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Chickpea Pulao Using Fenugreek Seeds and Indian Rennet for Improving Blood Glycaemic Levels (DP-Trails)

Primary Purpose

Glucose Metabolism Disorders (Including Diabetes Mellitus)

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Fenugreek Seeds and Indian Rennet
Sponsored by
University of Management and Technology Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Metabolism Disorders (Including Diabetes Mellitus) focused on measuring Chickpea pulao, Fenugreek seeds, Indian rennet, Glucose modulating

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: People having Type-2 diabetes disease Must be able to consume chickpea rice pulao Must not be on vegan or keto diet Exclusion Criteria: Healthy people without diabetes People with less than 18 years of age

Sites / Locations

  • University of Management and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Typical rice pulao without and herbal intervention

Chickpea Pulao Using Fenugreek Seeds and Indian Rennet

Arm Description

Normal chickpea rice pulao was used as the main arm. The control group does not contain fenugreek and Indian rennet extract.

Chickpea rice pulao added with herb (Fenugreek Seeds and Indian Rennet).

Outcomes

Primary Outcome Measures

Improvement in blood glucose levels
Increase or decrease in postprandial glucose levels in mg/dL.

Secondary Outcome Measures

Full Information

First Posted
October 1, 2023
Last Updated
October 17, 2023
Sponsor
University of Management and Technology Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT06095622
Brief Title
Chickpea Pulao Using Fenugreek Seeds and Indian Rennet for Improving Blood Glycaemic Levels
Acronym
DP-Trails
Official Title
Formulation and Assessment of Chickpea Pulao Using Fenugreek Seeds and Indian Rennet for Improving Blood Glycemic Levels
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Management and Technology Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this study was to perform a clinical trial to compare the impact of herbal chickpea pulao (cooked Indian-Pakistani rice dish) on improving postprandial blood glucose levels in type-2 diabetic people. The main questions it aims to answer are: Whether Indian rennet and fenugreek seed extract can modulate blood sugar levels or not? At what concentration the flavor, taste, and blood sugar impact were acceptable? Participants were provided with control and intervention herbal chickpea pulao for a period of 21 days and asked to provide feedback on taste, flavor, and over-acceptability, and their postprandial blood glucose levels were checked.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Keywords
Chickpea pulao, Fenugreek seeds, Indian rennet, Glucose modulating

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Typical rice pulao without and herbal intervention
Arm Type
No Intervention
Arm Description
Normal chickpea rice pulao was used as the main arm. The control group does not contain fenugreek and Indian rennet extract.
Arm Title
Chickpea Pulao Using Fenugreek Seeds and Indian Rennet
Arm Type
Experimental
Arm Description
Chickpea rice pulao added with herb (Fenugreek Seeds and Indian Rennet).
Intervention Type
Dietary Supplement
Intervention Name(s)
Fenugreek Seeds and Indian Rennet
Intervention Description
Food herbs like fenugreek Seeds and Indian rennet to formulate rice dish.
Primary Outcome Measure Information:
Title
Improvement in blood glucose levels
Description
Increase or decrease in postprandial glucose levels in mg/dL.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People having Type-2 diabetes disease Must be able to consume chickpea rice pulao Must not be on vegan or keto diet Exclusion Criteria: Healthy people without diabetes People with less than 18 years of age
Facility Information:
Facility Name
University of Management and Technology
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The results data collected, de-identified individual participant data, and composition of recipe will be shared.
IPD Sharing Time Frame
6 months after the publication of the manuscript.
IPD Sharing Access Criteria
The data can be requested from the corresponding author.

Learn more about this trial

Chickpea Pulao Using Fenugreek Seeds and Indian Rennet for Improving Blood Glycaemic Levels

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