| 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
|
|
|
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.
|