| CTRI Number |
CTRI/2024/12/078505 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Food ( Fibre Rich Smoothies)] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of diverse, plant intrinsic fibre formulations on gut microbiome and metabolic fitness. |
|
Scientific Title of Study
|
Ex-vivo and in vivo effects of plant intrinsic fibre drink on the
gut microbiome of healthy and metabolic syndrome subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PF/CR/1/24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhur Motwani |
| Designation |
CEO and Co-Founder |
| Affiliation |
Proxi Farma Pvt Ltd |
| Address |
Proxi Farma Pvt Ltd, 100 NCL Innovation Park Venture Centre, Dr Homi Bhabha Road Pashan Pune 411008
Pune
MAHARASHTRA
411008
India |
| Phone |
9096679269 |
| Fax |
|
| Email |
madhur.motwani@potion1st.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhur Motwani |
| Designation |
CEO and Co-Founder |
| Affiliation |
Proxi Farma Pvt Ltd |
| Address |
Proxi Farma Pvt Ltd, 100 NCL Innovation Park Venture Centre, Dr Homi Bhabha Road Pashan Pune 411008
MAHARASHTRA
411008
India |
| Phone |
9096679269 |
| Fax |
|
| Email |
madhur.motwani@potion1st.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhur Motwani |
| Designation |
CEO and Co-Founder |
| Affiliation |
Proxi Farma Pvt Ltd |
| Address |
Proxi Farma Pvt Ltd, 100 NCL Innovation Park Venture Centre, Dr Homi Bhabha Road Pashan Pune 411008
MAHARASHTRA
411008
India |
| Phone |
9096679269 |
| Fax |
|
| Email |
madhur.motwani@potion1st.com |
|
|
Source of Monetary or Material Support
|
| Startup India Seed Fund and CSR Grants,
Entrepreneurship Development Center,
NCL Innovation Park, Dr Homi Bhabha Road,
Pashan Pune 411008
Maharashtra, INDIA |
|
|
Primary Sponsor
|
| Name |
Proxi Farma Pvt Ltd |
| Address |
Proxi Farma Pvt Ltd, Office no. 14/16, Building no. A4, Dreamzland Business Park, Amravati, Maharashtra, 444707 |
| Type of Sponsor |
Other [Nutrition Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhur Motwani |
Proxi Farma Pvt Ltd |
100 NCL Innovation Park,
Dr Homi Bhabha Road,
Pashan
Pune
MAHARASHTRA |
9096679269
madhur.motwani@potion1st.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAHYADRI HOSPITALS PRIVATE LIMITED BIOMEDICAL AND HEALTH RESEARCH COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers
|
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Potion1st Fibre Rich Smoothies |
Fibre rich freeze dried formulations, prepared by mixing 3-4 freeze dried, everyday, fibre rich fruits and vegetables to ensure diverse fibre subtype in each smoothie. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participant Inclusion Criteria (Healthy Volunteers)
a. Between 25 to 60 years of age
b. Healthy volunteers with no diagnosed chronic disorder.
c. Those willing to abide by the requirements and conditions of the study and agreeing to
provide written informed consent
Participant Inclusion Criteria (Metabolic Syndrome)
a. Patients of either sex diagnosed with metabolic syndrome with three or more of the
following criteria as per NCEP/ ATP III, and not currently on any medications, as the trial
aims to assess the efficacy of dietary intervention alone.
i. Abdominal obesity: Having a waist circumference greater than 40 inches for
men and 35 inches for women when measured at the umbilical region.
ii. Elevated Blood Pressure: Having systolic blood pressure of 130 mm Hg or
higher, or diastolic blood pressure of 85 mm Hg or higher.
iii. High Blood Glucose Levels: Having fasting plasma glucose levels above 110
mg/dL
iv. Triglyceride Levels: Having elevated triglyceride levels of 150 mg/dL or higher.
v. Low HDL Cholesterol Levels: Having low HDL cholesterol levels below 40
mg/dL for men and below 50 mg/dL for women.
b. Between 25 and 60 years of age
c. Those willing to abide by the requirements and conditions of the study and agreeing to
provide written informed consent |
|
| ExclusionCriteria |
| Details |
Participant Exclusion Criteria
(for both Healthy and Metabolic Syndrome)
Exclusion criteria for participants of either group are the same as follows:
1. Currently on any medication.
2. Known allergies to any food product.
3. Pregnant or lactating women.
4. Individuals with any malignant disorder currently or in the past.
5. Individuals with psychiatric disorders or those with substance abuse.
6. Individuals who have been on antibiotics in the last 3 months.
7. Participants who have been involved in any other clinical trial within the last 6
months.
8. Participants who have undergone major surgery within the last 6 months.
9. Participants who have experienced significant weight changes (more than 5% of
body
weight) in the past 3 months.
10. Individuals consuming more than 14 units of alcohol per week for women and
more than 21 units per week for men. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
For Part A: Compare the effect of freeze dried fibre rich fibre food on propensity to
generate microbiome derived metabolites specifically short chain fatty acids.
For Part B: To evaluate the effectiveness of the dietary intervention on gut health by
quantifying changes in the Gut Microbiome Health Index (GMHI). |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood biochemistry to assess metabolic health, estimation of microbiome metabolites |
Day 21 |
To study the correlation between the changes in gut microbiome induced
by high fibre foods by ex vivo incubation and following in vivo
administration. |
Day 21 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/01/2025 |
| 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="1"
Months="6"
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
|
The translational study, titled “Ex-vivo and in vivo effects of plant intrinsic fibre drink on the gut microbiome of healthy and metabolic syndrome subjectsâ€, investigates the impact of Potion1st Smoothie formulations on gut microbiome diversity and metabolic health biomarkers. Conducted in two parts, the study evaluates both ex vivo and in vivo effects of dietary fibers on the gut microbiome (GM). Part A analyzes microbiome changes and short-chain fatty acid (SCFA) production through the incubation of stool samples with fiber-rich formulations. Part B involves a 21-day intervention where participants consume three smoothies daily, before meals, to assess their effects on microbiome diversity, biomarkers of metabolic health, and systemic health parameters through stool and blood analyses.
The primary objective is to assess whether Potion1st Smoothie formulations enhance gut microbiome diversity and influence biomarkers of metabolic health. Additionally, the study seeks to determine if ex vivo findings reliably predict in vivo outcomes, offering a framework for rapid dietary fiber research. Secondary goals include profiling GM metabolites, evaluating blood biochemistry, and calculating the Gut Microbiome Health Index (GMHI). This dual-phase design emphasizes diverse plant fibers and aims to validate a model for studying the therapeutic potential of dietary interventions in improving gut and metabolic health. |