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CTRI Number  CTRI/2023/07/055715 [Registered on: 26/07/2023] Trial Registered Prospectively
Last Modified On: 25/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effect of grape polyphenol extract supplementation on improving cognition in older healthy adults 
Scientific Title of Study   Vegetarianism And Grape Polyphenol Extract Supplementation On Cognition And Neuropsychological Status Of Healthy Adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Keotshepile Precious Bojang 
Designation  Research Scholar 
Affiliation  University of Hyderabad 
Address  School of Medical Sciences Active and Healthy Ageing Research lab University of Hyderabad Gachibowli Hyderabad

Hyderabad
TELANGANA
500046
India 
Phone  8520857811  
Fax    
Email  21muph02@uohyd.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr M Varalakshmi 
Designation  Assistant Professor 
Affiliation  University of Hyderabad 
Address  School of Medical Sciences Active and Healthy Ageing Research lab University of Hyderabad Gachibowli Hyderabad

Hyderabad
TELANGANA
500046
India 
Phone  9441275157  
Fax    
Email  lakshmi@uohyd.ac.in  
 
Details of Contact Person
Public Query  
Name  Keotshepile Precious Bojang 
Designation  Research Scholar 
Affiliation  University of Hyderabad 
Address  School of Medical Sciences Active and Healthy Ageing Research lab University of Hyderabad Gachibowli Hyderabad

Hyderabad
TELANGANA
500046
India 
Phone  8520857811  
Fax    
Email  21muph02@uohyd.ac.in  
 
Source of Monetary or Material Support  
N/A 
 
Primary Sponsor  
Name  Keotshepile Precious Bojang 
Address  School of Medical Sciences University of Hyderabad Gachibowli Hyderabad 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SAILAJA  SERILLINGAMPALLY PRIMARY HEALTH CENTRE  MEDICAL OFFICER GULMOHAR PARK CROSS ROAD ARDASH NAGAR SERILLINGAMPALLY 500019
Hyderabad
TELANGANA 		 07396214724

nrithiksreeansh.keerthi@gmail.com 
KEOTSHEPILE PRECIOUS BOJANG  University of Hyderabad  SCHOOL OF MEDICAL SCIENCES UNIVERSITY OF HYDERABAD GACHIBOWLI 500046
Hyderabad
TELANGANA 		 8520857811

21muph02@uohyd.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
SERILLINGAMPALLY PRIMARY HOSPITAL  No Objection Certificate 
UNIVERSITY OF HYDERABAD INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Preventative interventions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Grape polyphenol extract supplementation  Subjects will be randomized to consume either a placebo (control) or an active grape formulation (intervention) which will be the freeze-dried grape powder made from commercially grown grape seeds. The type and amount of phytochemicals in the freeze-dried grape powder will be analyzed first and will be individually packaged and labelled in small clear less packets. Participants will receive a daily supply of powder packets (5 days a week) and will be asked to add 8 oz. water to a packet composed of 1mg/body weight e.g 70mg for an adult weighing 70kg, and consume once a day for 3 months. 
Comparator Agent  Placebo   Subjects will be randomized to consume either an active grape formulation or a placebo formulation matched in appearance, flavor, smell, volume and free of polyphenols. The placebo powder will be individually packaged and labelled in small clearless packets. Participants will receive a daily supply of powder packets (5 days a week) and will be asked to add 8 oz. water to a packet composed of 1mg/body weight e.g 70mg for an adult weighing 70kg, and consume once a day for 3 months.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  89.00 Year(s)
Gender  Both 
Details  MMSE score ≥23
Willing to participate and giving informed consent.
Speaks and understand English and Telugu.
Subjects with no history of renal diseases. 
 
ExclusionCriteria 
Details  Subjects with severe cognitive impairment and prior cardiovascular and chronic diseases.
Subjects with acute psychiatric or neurological disease or those taking psychiatric and cognitive functioning medication. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The subjects will get free nutritional screening & body composition analysis so as to help them make informed food choices to improve their cognition & help prevent the early occurrences of diseases like Dementia and Alzheimer’s. The post assessments will also be done to help improve cognition for those participants with mild dementia or memory loss. After receiving the grape polyphenol extract supplementation, older adults will have improved cognition , neuropsychological health and better quality of life.  12 weeks after the intervention schedule 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 1/ Phase 2 
Date of First Enrollment (India)   07/08/2023 
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="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 - NO
Brief Summary  

Ageing is a common process that is connected with deteriorating health status and diet is one of the modifiable factors for preventing age-related diseases and preserving overall good health status during aging. Premature chronic diseases in older adults can be prevented by nutrition education and diet interventions. Polyphenols, which are derived from fruits and vegetables have antioxidants, antibacterial, anti-aging, anticancer, antidiabetic and anti-inflammatory properties. Furthermore, inflammation and oxidative stress play a huge role in cognitive decline, which eventually leads to age related diseases like dementia and Alzheimer’s, therefore, this intervention  will utilize the  polyphenol extract from fresh grape seeds which have natural compounds such as resveratrol known for their antioxidant and anti-inflammatory properties to improve the cognitive function as well as the neuropsychological status of adults in Hyderabad. This randomized trial will have both the pilot and main study, with the first phase of the study being an observational study to assess the effect of vegetarianism in cognition and neuropsychological status of healthy status.

 
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