Intermittent Fasting, Weight Loss, Behavioral Economic, Obese, HOMA-IR
Conditions
Keywords
Intermittent Fasting, behavioral economic, Obese patients, Weight control, HOMA-IR
Brief summary
This study is a parallel randomized controlled trial (RCT). To determine the effect of intermittent fasting, intermittent fasting with behavioral economics, and intensive lifestyle modification on nutritional status; the differences between HOMA-IR, body weight change, and body composition in obese people. Each participant will be randomized to receive the intervention (intermittent fasting, intermittent fasting with behavioral economics, or intensive lifestyle modification. The study protocol will be explained to the eligible participant and informed written consent will be obtained. The total sample size will be 123 participants. Blood and urine samples will be collected at baseline and each follow-up visit including 1-month, 2-months, 6-month, and 12-months, respectively for further study to find out the mechanisms of weight loss, weight regain, and the improvement in the metabolic disease.
Detailed description
The investigators will collect the participant characteristics (age, gender, smoking history, comorbid diseases including history of previous stroke, myocardial infarction, angina, hypertension, dyslipidemia, T2DM, risk of osteoporosis, and all medication lists) at the first visit. * Physiological parameters: 1. Body composition will be assessed by the Bioelectrical Impedance at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months). 2. Peripheral venous blood sample (15mL: clotted blood 9mL and EDTA blood 6 mL) and urinalysis will be collected from all participants at baseline and each follow-up visit (1-month, 2-months, 6-month, and 12 months). Blood samples will be immediately centrifuged and plasma/serum will be placed in a -80 Celsius freezer until analysis (glucose, HbA1C, insulin, albumin, creatinine, uric acid, lipid profile, liver function test, kidney function test, thyroid function test, and other biochemical). * Three questionnaires will be collected: 1\) Global physical activity questionnaire, sleep questionnaire, and satiety visual analog score questionnaire will be obtained at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months). * Nutritional status will be assessed by history, 24-hour dietary recall, 3days food record, and physical examinations at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months). Regarding the descriptive statistical analysis, all the data will be tested for normality. Data will be presented as Mean ± standard deviation or Median (interquartile ranges) for continuous variables and frequency (%) for binary and categorical variables. The continuous variables will be compared by using Independent samples T-test or Analysis of variance (ANOVA) followed by multiple comparisons with the Bonferroni method. Test results of categorical variables will be evaluated by Chi-square or Fisher exact test as appropriate. Results will be deemed statistically significant at a P-value \< 0.05.
Interventions
BEHAVIORALIntermittent fasting
The participant will consume food about/ within 8-hour per day
BEHAVIORALIntermittent fasting + Behavioral economic
The participant will consume food about/ within 8-hour per day. They will be received a reward as money when achieve weight loss goal or/and success doing intermittent fasting 5 days/week
BEHAVIORALIntensive Lifestyle Modification
Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise
Sponsors
Health Systems Research Institute,Thailand
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18-65 year * BMI start at 25.0 kg/m2 (above 24.99 kg/m2) * Weight change less than 5% in 6-month * Ability and willingness to provide informed consent
Exclusion criteria
* Pregnant women or breed feeding * Kidney disease/ Liver disease * Abnormal Thyroid hormone, abnormal GI function * Postoperative bariatric surgery * Drug control weight or reduce appetite * Drug abuse * Mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HOMR-IR (index) | Change from Baseline HOMR-IR at 6 months and 12 months | Homeostatic Model Assessment for Insulin Resistance |
| Body mass index (kg/m^2) | Change from Baseline Body mass index at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months | Body weight and height will be combined to report BMI in kg/m\^2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FBS (mg/dl) | Change from Baseline FBS (mg/dl) at 1 month, 2 months, 6 months, and 12 months | Fasting blood glucose |
| HbA1C (%) | Change from Baseline HbA1C (%) at 1 month, 2 months, 6 months, and 12 months | Average blood sugar levels over the past 3 months |
| Albumin (g/L) | Change from Baseline Albumin (g/L) at 1 month, 2 months, 6 months, and 12 months | a blood plasma protein synthesized in the liver |
| Creatinine (mg/dL) | Change from Baseline Creatinine (mg/dL) at 1 month, 2 months, 6 months, and 12 months | a waste product that comes from the normal wear and tear on muscles of the body |
| Alanine transaminase (ALT) U/L | Change from Baseline Alanine transaminase (ALT) U/L at 1 month, 2 months, 6 months, and 12 months | ALT is commonly measured clinically as part of liver function tests |
| Total cholesterol (mg/dL) | Change from Baseline Total cholesterol (mg/dL) at 1 month, 2 months, 6 months, and 12 months | — |
| Aspartate transaminase (AST) U/L | Change from Baseline Aspartate transaminase (AST) U/L at 1 month, 2 months, 6 months, and 12 months | AST is commonly measured clinically as part of liver function tests |
| LDL-C (mg/dL) | Change from Baseline LDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months | Low-density lipoprotein cholesterol |
| Triglycerides (mg/dL) | Change from Baseline Triglycerides (mg/dL) at 1 month, 2 months, 6 months, and 12 months | — |
| Blood Urea Nitrogen (BUN) (mg/dL) | Change from Baseline Blood Urea Nitrogen (BUN) (mg/dL) at 1 month, 2 months, 6 months, and 12 months | — |
| Urine albumin-creatinine ratio (UACR) (mg/g) | Change from Baseline Urine albumin-creatinine ratio (UACR) (mg/g) at 1 month, 2 months, 6 months, and 12 months | — |
| Energy from food (kilocalories) | Change from Baseline Energy from food (kilocalories) at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months | Energy from food (kilocalories) assess by 24hour-dietary recall and 3days food record |
| HDL-C (mg/dL) | Change from Baseline HDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months | High-density lipoprotein cholesterol |
| Uric acid (mg/dL) | Change from Baseline Uric acid (mg/dL) at 1 month, 2 months, 6 months, and 12 months | — |
Countries
Thailand
Outcome results
None listed