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A 12 week clinical trial to study the effect Of Chewing thoroughly on Body Weight, Inch Measurements, Eating Behaviour, Gut Health and stress of obese patients

Mindful Optimal Oral Processing Training on the Anthropometric, Bio-chemical, Eating Behaviour, Gut Health and Psychological Outcomes in Healthy and Obese Adults - A Randomized Controlled Trial - MOOP Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091075
Enrollment
200
Registered
2025-07-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E660- Obesity due to excess calories

Interventions

Intervention1: Mindful Optimal Oral Processing Training: Mindful Optimal Oral Processing Training with diet and exercise prescription for 12 weeks Control Intervention1: No training: Diet and Exercise

Sponsors

B. Nisha Devi
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactB Nisha Devi

Meenakshi Academy Of Higher Education and Research

surekaramesh.v@gmail.com9895099463

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026