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

B. Nisha Devi1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2025年8月1日最近更新: 2025年7月11日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 200
试验地点: 1
主要终点: Change in weight, in kg

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 50.00 Year(s)（—）
性别: All

入选标准

•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.

排除标准

•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.