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
|
|
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
|
|
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. |