CTRI

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CTRI Number

CTRI/2025/07/091075 [Registered on: 17/07/2025] Trial Registered Prospectively

Last Modified On:

11/07/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Preventive
Behavioral

Study Design

Randomized, Parallel Group Trial

Public Title of Study

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

Scientific Title of Study

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

Trial Acronym

MOOP Study

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr. V. Sureka Varalakshmi
Designation	Registrar
Affiliation	Meenakshi Academy Of Higher Education and Research
Address	Meenakshi Academy Of Higher Education and Research Administration Block, No.12, Vembuliamman Koil Street, West KK Nagar, Chennai TAMIL NADU 600078 India
Phone	9895099463
Fax
Email	surekaramesh.v@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. V. Sureka Varalakshmi
Designation	Registrar
Affiliation	Meenakshi Academy Of Higher Education and Research
Address	Meenakshi Academy Of Higher Education and Research No.12, Vembuliamman Koil Street, West KK Nagar, Chennai Chennai TAMIL NADU 600078 India
Phone	9895099463
Fax
Email	surekaramesh.v@gmail.com

Details of Contact Person
Public Query

Name	B Nisha Devi
Designation	PhD Scholar
Affiliation	Meenakshi Academy Of Higher Education and Research
Address	Meenakshi Academy Of Higher Education and Research, Department of Nutrition and Dietetics Faculty of Humanities and Science, No.12, Vembuliamman Koil Street, West KK Nagar, Chennai Chennai TAMIL NADU 600078 India
Phone	9840835799
Fax
Email	b.nishadevi@gmail.com

Source of Monetary or Material Support

Meenakshi Academy of Higher Education and Research, No.12. Vembuliamman Koil Street, West KK Nagar, Chennai - 600078

Primary Sponsor

Name	B. Nisha Devi
Address	Department of Nutrition and Dietetics, Meenakshi Academy of Higher Education and Research, No.12. Vembuliamman Koil Street, West KK Nagar, Chennai - 600078
Type of Sponsor	Other [Self funded]

Details of Secondary Sponsor

Name	Address
NIL	Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
B Nisha Devi	Meenakshi Academy of Higher Education and Research	Department of Nutrition and Dietetics, Faculty of Humanities and Science, No.12, Vembuliamman Koil Street, West KK Nagar, Chennai TAMIL NADU	9840835799 b.nishadevi@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
MAHER Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Adults aged 18 - 50 years
Patients	(1) ICD-10 Condition: E660\|\|Obesity due to excess calories,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Mindful Optimal Oral Processing Training	Mindful Optimal Oral Processing Training with diet and exercise prescription for 12 weeks
Comparator Agent	No training	Diet and Exercise prescription without Mindful Optimal Oral Processing Training for 12 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	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

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Other

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
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	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 Outcome

Outcome

TimePoints

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

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.

Target Sample Size

Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

01/08/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The present study will focus primarily on the chewing level of adults. The aim of the study is to highlight the importance of chewing and study the impact of thorough chewing with complete oral processing on weight loss, lipid profile and gut health. First, we will provide various foods from the Five Food Groups (ICMR), 3 foods from each group and measure how much adults normally chew the food, then see how many chews are needed to completely and thoroughly process the food in the mouth, ensuring that the food is not swallowed while chewing and adequate saliva is secreted to mix with food and create a fine paste of bolus. Once the average number of chews needed for each type of food group and texture is determined, we will create a Mindful Optimal Oral Processing Training Protocol. This protocol will be the intervention for adult women aged 30 - 45 years. It will be a double-blinded, parallel arm study. The participants will be divided into 2 groups - the intervention group that receives the protocol along with a diet and exercise prescription for weight loss and improvement in gut health. The control group will receive only the diet and exercise prescription. They will not be prompted to focus on their chewing. Daily online sessions will be conducted to monitor their food intake and the participants will be encouraged to update their daily food intake, exercises done and bowel movements in journals. Various parameters like weight, BMI, girth measurements like waist, abdomen, hip, neck; lipid profile, gut health, stress, anxiety, sleep quality, zonulin, salivary pH, salivary flow rate, gut hormones will be measured at baseline and after 12 weeks of intervention. We hypothesised that the MOOP intervention group will have more weight loss and improved gut health compared to the control group. This study will have a significant impact on understanding the importance of eating behaviour and in what way the way a person eats can transform their health.