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

October 17, 2023 updated by: Nauman Khalid, University of Management and Technology Lahore

Formulation and Assessment of Chickpea Pulao Using Fenugreek Seeds and Indian Rennet for Improving Blood Glycemic Levels

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • University of Management and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Typical rice pulao without and herbal intervention
Normal chickpea rice pulao was used as the main arm. The control group does not contain fenugreek and Indian rennet extract.
Experimental: Chickpea Pulao Using Fenugreek Seeds and Indian Rennet
Chickpea rice pulao added with herb (Fenugreek Seeds and Indian Rennet).
Dietary supplement: Fenugreek Seeds and Indian Rennet
Food herbs like fenugreek Seeds and Indian rennet to formulate rice dish.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in blood glucose levels
Time Frame: 21 days
Increase or decrease in postprandial glucose levels in mg/dL.
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Management and Technology Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

October 1, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-03-R002-C-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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