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CTRI Number  CTRI/2023/11/060383 [Registered on: 30/11/2023] Trial Registered Prospectively
Last Modified On: 30/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical
Other (Specify) [Nutritional/food]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   One pomegranate a day increases exercise performance  
Scientific Title of Study
Modification(s)  
Effect of Combined Pomegranate and Beetroot as Whole Fruit and Gummy Formulation on Athletic Performance: A Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swati Khartode 
Designation  Chief Dietitian 
Affiliation  Vishwaraj Hospital 
Address  A-2/38, Ved vihar society, Near Sundar Sankul, Near noble hospital, Magarpatta road Hadapsar Pune - 411013

Pune
MAHARASHTRA
411013
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Khartode 
Designation  Chief Dietitian 
Affiliation  Vishwaraj Hospital 
Address  A-2/38, Ved vihar society, Near Sundar Sankul, Near noble hospital, Magarpatta road Hadapsar Pune - 411013


MAHARASHTRA
411013
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swati Khartode 
Designation  Chief Dietitian 
Affiliation  Vishwaraj Hospital 
Address  A-2/38, Ved vihar society, Near Sundar Sankul, Near noble hospital, Magarpatta road Hadapsar Pune - 411013


MAHARASHTRA
411013
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Source of Monetary or Material Support  
Vishwaraj Hospital 
 
Primary Sponsor  
Name  Vishwaraj Hospital 
Address  Loni Station, Next to hadapsar, Pune solapur Highway pin 412210 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swati Khartode  Vishwaraj Hospital  Vishwaraj Hospital, OPD No.-7, Ground floor, Department of Nutrition and Dietetics, Vishwaraj Hospital Loni station, Next to hadapsar, Pune solapur highway- 412201
Pune
MAHARASHTRA 
9767133699

opd@vrhpune.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee MAEER’s Vishwaraj Hospital Ethics Committee   Approved 
MAEERS Vishwaraj Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Athletes 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Pomegranate fruit  Pomegranate fruit 100 gms Dose- Daily 100 gms pomegranate fruit for 30 days Duration: for 30 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  28.00 Year(s)
Gender  Both 
Details  Doing regular sports activity 5-6 days for 2-3 hrs 
 
ExclusionCriteria 
Details  1. Chronic Kidney disease (CKD)
2. Intestinal mal absorption disorders like colitis, IBS etc 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• To see improvement in athletic performance in athletes by including pomegranate fruit along with normal diet

 
1 month

 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   10/12/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

 

STUDY

RATIONALE

Quercetin is classified as a flavonol, one of the six subclasses of flavonoid compounds and is present in several vegetables, fruits, seeds, nuts, tea and red wine. It is one of the most commonly studied dietary flavonoids as it is an excellent free radical scavenging antioxidant. A diet rich in flavonoids which is known for their antioxidant property reduces the risk for chronic diseases such as diabetes, coronary heart disease and stroke. (Kelly, G. S. (2011) (Boots, A. W., Li, H., Schins, R. P., Duffin, R., Heemskerk, J. W., Bast, A., & Haenen, G. R. (2007). Pomegranate is rich in so many nutrients and polyphenols like quercetin, chlorogenic acid, resvetrol.

Nutritive values of 100 gms pomegranate is as follows,

                

Vital Polyphenols in 100 gms Pomegranate

Chlorogenic Acid

1.6-1.8 mg

Quercetin

2.5 mg

Resevetrol

1.44 mg

Total polyphenols

67-70 mg

 

Pomegranate is an ancient fruit which is worldwide consumed as fresh fruit and juice since ancient times. (Viuda‐Martos, M., Fernández‐López, J., & Pérez‐Álvarez, J. A. (2010).  Pomegranate acts as a therapeutic fruit loaded with different bioactive compounds, it’s different parts like seed, peel, juice and leaves are rich in potential bioactive compounds.( Ranjha, M. M. A. N.,et al. (2021)

Pomegranate is a potent antioxidant. This fruit is rich in flavonoids and has antiatherogenic, antihypertensive, and anti-inflammatory properties. Pomegranate is beneficial in the prevention and treatment of several types of cancer, cardiovascular disease, osteoarthritis, rheumatoid arthritis and to the reproductive system. (Zarfeshany, A., Asgary, S., & Javanmard, S. H. (2014).

Currently, there is not enough data to prove tha t quercetin can be recommended as a sports supplement to increase the physical performance of players in various sports. A large number of studies conducted translate to the lack of unambiguous evidence of a positive and harmless effect so that the substance could be introduced into general use. (Racinowski, M., et al. (2022)

Thus we have seen that many studies conducted to see the effect of quercetin on athletes, cardiac diseases, as an anti-inflammatory and antioxidant agents, but all are in supplement form. As pomegranate is rich in quercetin and also being the local fruit, it is easily available at everywhere throughout the year so we will try to check the effect of it on athletic performance whether it will increase or not, by checking Vital Parameters as in Methodology section, which is as follows:

1. VO2 Max

2. Electronic hand dynamometer test

3. Muscular Endurance Test – Push ups, curl ups

4. Flexibility test – Sit and Reach test,

5. Speed test for runners, how much time to take for 100 m and 400 m running

 

 

 
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