NCT06095622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

October 1, 2023

Last Update Submit

October 17, 2023

Conditions

Keywords

Chickpea pulaoFenugreek seedsIndian rennetGlucose modulating

Outcome Measures

Primary Outcomes (1)

  • Improvement in blood glucose levels

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

    21 days

Study Arms (2)

Typical rice pulao without and herbal intervention

NO INTERVENTION

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

Chickpea Pulao Using Fenugreek Seeds and Indian Rennet

EXPERIMENTAL

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

Dietary Supplement: Fenugreek Seeds and Indian Rennet

Interventions

Food herbs like fenugreek Seeds and Indian rennet to formulate rice dish.

Chickpea Pulao Using Fenugreek Seeds and Indian Rennet

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People having Type-2 diabetes disease
  • Must be able to consume chickpea rice pulao
  • Must not be on vegan or keto diet

You may not qualify if:

  • Healthy people without diabetes
  • People with less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Management and Technology

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2023

First Posted

October 23, 2023

Study Start

March 15, 2023

Primary Completion

July 30, 2023

Study Completion

August 30, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

The results data collected, de-identified individual participant data, and composition of recipe will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
6 months after the publication of the manuscript.
Access Criteria
The data can be requested from the corresponding author.

Locations