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CTRI Number  CTRI/2024/04/065449 [Registered on: 09/04/2024] Trial Registered Prospectively
Last Modified On: 07/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Study to understand the effect of the mushroom-based soup mix for diabetes control in pre diabetic patients. 
Scientific Title of Study   A single center, prospective, single arm, interventional, open labelled, pilot study to understand the efficacy of the intake of oyster mushroom-based soup mix for plasma glucose control in pre diabetic patients 
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 Dhaval Dalal 
Designation  Consultant General Physician 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD no 13, Ground Floor, Shrishti Complex, Bhaktivedanta Swami Marg, Mira Road (East), Thane, Maharashtra 401107, India.

Thane
MAHARASHTRA
401107
India 
Phone  9322220944  
Fax    
Email  drdalal.rns@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dhaval Dalal 
Designation  Consultant General Physician 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD no 13, Ground Floor, Shrishti Complex, Bhaktivedanta Swami Marg, Mira Road (East), Thane, Maharashtra 401107, India.

Thane
MAHARASHTRA
401107
India 
Phone  9322220944  
Fax    
Email  drdalal.rns@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Venkatesh Kereenhalli 
Designation  Director  
Affiliation  Metflux Research Private Limited 
Address  Ground floor, 39 Heera Panna Shopping center, AdiShankaracharya Marg, Powai mumbai, 400078

Mumbai
MAHARASHTRA
400078
India 
Phone  9820234251  
Fax    
Email  venks@iitb.ac.in  
 
Source of Monetary or Material Support  
Metflux Research Private Limited. Ground floor, 39 Heera Panna Shopping center, AdiShankaracharya Marg, Powai mumbai, 400078, Maharashtra, India  
 
Primary Sponsor  
Name  Metflux Research Private Limited  
Address  Ground Floor-39, Heera Panna Shopping Center, Adi shankarachraya Marg, Powai Mumbai,400078 
Type of Sponsor  Other [Medical Tech Startup] 
 
Details of Secondary Sponsor  
Name  Address 
Bhaktivedanta Hospital and Research Institute  Srishti Complex, Bhaktivedanta Swami Marg, Mira road east, Thane,401107, Maharashtra, India. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dhaval Dalal  Bhaktivedanta Hospital and Research Institute  OPD No. 13,Ground Floor ,Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road, Maharashtra, India, 401107
Thane
MAHARASHTRA 
9322220944

drdalal.rns@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mushroom oyster Soup  In this study a product named “Mushroom Delight Healthy Soups” which is approved by FSSAI will be used as an intervention. This product is a formulation of three Pleurotus mushroom species which are edible and are consumed widely.The eligible patients will consume mushroom oyster soup daily 30 mins before dinner throughout the study duration 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of all genders, age group 18 to 60 years
2. Patients with HbA1c level between 5.8% and 6.4%.
3. Participants must be drug-naive diabetics (i.e., those who have not previously received any pharmacological treatment for diabetes) or diabetics who are not currently on any oral hypoglycemic agents (OHA).
4. Patients who are willing to not take the medication during the study period. 
 
ExclusionCriteria 
Details  1. Patients with HbA1C less than 5.8% and more than 6.4%
2. Patients who are prescribed medications for sugar control
3. Pregnant and lactating women, patients with untreated thyroid disease
4. Patients with any use of or has a history of drug and/or alcohol abuse
5. Patients with psychiatric or mental disorders 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the changes in HbA1c and lipid level of the patients post consumption of mushroom oyster soup. To evaluate the changes in lifestyle behavior of the patients post consumption of mushroom oyster soup.  on Day 45 and on day 90 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   16/04/2024 
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="3"
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
Modification(s)  

Diabetes Mellitus is a metabolic disorder where the intrinsic glucose control of the body is disturbed and therefore the regulation on how body converts food into energy is lost. It is a chronic disease and there are millions of people who are living with the disease. Mushroom derived functional foods and dietary supplements with bioactive compounds have been shown to help towards the treatment, management, and prevention of the type 2 diabetes. Many mechanistic views for this process has been proposed such as slow breakdown of polysaccharides, inhibition of enzymes amylase and glucosidase, increase in beta cell proliferation, decreased absorption of carbohydrates, increase in glycogen synthesis, increase in insulin signaling etc., towards alleviation of symptoms of Type 2 diabetes. For many of the edible mushroom varieties there are many proven health benefits and one of them is their anti-diabetic potential.

A initial pilot study was conducted using the product “Mushroom Delight” in 10 patients, the results showed a decrease in fasting blood glucose and post prandial levels in patients who are newly or pre diabetic.

This study will provide a systematic analysis and have a control set where the benefit due to the mushroom soup can be quantified and analyzed.

Study Rationale:Understand the capability of the formulated oyster mushroom mix soup to effectively control the blood sugar levels.

Objectives of the study is to evaluate impact of study product on HbA1c, blood sugar level, lipid profile levels. 

Inclusion Criteria for the study includes Patients of all genders, age group 18 to 60 years, with HbA1c level between 5.8% and 6.4%. The participants must be drug-naive diabetics (i.e., those who have not previously received any pharmacological treatment for diabetes) or diabetics who are not currently on any oral hypoglycemic agents (OHA). patients who are willing to not take the medication during the study period..    

Exclusion Criteria includes Patients with HbA1C less than 5.8% and more than 6.4%. Patients who are prescribed medications for sugar control. Pregnant and lactating women, patients with untreated thyroid disease. Patients with any use of or has a history of drug and/or alcohol abuse. Patients with psychiatric or mental disorders

Withdrawal criteria for study is Patient will be withdrawn if the sugar levels increase dramatically, and the patient is suggested by the doctor to be on medication. Patients who have allergy to mushrooms and have gastrointestinal trouble due to the consumption of mushroom soup.

Blood investigation for study  Fasting blood glucose levels (FBG),   HbA1C levels,Post prandial glucose concentrations,Lipid profile

        The patient will visit the hospital in following time point during which the above mentioned blood test will be performed: Visit 2 (Day 45 ± 7) and a)    Visit 3_End of the treatment (Day 90 ± 7)

Data parameters for study: Demographic details, Type of diet  (Vegetarian/Non Vegetarian/  Eggetarian/ Vegan), Physical Assessment (Height, Weight, BP), Fasting blood glucose levels (FBG), HbA1C levels, Post prandial glucose concentrations, Lipid profile.Duration of the study is 3 months.

Endpoints of the study is to evaluate the changes in HbA1c and lipid level of the patients post consumption of mushroom oyster soup. To evaluate the changes in lifestyle behavior of the patients post consumption of mushroom oyster soup.

 

 
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