Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD

Effect of Acupuncture and Diet Modification on Amenorrhea in Female Athlete Triad

The present study will be designed to investigate the effect of acupuncture and diet modification using soy products on amenorrhea in female athlete triad.

For this purpose this study will be carried out on sixty female athletes participating gymnastics. They will be recruited from Sports Medicine specialized center in Nasr City, their ages will range from 17 to 25 years old and their BMI will be < 20 Kg/m2 .

Study Overview

• Status: Withdrawn
• Conditions: Female Athlete Triad
• Intervention / Treatment: Other: Acupuncture; Dietary supplement: Diet supplementary

Detailed Description

The subjects will be divided into three groups equal in number, matched for measured variable:

Group (A): Acupuncture only will be used in this group for 30 minutes, three times per week for twelve weeks. The acupuncture needles were inserted in points located on the abdomen.

Group (B): This group will receive only the diet modification contains soy products (phytoestrogen) as 100 milliliter soy milk and 100 grams soy beans daily in the morning as a breakfast alone to ensure its absorption, this dose had been taken for 12 weeks.

Group (C): This group will receive both acupuncture therapy for 30 minutes, three times per week for 12 weeks and diet modification contains soy products as 100 milliliter soy milk and 100 grams soy beans daily in the morning for 12 weeks.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Nasr City
    • Cairo, Nasr City, Egypt, 46374
      • Sports medicine speciaized center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All patients suffering from athletic amenorrhea.
• Their age will be ranged from 17-25 years old.
• Their body mass index will be less than 18.5 kg/m2.
• No history of previous pregnancies.
• No history of any pathological disease causing amenorrhea.
• They are medically stable and consented to participate in the study.

Exclusion Criteria:

• Patients with gynecological diseases that may cause amenorrhea.
• Patients using contraceptive pills.
• Patients using hormonal treatment.
• Patients using induction of ovulation methods.
• Patients following any other diet modification method.
• Patients who receive any drug with side effect of amenorrhea.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; this group will receive Acupuncture therapy for 30 minutes three times per week	Other: Acupuncture; this group will receive Acupuncture for 30 minutes three times per week
Experimental: diet modification; this group will receive diet using soy products a	Dietary supplement: Diet supplementary; Diet supplementary with soy product
Experimental: combined group; will receive both acupuncture therapy and soy products	Other: Acupuncture; this group will receive Acupuncture for 30 minutes three times per week; Dietary supplement: Diet supplementary; Diet supplementary with soy product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
follicle stimulating hormone	Blood sample will be taken from the patient at the beginning of the study and three months later to determine the change of hormone level using Immulite 1000 immunoassay analyzer	three months
Luteinizing hormone	Blood sample will be taken from the patient at the beginning of the study and three months later to determine the change of hormone level using Immulite 1000 immunoassay analyzer	three months
estradiol 2	Blood sample will be taken from the patient at the beginning of the study and three months later to determine the change of hormone level using Immulite 1000 immunoassay analyzer	three months

Collaborators and Investigators

• Sponsor: National Research Centre, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2018
• Primary Completion (Anticipated): March 5, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: January 20, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: acupuncture; sports injury; female athlete triad
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Relative Energy Deficiency in Sport; Female Athlete Triad Syndrome
• Other Study ID Numbers: 123 (Giresun University Scientific Research Project)

Drug and device information, study documents

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