Effect of Time restricted feeding on body weight, body composition and biochemical parameters in obese adults

Not Applicable

• Conditions: Health Condition 1: E660- Obesity due to excess calories

• Registration Number: CTRI/2022/06/043312
• Lead Sponsor: ALL INDIA INSTITUTE OF MEDICAL SCIENCES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Age 18-60 years

Body Mass Index between 25-40 kg/m2

Willing to participate and assuring cooperation in the study

Exclusion Criteria

Known case or recently diagnosed diabetes mellitus

Participants undergone any recent surgery

Acute infection and advanced end organ damage

History of pancreatitis

Chronic liver disease, chronic heart disease and chronic kidney disease

Pregnancy and lactation at the time of study

Presence of zero positivity for Hepatitis B, Hepatitis C and Human Immunodeficiency Virus (HIV)

Excessive smoking and alcohol use ( <20 g a day for women and <30 g for men)

Currently enrolled or been a part of any weight loss program in last three months

Intake of any anti-obesity drugs like orlistat, liraglutide, etc. currently or in the last three months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight, Height, Circumferences and skinfolds <br/ ><br>Serum insulin, C-Reactive protein, ghrelin, cortisol, resistin, visfatin, asprosin, pentraxin-3, leptin, irisin, adiponectin, paraoxonase-1 (PON-1), cytokines, melatonin, circulating adipsin. <br/ ><br>Fasting blood glucose, Lipid profile, Complete Blood Count, Liver Function Test, Kidney Function Test, Oral Glucose Tolerance Test, Vitamin D, <br/ ><br>BIA and DEXA Scan <br/ ><br>Timepoint: At baseline, 6 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Dietary AssessmentTwo-day dietary recall (one weekday and one weekend) along with validated Semi Quantitative Food Frequency Questionnaire. <br/ ><br>Energy ExpenditureGlobal Physical Activity Questionnaire <br/ ><br>Indirect CalorimetryMetabolic Cart Technique <br/ ><br>Muscle strengthHydraulic Hand Grip Dynamometer <br/ ><br>Nutritional ChronotypeChrononutrition Profile – Questionnaire (CP-Q) <br/ ><br>Sleep QualityPittsburgh Sleep Quality Index (PQSI) <br/ ><br>Quality of LifeShort Form-36 questionnaire <br/ ><br>Timepoint: BASELINE, 1.5 MONTHS AND FINAL FOLLOW-UP