臨床研究等提出・公開システム

Date of registration	July. 07, 2022
Last modified on	July. 07, 2022
Trial ID	jRCT1030220189

Scientific Title	Investigation aimed improvement of energy deficiency of female athlete
Public Title	Energy deficiency of female athlete

Contact for Scientific Queries	Name	Toyomi Satoh
	Affiliation	Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba
	Address	1-1-1 Tennoudai, Tsukuba, Ibaraki 305-8575, Japan
	Telephone	+81-298533073
	E-mail	toyomi-s@md.tsukuba.ac.jp
Contact for Public Queries	Name	NAKAO SARI
	Affiliation	Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba
	Address	1-1-1 Tennoudai, Tsukuba, Ibaraki 305-8575, Japan
	Telephone	+81-298533073
	E-mail	s.nakao@md.tsukuba.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		July. 07, 2022
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Female Athlete Eligibility criteria: 1) Energy intake 2000 kcal/d or less or 2) BMI less than 18.5 kg/m2, Weight loss of 5% to 10% in 1 month or Less than 8 menses in 12 months
	Exclusion Criteria	1. Primary amenorrhea 2. Multigravida 3. The gynecological diseases such as myoma, endometriosis, etc., and these need the treatment immediately. 4. Congenital, gastrointestinal, metabolic, feeding and eating disorders, and psychiatric disorders. 5. Lack of understanding of nutritional intervention 6. Lack of understanding of the pathology or the content of this study 7. Decision by the researcher that it is difficult to continue proceeding the protocol
	Age Minimum	18age old over
	Age Maximum	30age old not
	Gender	Female
Health Condition(s) or Problem(s) Studied		Amenorrhea, Osteoporosis
Intervention(s)		Blood test, gynecological interview, grip strength measurement, and athletic performance survey: the timing of star of study and after 6 months and 12 months. Present condition of the nutrition is checked at the start, then the nutritional intervention is done at 1st, 3rd, 6th, 9th, and 12th month of the study. The intervention is provided based on the food and lifestyle records, International Physical Activity Questionnaire (IPAQ), and Food Frequency Questionnaire (FFQ). (The term of the intervention is one year.)
Intervention(s) Keyword		Nutritional and dietary interventions
Primary Outcome(s)		Evaluation of improvement of LEA and FAT after the intervention
Secondary Outcome(s)		Evaluation of the sports performance and grip strength with the improvement of LEA Correlation between EA levels and improvement of menstrual cycle abnormalities and hormone levels

Primary Sponsor	Toyomi Satoh

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Tsukuba Clinical Research and Development Organization
Address	2-1-1, Amakubo, Tsukuba, Ibaraki, Japan, Ibaraki
Telephone	+81-29-853-3914
E-Mail	t-credo.adm@un.tsukuba.ac.jp

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none