None listed
Conditions
Interventions
Behavioral : This is an 8-week randomized controlled intervention trial involving 96 sedentary obese men with night eating syndrome (aged 19-39 years, BMI 25 kg/m² or higher). Participants are randoml
Sponsors
Korea University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Adult men aged 19 to 39 years 2) Individuals with obesity, defined as a body mass index (BMI) of 25 kg/m² or higher 3) Sedentary individuals classified as level 1 (inactive) based on the short-form International Physical Activity Questionnaire (IPAQ) 4) Individuals diagnosed with at least mild night eating syndrome (N) according to the Night Eating Diagnostic Questionnaire (NEDQ) 5) Individuals with no weight change exceeding 4 kg over the past 4 months 6) Individuals who fully understand the purpose and procedures of the study and voluntarily provide written informed consent to participate.
Exclusion criteria
Exclusion criteria: 1) Individuals who have attempted or achieved weight loss within the past 4 months 2) Individuals who have taken weight-loss medication 3) Individuals with a rapid increase in body weight 4) Individuals with walking impairment 5) Individuals who have undergone orthopedic surgery 6) Individuals with gastrointestinal disorders 7) Individuals who have undergone cardiovascular-related surgery 8) Patients with type 1 diabetes mellitus 9) Patients with type 2 diabetes mellitus 10) Individuals receiving insulin therapy 11) Individuals with color blindness or color weakness 12) Individuals who have participated in regular exercise within the past 4 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic variability (continuous glucose monitoring);Salivary Cortisol;Cognitive performance(Stroop task, N-back task);Insulin resistance index (HOMA-IR) calculated from fasting glucose and fasting insulin | — |
Secondary
| Measure | Time frame |
|---|---|
| Dietary intake patterns assessed by dietary records;Physical activity assessed by an activity monitor;Body composition assessment;Metabolic blood markers assessed by blood tests;Core body temperature circadian rhythm derived from data collected via an ingestible core body temperature capsule;Glucose response to a 75 g oral glucose tolerance test (glucose at 0/60/120 min);Glycated hemoglobin (HbA1c);Arterial stiffness measured by pulse wave velocity (PWV);Difference in respiratory exchange ratio (RER) between fasting and postprandial states measured by respiratory gas analysis;Inflammatory and anti-inflammatory cytokines (IL-6, IL-10, TNF-a, CRP) and intestinal barrier/endotoxin-related markers (I-FABP, zonulin, LPS, LBP);Fasting and postprandial serum acylcarnitine concentrations;Peak oxygen uptake (VO2peak) and maximal heart rate measured by a graded exercise test;Pittsburgh Sleep Quality Index (PSQI);Nighttime systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse rate measured with an automatic wrist blood pressure monitor;Morningness-Eveningness Questionnaire (MEQ), Munich Chronotype Questionnaire (MCTQ), and appetite Visual Analogue Scale (VAS);Self-efficacy scale, resilience scale (KRQ-53), and health-related quality of life scale (SF-36);Gastrointestinal Symptom Rating Scale (GSRS), Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of Life (PAC-QOL), and Self-evaluation Questionnaire for Functional Dyspepsia (SEQ-DYSPEPSIA);Two-dimensional mood scale (vitality and stability) before and after cognitive function testing | — |
Countries
Korea, Republic of
Contacts
Public ContactJungmin Lee
Korea University
Outcome results
None listed