Effect of Stevia Leave Powder on Blood Glucose and Lipid Profile of Diabetic Patients (Diabetes)

October 15, 2024 updated by: Fasiha Ahsan, University of Lahore

Effect of Short and Long-Term Treatment of Stevia Leave Powder on Blood Glucose and Lipid Profile of Diabetic Patients.

The goal of this clinical trial is to know if stevia leave powder capsule (1000 mg/day) will work to treat diabetes in participants. The main objectives it aims to answer are:

Does stevia decrease the blood glucose level in diabetic subjects that will use stevia powder capsule? Does stevia play its role in blood lipid profile in diabetic subjects that will use stevia powder capsule? The purpose of the study to see the impact of stevia in short (7 days) and long-term treatments (60 days) in diabetic subjects and compare the results

Diabetic subjects will:

Take stevia powder capsule every day for 7 days in short term study Take stevia powder capsule every day for 60 days in long term study

Check the biochemical assessment including blood glucose and lipid profile tests at 0 and 7th days in short term study Check the biochemical assessment including blood glucose and lipid profile tests at 0 and 30 and 60th days in long term study Keep a record of all the tests for comparison

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The selected participants will be randomly divided into placebo and treatment groups. The Initial (0-Day) data on anthropometric measurements and blood analysis on glucose, lipid levels and liver function tests (LFTs) will be carried out.

The balance diet plan will be prepared according to Pakistan dietary guidelines and given to all the study participants. Treatment stevia powder capsules will be provided to the participants for 7 days and for 60 days for short and long-term study respectively, for monitoring of compliance. Anthropometric measurements and biochemical assessments like blood glucose levels, lipid profile, insulin resistance and LFTs for short-term study will be measured at baseline, 7th and 60th day while, measurements of blood glucose, lipid profile, insulin resistance and LFTs will be carried out a baseline, 30, and 60 days for long-term study. In this research we will be analysed the effect of stevia powder capsules on diabetic patients for short and long term study.

Study Type

Interventional

Enrollment (Estimated)

144

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
      • Faisalabad, Punjab, Pakistan, 38000
        • Allied Hospital Faisalabad

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Inclusion Criteria: Individuals with the following conditions will be included as participants;

  • Patients of type 2 diabetes mellitus with the age range between 25-35 years from both genders
  • Diabetic patients without anti-diabetic drugs and their duration of diabetes no longer than 6 months
  • Diabetic patients with HbA1c >6% and blood sugar level >200 mg/dL

Exclusion Criteria:

Individuals with the following conditions were not included as participants;

  • Patients with nephropathy, retinopathy, diabetic foot, phenylketonuria, maple syrup urine disease
  • Participants with acute and chronic kidney disease, kidney stone,
  • Participants with history of acute liver injury (e.g., hepatitis) or severe cirrhosis
  • Diabetic patients with obesity, cardiovascular diseases, pregnancy
  • Participants taking nutritional supplements and other medicines

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: short term study
short term study (7 days) stevia leave powder 1000 mg/day
Dietary supplement: stevia rebaudiana bertoni
effect of short term study (7 days) of stevia leave powder 1000 mg/day in diabetic subjects
Dietary supplement: stevia rebaudiana bertoni
effect of long term study (60 days) of stevia leave powder 1000 mg/day in diabetic subjects
Experimental: long term study
Long term study (60 days) stevia leave powder 1000 mg/day
Dietary supplement: stevia rebaudiana bertoni
effect of short term study (7 days) of stevia leave powder 1000 mg/day in diabetic subjects
Dietary supplement: stevia rebaudiana bertoni
effect of long term study (60 days) of stevia leave powder 1000 mg/day in diabetic subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the effects of short and long-term treatment of stevia powder capsules on blood glucose levels among diabetic patients
Time Frame: Short term study (7 days) long term study (60 days)

Teatment group respondents of short term study will be received the stevia powder capsules of 1000mg for 7 days, this group includes the initial screening and assessment of subjects suffering from type-II diabetes. The subjects will also being studied for medical history and anthropometric parameters which include height and weight, BMI and biochemical parameters which include blood glucose levels of fasting, post-prandial, insulin resistance and HbA1c In addition, a dietary study will also be done by food diary method on 3 alternative days. The biochemical parameters of the subjects will be measured at 0, 7th and at 60th day.

Long-term treatment group participants will receive the treatment with 1000mg stevia powder in capsulated form once per day for 60 days, this group will also undergo the initial screening and assessment of anthropometric and biochemical parameters at 0, 30th and 60th day then will perform comparison analysis at 60th day for both short and long-term studies.
Short term study (7 days) long term study (60 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the effects of short and long-term treatment of stevia powder capsules on lipid profile and LFTs among diabetic patients
Time Frame: Short term study (7 days) long term study (60 days)
Treatment group respondents of short term study will be received the stevia powder capsules of 1000mg for 7 days, After initial assessment, BMI and blood glucose levels record, the lipid profile including, cholesterol, HDL, LDL and LFTs including ALT, AST will also be measured 0, 7th and at 60th day. Same tests will also be performed on long-term study participants and will measure the results at 0, 30 and 60th day of the study, then will perform comparison analysis at 60th day for both short and long-term studies.
Short term study (7 days) long term study (60 days)

Collaborators and Investigators

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

Sponsor

University of Lahore

Collaborators

Allied Hospital Faisalabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 22, 2024

Primary Completion (Estimated)

November 22, 2024

Study Completion (Estimated)

February 22, 2025

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-UOL-FAHS/774/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Primary reason for not sharing the IPD is to protect participants privacy

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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