Health Condition 1: E660- Obesity due to excess calories
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Phase 1 Age 18 to 25 Healthy BMI from 18.5 to 23 kg per m2 Complete dentition with or without 3rd molars Ready to volunteer and provide written consent Phase 2 Adults aged 18 to 50 years Ability to chew and swallow normally healthy complete dentition, except 3rd molars normal occlusion BMI 18.5 to 30 Willingness to participate and provide informed consent Phase 3 Married women aged 30 to 45 years living in Chennai Housewives, not working, for ease of monitoring chewing Able to perform their daily living activities independently BMI greater than or equal to 25 kg per m2 as per WHO Expert Consultation Report on BMI in Asian Populations, 2004 Ability to chew and swallow normally healthy complete dentition, except 3rd molars normal occlusion Willingness to participate and provide informed consent
Exclusion criteria
Exclusion criteria: Phase 1 Below 18 years Current or recent dental orthodontic treatment Masticatory disorders Having difficulty in tasting and smelling Not in general good health Has hearing impairment Phase 2 Dental, masticatory, swallowing disorders Phase 3 Current or recent dental or orthodontic treatment Masticatory disorders Physical deformities causing immobility Diagnosed with diabetes or other chronic diseases Use of medications affecting glycemic control Pregnancy or lactation Cognitive or physical impairments affecting participation Hospitalized in the past 6 months Physical injury or surgery in the past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weight, in kg Change in girth measurements, in cm Gut permeability, with zonulin levels Increase in Chew count and duration Reduction in salivary pH Increased Salivary flow rate Improved brainwaves using EEG Timepoint: All measurements except EEG will be taken at baseline and after 12 weeks. EEG will be taken before and after a short chewing session. | — |
Secondary
| Measure | Time frame |
|---|---|
| Average number of chews Chewing duration per bite of food sample Increase in chew count Particle Size distribution of bolus dual sugar assay Improved gut transit time Improved interoception Sleep quality using pittsburg sleep index Perceived speed of eating and perceived stress on a 10 point VAS scale Quality of life using The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Mindful Eating using Mindful Eating Questionnaire Timepoint: Fasting blood glucose and lipid profile along with perceived stress, sleep quality, mindful eating, quality of life will be assessed at baseline and after 12 weeks Chew count, chewing duration, particle size of bolus will be measured at baseline, at 12 weeks. | — |
Countries
India
Contacts
Meenakshi Academy Of Higher Education and Research