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CTRI Number  CTRI/2024/06/069665 [Registered on: 28/06/2024] Trial Registered Prospectively
Last Modified On: 27/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   The impact of red and green spinach extract on performance and strength in physically active individuals. 
Scientific Title of Study   A clinical study to evaluate the impact of red and green spinach extract on performance, strength, stamina, and reducing muscle breakdown as well as promoting muscle synthesis in physically active individuals. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/23-24/039 Version 1.00; dated 03 Feb 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh Kharade 
Designation  Principal Investigator 
Affiliation  Sangvi Multispeciality Hospital Pvt. Ltd 
Address  OPD room no 01 1st Floor Krushna Chowk, Sangvi

Pune
MAHARASHTRA
411027
India 
Phone  9421901141  
Fax  -  
Email  sr.feasibility@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Anirudh Mehta 
Designation  Director 
Affiliation  Phytoveda Pvt. Ltd 
Address  6/10 Jogani Industrial Complex N. Purav Marg Chunabhatti

Mumbai
MAHARASHTRA
400022
India 
Phone  9820031562  
Fax  -  
Email  adme@phytoveda.in  
 
Details of Contact Person
Public Query  
Name  Mr Anirudh Mehta 
Designation  Director 
Affiliation  Phytoveda Pvt. Ltd 
Address  6/10 Jogani Industrial Complex N. Purav Marg Chunabhatti

Mumbai
MAHARASHTRA
400022
India 
Phone  9820031562  
Fax  -  
Email  adme@phytoveda.in  
 
Source of Monetary or Material Support  
Phytoveda Pvt. Ltd. 6/10 Jogani Industrial Complex, N. Purav Marg, Chunabhatti, Mumbai-400022 
 
Primary Sponsor  
Name  Phytoveda Pvt. Ltd. 
Address  6/10 Jogani Industrial Complex, N. Purav Marg, Chunabhatti,Mumbai-400022  
Type of Sponsor  Other [Nutraceutical] 
 
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 Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital  OPD room no 401 Fourth Floor 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com 
Dr Mahesh Kharade   Sangvi Multispeciality Hospital Pvt. Ltd  OPD room no 01 First Floor Krushna Chowk, Sangvi
Pune
MAHARASHTRA 		 9421901141
-
sr.feasibility@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Sangvi Multispeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Red and green spinach extract capsules  Two 500 mg capsules (Each containing 250 mg of red spinach extract and 250 mg of green spinach extract) in sequence 30-60 minutes prior to exercise once a day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Male and female participants aged between 18-40 years having BMI less than 35 kg/m2 2.Resting blood pressure averaging less than 140/90 mmHg 3.Not on any medication for cardiovascular and metabolic disorders 4.Engaged in regular resistance training (comprising of cardio and strength training) for at least 1 year and willing to continue the same during the study 5.Participants consuming whey protein and possess a sufficient level of knowledge regarding the importance of dietary and lifestyle factors relevant to the study, as determined by the investigator 6.Willing to provide consent and come for regular follow-up visits.  
 
ExclusionCriteria 
Details  1.Participants with any acute illness requiring immediate medical care;
2.Participants with any chronic medical condition;
3.Participants with sedentary lifestyles are not able or not advised to undergo the resistance training as per protocol;
4.Any clinically relevant macro or micro-nutrient deficiency as per investigator discretion;
5.Any other condition which proves the participant unfit for the study participation;
6.Any known cardiovascular or metabolic disease;
7.Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test;
8.Participants who are taking any herbal nutraceutical supplements except plant-based protein supplementation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Evaluate the impact of red and green spinach extract on physical performance, subjective measures like exertion and muscle fatigue, and physical measures, cardiorespiratory health and endurance, anthropometric measurements, hypertrophy, and body composition over a 8-week in physically active individuals.
2.Assess the efficacy of red and green spinach extract on changes in muscle strength, biochemical markers, recovery from exercise and laboratory investigations in physically active individuals.
 		 Baseline, week 4 and week 8 
 
Secondary Outcome  
Outcome  TimePoints 
1.Adverse events profile.
2.Compliance and tolerability of the investigational product. 		 Baseline, week 4 and week 8
 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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 2 
Date of First Enrollment (India)   08/07/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The present study is designed to evaluate the effectiveness of a combination of red and green spinach extract in improving performance, strength, and stamina, and reducing muscle breakdown in physically active individuals. The rationale for conducting this study is multifaceted:

Intervention and Nutritional Approach: Spinach is known for its rich nutrient profile, including vitamins, minerals, and phytochemicals, which are believed to confer various health benefits. By harnessing the potential synergistic effects of red and green spinach extract, this study adopts a nutritional approach to enhancing physical performance and muscle health, offering a promising avenue for individuals looking to support their fitness goals.

Moreover, there is limited scientific literature on the specific effects of red and green spinach extract on physical performance and muscle health. As such, this study seeks to contribute to the body of knowledge by providing valuable insights into the potential benefits of this intervention.

To our knowledge, this study represents the first investigation on a global scale into the combined effects of red and green spinach extract on physical performance and muscle health. By exploring the potential short and long-term benefits of this intervention, the study aims to provide valuable insights that may have implications for individuals worldwide seeking to optimize their exercise performance and muscle mass.

 
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