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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06261229
Other study ID # MURA2022/230
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 18, 2022
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 123
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intermittent fasting
The participant will consume food about/ within 8-hour per day
Intermittent 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
Intensive Lifestyle Modification
Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise

Locations

Country Name City State
Thailand Mahidol University Ratchathewi Bangkok

Sponsors (2)

Lead Sponsor Collaborator
Mahidol University Health Systems Research Institute

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary HOMR-IR (index) Homeostatic Model Assessment for Insulin Resistance Change from Baseline HOMR-IR at 6 months and 12 months
Primary Body mass index (kg/m^2) Body weight and height will be combined to report BMI in kg/m^2 Change from Baseline Body mass index at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months
Secondary FBS (mg/dl) Fasting blood glucose Change from Baseline FBS (mg/dl) at 1 month, 2 months, 6 months, and 12 months
Secondary HbA1C (%) Average blood sugar levels over the past 3 months Change from Baseline HbA1C (%) at 1 month, 2 months, 6 months, and 12 months
Secondary Albumin (g/L) a blood plasma protein synthesized in the liver Change from Baseline Albumin (g/L) at 1 month, 2 months, 6 months, and 12 months
Secondary Creatinine (mg/dL) a waste product that comes from the normal wear and tear on muscles of the body Change from Baseline Creatinine (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Secondary Alanine transaminase (ALT) U/L ALT is commonly measured clinically as part of liver function tests Change from Baseline Alanine transaminase (ALT) U/L at 1 month, 2 months, 6 months, and 12 months
Secondary Aspartate transaminase (AST) U/L AST is commonly measured clinically as part of liver function tests Change from Baseline Aspartate transaminase (AST) U/L at 1 month, 2 months, 6 months, and 12 months
Secondary Uric acid (mg/dL) Change from Baseline Uric acid (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Secondary Total cholesterol (mg/dL) Change from Baseline Total cholesterol (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Secondary HDL-C (mg/dL) High-density lipoprotein cholesterol Change from Baseline HDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Secondary LDL-C (mg/dL) Low-density lipoprotein cholesterol Change from Baseline LDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Secondary Triglycerides (mg/dL) Change from Baseline Triglycerides (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Secondary 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
Secondary 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
Secondary Energy from food (kilocalories) Energy from food (kilocalories) assess by 24hour-dietary recall and 3days food record Change from Baseline Energy from food (kilocalories) at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months
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