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CTRI Number  CTRI/2021/04/032994 [Registered on: 22/04/2021] Trial Registered Prospectively
Last Modified On: 25/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of dietary supplement on the performance of athletes  
Scientific Title of Study   A study on principles of Ahara and its application in sports medicine 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Preetpal Singh 
Designation  Ph.D. Scholar 
Affiliation  I.T.R.A. Jamnagar 
Address  ITRA, Dept. of Basic Principles, OPD No.11, Opposite city B division police-station, PN marg, Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  8053409656  
Fax    
Email  singhpreet523@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof H A Vyas 
Designation  Professor (Dept. of Basic Principles) 
Affiliation  I.T.R.A. Jamnagar 
Address  ITRA, Dept. of Basic Principles, OPD No.11, Opposite city B division police-station, PN marg, Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9426433231  
Fax    
Email  drhavyas@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Prof H A Vyas 
Designation  Professor (Dept. of Basic Principles) 
Affiliation  I.T.R.A. Jamnagar 
Address  ITRA, Dept. of Basic Principles, OPD No.11, Opposite city B division police-station, PN marg, Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9426433231  
Fax    
Email  drhavyas@yahoo.co.in  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Jamnagar 361008 
 
Primary Sponsor  
Name  Institute of teaching and research in Ayurveda Jamnagar  
Address  ITRA, Opposite city B division police-station, PN marg, Jamnagar GUJARAT 361008 India 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Preetpal Singh  I.T.R.A. Jamnagar  OPD no.11,Dept. of Basic Principles, I.T.R.A. Jamnagar
Jamnagar
GUJARAT 
8053409656

singhpreet523@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Institute of Teaching and Research in Ayurveda, Jamnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy active athletes of age 18 years to 35 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Yava-Sattu-Mantha  Peeled Yava will be roasted and transformed into powder form. Powder than will be mixed with appropriate quantity of Ghee. Dose: 20gms powder (morning and evening empty stomach) Method of consumption: Powder should be mixed with water (Q.S. to make semisolid mixture) and to be swallowed without chewing. Duration: 15 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1.Healthy active athletes between the age group of 18 years to 35 years.
2.Only trained athletes, who have played/playing minimum university or district level sports competitions will be included in the study.
3.Athletes not visited hospital in the last 3 months for any illness.
4.Athletes not taking medications for any chronic illness.
5.Athletes not taking any other performance enhancing drug simultaneously.
 
 
ExclusionCriteria 
Details  1.Age of athletes less than 18 years and more than 35 years.
2.Athletes having any chronic or acute illness.
3.Athletes suffering from sport injury or orthopedic injury.
4.Athletes taking any medication or steroids to enhance physical performance.
5.Athletes having history of drug abuse.
6.Athletes having history of weight loss >5 kg in previous 3 months.
7.Athletes having BMI >25kg/m2 i.e. overweight
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
it is expected that principles or Ahara described in Ayurvedic classical texts plays vital role in improving recovery time and performance
of athletes.  
15 days 
 
Secondary Outcome  
Outcome  TimePoints 
it is expected that intervention of yava sattu in the form of mantha is effective in speedy recovery of athletes from fatigue  15 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/06/2021 
Date of Study Completion (India) 24/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Standardization and Sensory evaluation of Sattu-Mantha: A traditional energy drink 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Introduction: Ayurveda gives similar importance to both Ahara (diet) and Aushadha  (medicine). Ayurvedic dietetics specified the qualities of food according to person’s need. It includes various food preparations and drinks. Selection of food according to the personal need is also the focus point of modern dietetics. Now a day’s many sub branches of dietetics have been developed like clinical dietetics, community dietetics, neonatal dietetics, gerontological dietetics etc. One of such emerging branches is sports dietetics which deals with specific food according to the need of sports persons.

Aim and objectives: This study was planned with the aim, to apply the Ayurvedic principles of Ahara in sports diet science. Objectives of the study were to explore principles of Ahara described in Ayurveda classics in context of sports science and to explain and understand contemporary dietetics especially sport dietetics. Other objectives of the study were, to plan the diet for athletes considering their physiological requirements and to evaluate effect of Sattu Mantha for recovery of muscles in healthy athletes.

Material and methods: For conceptual study principles related to Ahara described in classical texts of Ayurveda and principles of sports dietetics were compiled and analyzed how principles of Ahara can be applied in sports dietetics. Material related to Saktu mentioned in Samhita and Nighantu was compiled and analyzed. Yava Saktu was prepared as mentioned in classical texts of Ayurveda i.e. Yava (barley) seeds were roasted in heated sand with continuous stirring, then roasted seeds were milled and sieved through mess no. 72. Then Pharmaceutical evaluation of Saktu and sensory evaluation of Saktu-Mantha for two types of samples i.e. one prepared by mixing with jaggery and other with Sugar powder, were carried out and Saktu-Mantha prepared with sugar powder was selected for the interventional study. Total 50 healthy and active athletes were enrolled in the study. Detailed history of the athletes was taken on specially prepared research proforma. Then vitals of the athletes were recorded and blood samples were taken. After that physical tests were performed and then again blood sample and vitals of the athletes were taken immediate after exercise, 5 minutes, 10 minutes, 15 minutes and 20 minutes after exercise. Then athletes were advised to consume Yava Saktu in the form of Mantha, two times in a day for 15 days. After 15 days, again before and after physical tests, blood samples and vitals of the athletes were recorded.

Results: After completion of interventional study, on comparing before and after intervention results of physical tests i.e. horizontal jump, rope jumping, push-ups, sit-ups abdominal, 800 meter run and repeated sprint ability test it was observed that there is statistically highly significant improvement after intervention. In case of vitals i.e. Blood pressure, pulse rate, respiration rate, after intervention vitals come to normal state rapidly as compare to before intervention. In case of hematological parameters before intervention and after intervention results are statistically highly significant for neutrophils and monocytes and significant for Hb%, total R.B.C., lymphocytes and P.C.V. and insignificant for rest of the hematological parameters. In case of biochemical parameters before intervention and after intervention results are statistically significant for CPK-MM and insignificant for rest of the parameters. Overall effect of intervention on recovery of athletes: 96% athletes are moderately recovered and 4% athletes recovered slightly after intervention as compared to before intervention.

Discussion: Classical texts of Ayurveda explain in detail about principles for selecting Ahara as per individual’s body constitution, Agni, season, habitat and also diseased condition. Ayurveda give more important to digestion and absorption of Ahara while modern dietetics concentrate more on nutritional values and calories present in food. As per principles mentioned in classical texts of Ayurveda we can select food according to need of the athletes, which provide them proper nutrition, also digest easily and will help in maintaining healthy state of the body which also helps in improving their sports performance. In applied study, as per shown in the results horizontal jump length, timing of rope jumping, number of push-ups, number of sit-ups (abdominal) and repeated sprint ability test (RSA) were improved after intervention and timing of 800m run and score of the perceived exertion scale were decreased, it shows that Sattu-Mantha provides strength to the body so due to that performance of athletes also improved. Vitals measurement also shows that blood pressure, respiration rate and pulse rate of athletes normalizes rapidly after intervention as compared to before intervention, it shows Sadya Balakara and Sadya Shramahara properties of Sattu-Mantha.

Conclusion: By applying principles of dietetics mentioned in Ayurveda i.e slection of food according to Prakriti, Ritu, Agni, Desha, Kala, Samskara and Samyoga we can enrich more to sports dietetics. This ultimately helps in improving performance of sports persons. Yava Saktu in the form of Mantha is helpful in enhancing performance of athletes and also helpful in fast recovery of athletes from fatigue.


 
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