| CTRI Number |
CTRI/2024/01/061780 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Food product] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Aim to Study blood Sugar or glucose spike of PRP-02 in Individuals with Compromised Blood Glucose Level |
|
Scientific Title of Study
|
Assessment of Postprandial Glycemic Response to PRP-02 in Individuals with Compromised Blood Glucose Levels: A non-randomized, Controlled, Crossover Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AMW/ CTP/EGS/12-2023,Version1.0 dated 27.12.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhu Sudan C |
| Designation |
Consultant Physician |
| Affiliation |
NRR Hospital |
| Address |
Unit no 101,102A,102B,103,104 and 105, Tower-A, SAS Tower, Medicity, Sector -38,Gurugram Haryana
OPD consultation Room No 2,Ground floor NRR HospitalChikkabanavara HesaragattaMain Road, Bangalore-560090Karnataka, India Bangalore
Bangalore
KARNATAKA
Bangalore
KARNATAKA
560090
India |
| Phone |
9731518867 |
| Fax |
|
| Email |
drmadhusudanmadhu123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Palaniyamma |
| Designation |
Senior Manager-Clinical Affairs and Nutrition, Innovation and Science-AGSI |
| Affiliation |
Amway Global Services India Pvt Ltd |
| Address |
Unit no 101,102A,102B,103,104 and 105, Tower-A, SAS Tower, Medicity, Sector -38,Gurugram Haryana
Gurgaon
HARYANA
122001
India |
| Phone |
7022247227 |
| Fax |
|
| Email |
Palaniyamma.Durairaj@Amway.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudha Raj |
| Designation |
Director |
| Affiliation |
CLINISYD Research Global Solutions Pvt Ltd |
| Address |
CLINISYD Research Global Solutions Pvt Ltd #1/1, 14th Cross, Malagala Main Rd,Malagala, Krishnananda Nagar, Naagarabhaavi, Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9481574797 |
| Fax |
|
| Email |
sudharaj@clinisydresearch.com |
|
|
Source of Monetary or Material Support
|
| Amway Global Services India Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Amway Global Services India Pvt Ltd |
| Address |
Unit No. 101-105, Tower A, SAS Tower Medicity, Sector 38, Gurgaon, Haryana122001 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Madhusudan |
NRR Hospital |
OPD consultation Room No 2,Ground floor NRR HospitalChikkabanavara HesaragattaMain Road, Bangalore-560090Karnataka, India Bangalore
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9886627611
drmadhusudanmadhu123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommitte,AshrayaMedinova Privatelimited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Glucose | 75-gram of reference product will be given on visit 2 | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:protein Supplement, Pathya/Apathya:yes, Pathya:The test product 0PRP-02 will be administered as 3 scoops (30 g) with 250 ml of buttermilk,, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Apparently healthy adults aged 30 to 50 years with normal blood pressure.
2) Participants meeting 2023 ADA guidelines, including fasting glucose levels of 100-125 mg per dl and HbA1c levels between 5.7 percent and 6 percent
3) Stable body mass with a BMI of less or equal30 kg per m2
4) No recent participation in other clinical trials within the past 3 months.
5) Individuals capable of understanding and committing to the study protocol, including follow-up visits.
|
|
| ExclusionCriteria |
| Details |
1) Current use of medication or Hormone Replacement Therapy (HRT).
2) Treatment with injectable therapies, including insulin, GLP 1 receptor agonists, SGLT 2 inhibitors, or metformin.
3) Allergies or intolerance to soy or wheat.
4) Diagnosed with endocrine hypothalamic-pituitary diseases, PCOS, adrenal disorders, or hypothyroidism.
5) Type 1 or Type 2 diabetes.
6) Reproductive-age women unwilling to use standard contraceptives.
7) Medical conditions such as CKD, stones, liver dysfunction, cancer history, eating disorders, chronic gastrointestinal disorders, hypertension, and cardiovascular diseases.
8) Active malignancy or remission for less than five years.
9) Recent surgical procedures within one month.
10) Participation in another clinical study within the past three months.
11) Doubts about the ability to comply with study procedures for mental, psychological, or social reasons.
12) Unwillingness to sign informed consent and adhere to the study protocol.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of postprandial glycemic response of PRP-02 in adult individuals |
Assessment of postprandial glycemic response of PRP-02 by measuring blood sugar levels at predetermined intervals (-10, 15, 30, 45, 60, 90, and 120 minutes) in comparison to a reference product (glucose) on visit 2( Day 1) and visit 3( Day 4) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Occurrence and severity of any adverse events during the study period |
Baseline and End of the study |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/01/2024 |
| Date of Study Completion (India) |
08/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Postprandial glycaemic response
refers to the changes in blood sugar levels after consuming a meal. PRP-02
seems to be a substance or intervention being tested in the trial
During acute feeding trials,
consuming a large dose of whey protein (WP) before meals improves postprandial
glucose regulation in people with type 2diabetes. It is unclear if the reported
benefits of premeal WP supplementation are translatable to everyday care or are
associated with clinically meaningful, real-world glycemic outcomes.
This study examined the
application of a novel, premeal shot containing a low dose of WP on parameters
of free-living glycemic control in people Healthy volunteers .
Purpose: The purpose of the
trial appears to be evaluating the impact of PRP-02 on postprandial glycemic
response in individuals with compromised blood glucose levels. This kind of
study aims to assess whether the intervention (PRP-02) has an effect on how the
body handles blood sugar levels after eating
|