Relationship between lifestyle and body mass index in young women: monitoring study

UMIN ID: UMIN000049875

Registered date:22/12/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Young women (BMI; underweight, standard)
• Date of first enrollment: 2022/12/23
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Standard body type: Monitoring measurements during 4 menstrual cycles (daily: heart rate, activity, weight, basal body temperature, and daily life record; follicular and luteal phases: body composition, dietary record; luteal phase only: blood sampling, sleep and menstrual questionnaire; 4 times: urine collection) One measurement during each of the four cycles (75 g oral glucose tolerance test, estimation of energy expenditure by double-labeled water method, physical fitness test, DXA measurement) Once in each of the 4 cycles: follicular phase and luteal phase (sleep rhythm, simple electroencephalograph, continuous blood glucose measurement, continuous body temperature measurement)
Underweight body type: Monitoring measurements during 4 menstrual cycles (daily: heart rate, activity, weight, basal body temperature, and daily life record; follicular and luteal phases: body composition, dietary record; luteal phase only: blood sampling, sleep and menstrual questionnaire; 4 times: urine collection) One measurement during each of the four cycles (75 g oral glucose tolerance test, estimation of energy expenditure by double-labeled water method, physical fitness test, DXA measurement) Once in each of the 4 cycles: follicular phase and luteal phase (sleep rhythm, simple electroencephalograph, continuous blood glucose measurement, continuous body temperature measurement)

Outcome(s)

• Primary Outcome: Heart rate variability associated with the menstrual cycle (including assessment of autonomic nervous system activity)
• Secondary Outcome: Urinary metabolites associated with the menstrual cycle (urine metabolome analysis), assessment of energy intake and nutrients (nutrient value calculation), sleep quality (simple EEG measurement and subjective questionnaire)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 25years-old
• Gender: Female
• Exclude criteria: People who cannot comply with the conditions, people who have been diagnosed with or are currently undergoing treatment for an eating disorder, people who have been (or are) taking/using hormone preparations (e.g., pills) for the past six months, people with irregular menstruation (amenorrhea is OK), people who exercise more than five days a week, people diagnosed with lifestyle-related diseases (diabetes, hypertension, etc.), pregnant or nursing mothers, smokers

Related Information

• Primary Sponsor: Hiroshima University
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare