• Receiving any other form of traditional physical therapy modalities

Sponsors & Collaborators

• Hend Reda Sakr: lead

Study Sites (1)

Faculty of Physical Therapy, Badr University

Cairo, 11829, Egypt

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Female Athlete Triad Syndrome

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Relative Energy Deficiency in Sport; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• Hend Reda, PhD

  Badr University in Cairo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator and Lecturer at Department of Physical Therapy for Woman's Health

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 10, 2021
• Study Start: July 20, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 20, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)