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CTRI Number  CTRI/2024/07/071232 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 24/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Exploratory sequential 
Study Design  Other 
Public Title of Study   Examination of water intake patterns and the impact of drinking water before meals in overweight undergraduate students. 
Scientific Title of Study   Exploration of water consumption habits and effect of pre-meal water consumption among overweight undergraduate students 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sudeep S 
Designation  Student  
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital  
Address  Department of Kriya Shareera Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Mysore Road, Bengaluru 560074

Bangalore
KARNATAKA
560074
India 
Phone  8296980352  
Fax    
Email  sudeep9900nbs2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Resmy Raj A 
Designation  Asst Professor 
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital  
Address  Department of Kriya Shareera Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Mysore Road, Bengaluru 560074

Bangalore
KARNATAKA
560074
India 
Phone  9995011751  
Fax    
Email  resmyrajphd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sudeep S 
Designation  Student  
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital  
Address  Department of Kriya Shareera Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Mysore Road, Bengaluru 560074

Bangalore
KARNATAKA
560074
India 
Phone  8296980352  
Fax    
Email  sudeep9900nbs2@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi University of Health Sciences, 4th T Block, Jayanagar, Bengaluru - 560041 Karnataka,India. 
 
Primary Sponsor  
Name  Short-term Research Grants for Undergraduate Students 2024-25 
Address  Rajiv Gandhi University of Health Sciences, 4th T Block, Jayanagar, Bengaluru - 560041, Karnataka, India 
Type of Sponsor  Government funding agency 
 
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 
Sudeep S  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital  Department of Kriya Shareera Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Mysore Road, Bengaluru 560074
Bangalore
KARNATAKA 		 8296980352

sudeep9900nbs2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subjects who are free from any acute or chronic illness 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  Volunteers include both genders in the age group of 18-24years.

Volunteers who belong to undergraduate level of education.

Volunteers not using medication known to affect food /water intake or appetite, not athletes in training, not pregnant or lactating, non-smokers.

Volunteers not dieting to gain or lose weight and regularly eating three meals per day. 
 
ExclusionCriteria 
Details  Volunteers who are on some sedatives, hypnotics, and tranquilizers or any other medication for any acute or chronic physical or mental illness.

Volunteers reported a history of depression, eating disorders, current use of medications known to alter food intake or body weight. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Water consumption habits and their relationship with body composition indicators.  3 months for complete study

People who are obese and consuming water after food is considered and advised to consume water before food. Recruited one are assessed with body composition indicators before food and after food. 
 
Secondary Outcome  
Outcome  TimePoints 
Relationship between water consumption habits and agni
Effect of pre consumption of water on reducing overweight 		 8 weeks 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   10/08/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Excell sheet

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Background of study
“Obesity is defined as abnormal or excessive fat accumulation that may impair health”. Substances that interact with the SNS can act as agents for weight loss (It is also possible through water). According to Ayurveda, Proper usage of water balances all 3 doshas (entities), maintains the normal functions of all dhatus(tissues). As per the compendium, “Water taken before meals causes agnisada and krsatva on the contrary water taken at the end of meals causes accumulation of kapha above amashaya (stomach). Water taken in between the meals causes equilibrium of dhatu, and facilitates proper digestion and also gives comfort”. Taking this as a reference, this study explores the habit of water consumption, its effect on status of agni, and role of consumption pattern on body composition. 

Purpose of study
In the fast moving society consumption of high energy food is increasing and physical activity is decreasing which is leading to obesity. Prediction have been made that the prevalence of overweight is more than obesity. This fast prevalence of overweight can further lead to obesity. Obesity is associated with diabetes mellitus, coronary heart disease, cancer, sleepbreathing disorders, etc. which are chronic disorders eventually they are fatal. Extensive literature reviews on patterns of water consumption during meals proves its effect on maintaining a healthy weight and it proves to be top in hierarchy because of its low cost and no side effects and hence, this study aims to explore the habits of water consumption in undergraduates, assessing the correlation between status of agni with pattern of water consumption.

The present study “Exploration of water consumption habits and effect of pre-meal water consumption among overweight undergraduate students” is planned as a mixed method (Exploratory sequential design) study. 

Aim of the study is to find out the habits of water consumption among undergraduate students and also to understand the effect of pre-meal water consumption among overweight students. 

Research Question 
How much variation exists in the habits of water consumption during meal among undergraduate students and whether adapting to pre-meal water consumption has any effect on body composition evident within 8 weeks. 

Hypothesis
Empirical hypothesis 
There is relation of water consumption patterns and body composition indicators. Pre meal consumption of water has effect in reducing overweight. 

Study design
Exploratory sequential design (Mixed method design) 

Study setting 
SDM Institute of Ayurveda and Hospital, Bengaluru 

Population 
Undergraduate students of any college in India 

Sample 
Undergraduate student of SDM Institute of Ayurveda and Hospital, Bengaluru 

Study Duration 
3 Months 

Sampling method 
Random sampling can be done with random number generated by Excel based on register number. 
 
Sample size 
n= [(Z1-∞/2)2 P (1-P)]/d2, Assuming P=50%, d=10%, the sample size comes around 96. 
Where , 
n = Desired sample size 
Z1-α/2 = Critical value and a standard value for the corresponding level of confidence. (At 95% CI or 5% level of significance (type-I error) it is 1.96) 
P = Expected prevalence
d = Margin of error or precision 

Selection of study participants 

Inclusion criteria
  • Volunteers include both genders in the age group of 18-24years.
  • Volunteers who belong to undergraduate level of education. 
  • Volunteers not using medication known to affect food /water intake or appetite, not athletes in training, not pregnant or lactating, non-smokers. 
  • Volunteers not dieting to gain or lose weight and regularly eating three meals per day. 

Exclusion criteria
  • Volunteers who are on some sedatives, hypnotics, and tranquilizers or any other medication for any acute or chronic physical or mental illness.
  • Volunteers reported a history of depression, eating disorders, current use of medications known to alter food intake or body weight. 

Data collection tools
  • Assessment of Prakriti with Ayusoft Software from C-DAC, Pune.
  • Assessment of Agni with self-assessment tool developed by Aparna Singh et al. 
  • Assessment of body composition by Durnin & Womersley equation. 
  • Assessment of skin folds thickness by Harpenden’s Skin fold calliper developed by Micro Teknik. 
  • Assessment of habits of water consumption by prepared questionnaire. 

Materials for study 

Prakriti assessment with Ayusoft software 

This software has been developed in collaboration with Government of India’s Center of Development for Advanced Computing(C-DAC), Pune; Interdisciplinary School of Health Sciences and Department of Ayurveda, University of Pune; Department of Ayurveda Savitribaiphule University of Pune and JnanaPrabodhini, NGO, Pune, India. The data base includes more than five lakh records consisting of information from nine text books including Bruhatrayeeand Madavanidana. The software (http://ayusoft.cdac.in) converts the classical Ayurveda literature to comprehensive, authentic and interactive knowledge repositories. There are desktop, intranet and internet versions are available for the particular software.IT professionals and Ayurveda experts around the world takes part in development of the software. Particulars regarding the software can be accessed through https://www.cdac.in/index.aspx. PrakritiVichaya module of Ayusoft assesses human constitution with around 83 questions. The questionnaire includes elements like history of disease, ethnicity, maternal and paternal family history of diseases, allergies, physical, psychological, physiological and anatomical examination of participants. Advices regarding dietary habits for different prakriti are also available in the software. Each option of the questionnaire refers to a property of vata, pitta or kapha. Trained clinician can rate the questions and administration time is around 15-20 minutes. The software assesses Prakriti with built-in weightage configuration and traits corresponding to physical or anatomical characteristics were assigned higher weightage as these traits will be stable throughout life whereas those pertaining to physiological and psychological can vary with habitat hence had lesser weightage. Clinician can modulate the weightage within the software and can complete prakriti assessment. It assesses only the relative percentage of each dosha out of total 100% and not its absolute percentage. Resultant output from the Ayusoft classifies an individual as dwandajaprakriti(dual constitution) as the occurrence of ekadoshajaprakriti is very uncommon. Studies considered vata pitta and pitta vata constitution as equivalent and titled as Vata Pitta. Similarly, vata kapha and kapha vata as Vata Kapha. Some other studies considered six dual constitutions like vata pitta, pitta vata, vata kapha, kapha vata,piita kapha and kapha pitta based on percentage of primary dosha ≥50% and secondary dosha as ≥25-35% and sama dosha (equal combination of vata,pitta, kapha) as separate. 
Ayusoft can be purchased from C-DAC, Pune, Department of Information Technology, Ministry of Communications and Information Technology (MCIT), India. The cost of Prakritivichaya module is around Rs.4925 including shipping charge. To install the software, the client computer should have Windows Vista, Windows 7/Windows 8 as the operating system, processor of 1 Giga hertz or faster 32 bit or 64-bit processor, with 2 GB RAM memory, Microsoft word option 2000 above, Excel 2000 and above and IE Version 6.0 and above, Hard disk of 2 GB space for software and 100 MB per patient.

  • Assessment of Agni Bala with self-assessment tool 
 The tool to estimate agnibala is taken from “Self- assessment tool to estimate agnibala” developed by Singh A, Singh G, Patwardhan K, Gehlot S. Statistical test confirmed the reliability and validity of the tool and various studies have used this tool to assess agnibala of population. Questionnaire has attached as annexure 2.

  • Assessment of skin fold thickness by Harpenden’s Skin fold calliper developed by Micro Teknik 
The Skin fold Calliper is a precision instrument designed for use in the performance of Skin fold thickness measurements from which estimates of body fat are derived. The calliper for the present study is developed by Micro Teknik. It is the only Calliper CE marked under the Medical Devices Directive 93/42/EEC for a Class 1 Device with Measuring Function and is calibrated using masters traceable to National Standards. The peculiar features of the instrument include Dial Graduation: 0, 20 mm, Measuring Range: 0 mm to 80 mm, Measuring Pressure: 10gms/mm2 (constant over range), Accuracy: 99.00%, Repeatability: 0, 20 mm. The instrument is used to measure skin fold thickness of biceps, triceps, sub scapular and supra iliac areas. Details of the instrument and the procedures for measurement are attached as annexure 3.

  • Assessment of body composition by Durnin & Womersley equation
The skin fold equations are used for estimation of percentage of body fat. The fat estimation by skin-fold is by far the simplest and cost-effective method available till now. Skin-fold equations are cheaper, more practical and can be used in routine practice to assess body fat. Durnin and Womersley equations use the skin fold thickness to measure body fat percentage. 

Durnin and Wormsley equations are used to find out the body density. 

 
 Age group (years) Male subjects Female subjects  
 <17 D = 1.1533 - (0.0643 X L) D = 1.1369 - (0.0598 X L) 
 17 - 19  D = 1.1620 - (0.0630 X L)  D = 1.1549 - (0.0678 X L) 
 20 - 29
 D = 1.1631 - (0.0632 X L) D = 1.1599 - (0.0717 X L)
 30 - 39 D = 1.1422 - (0.0544 X L)  D = 1.1423 - (0.0632 X L)
 40 - 49 D = 1.1620 - (0.0700 X L) D = 1.1333 - (0.0612 X L) 
 >59 D = 1.1715 - (0.0779 X L) D = 1.1339 - (0.0645 X L) 

Here, D = Density; L = log of sum of skin fold 
The body density obtained is then converted to a body fat percentage amount using the Siri formula: 

% Body Fat = (495 / Body Density) – 450 
After deriving the body fat percentage, the body fat mass can be calculated. Fat free mass can be calculated from the given formula: 

Weight [Kg] x (1-(body fat [%]/100)). 

Assessment of BMI 

During the screening visit, the patient’s height is measured with a wall-mounted stadiometer, with accuracy to within 0.1 cm. Using a digital scale, body weight is calculated to the nearest 0.1 kg when wearing light clothing and without shoes. Participants height and weight can be used to compute BMI 

  • Assessment of habits of water consumption by prepared questionnaire. 
Questionnaire regarding the - time of consumption of water, total amount of drinking water per day etc. will be collected with prepared questionnaire to understand the habits of water consumption. Added as annexure 4. 

Study design 

96 undergraduate students who are studying in SDM Institute of Ayurveda will be recruited as per inclusion and exclusion criteria through random sampling method. Volunteers will be explained the study protocol, purpose, duration and procedure of the study. Written informed consent will be taken from all participants after answering the queries of them. Informed consent form is attached as annexure 1. Data regarding demographic characteristics will be collected during screening. Their Prakriti will be analyzed through PrakritiVichaya module of Ayusoft, CDAC Pune and agnibala assessment will be done with a self-assessment tool developed by Kishor Patwardhan, Et al. They will be given a questionnaire to explore the habits of daily consumption of water during three regular meals. Their height, weight and skin fold thickness will also be measured to estimate BMI, body composition markers like body fat percentage and fat free mass.

Overweight subjects (23.0–24.9 kg/m2) who consume water after meals will be considered for a nested pilot research, once baseline data has been collected. They will be advised to drink 500 ml water 15-30 minutes prior to breakfast, lunch and dinner for 8 weeks. 500ml cup will be distributed to every participant to ensure the standard consumption of water. Motivational instruction of drinking water will be mailed to each participant on weekly basis. Check in visit or motivational telephone calls of 5-minute duration will be planned with participants once in 2 weeks. Reminder notifications will be sent through Google calendar to each participant 30 minutes before every meal for continuous 8 weeks. Throughout the test, subjects will be instructed to maintain their usual routines for food intake and activity level. After 8 weeks of intervention, participants body fat mass will be calculated using measurements of weight, height, skin fold thickness. Following that, a statistical analysis will be conducted.

Statistical analysis 

The habits of consumption of water among undergraduate study will be represented as descriptive statistics. Weight distribution among subjects will be represented as mean with standard deviation. The relationship between water drinking habit and status of agni will be checked with chi square test. The comparison of body composition indicators before and after the intervention will be compared using Wilcoxon signed-rank test. The relationship of body composition parameters with pre consumption of water will be analyzed through proper statistical tests like Spearman’s correlation coefficient by SPSS software 16 (:233 South Wacker Drive, 11th Floor, Chicago, trademarks of Apple Computer, Inc., registered in the U.S.) 
 
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