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

NCT ID: NCT06645002

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-22

Study Completion Date

2025-02-22

Brief Summary

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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

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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short term study

short term study (7 days) stevia leave powder 1000 mg/day

Group Type EXPERIMENTAL

stevia rebaudiana bertoni

Intervention Type DIETARY_SUPPLEMENT

effect of short term study (7 days) of stevia leave powder 1000 mg/day in diabetic subjects

long term study

Long term study (60 days) stevia leave powder 1000 mg/day

Group Type EXPERIMENTAL

stevia rebaudiana bertoni

Intervention Type DIETARY_SUPPLEMENT

effect of short term study (7 days) of stevia leave powder 1000 mg/day in diabetic subjects

stevia rebaudiana bertoni

Intervention Type DIETARY_SUPPLEMENT

effect of long term study (60 days) of stevia leave powder 1000 mg/day in diabetic subjects

Interventions

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stevia rebaudiana bertoni

effect of short term study (7 days) of stevia leave powder 1000 mg/day in diabetic subjects

Intervention Type DIETARY_SUPPLEMENT

stevia rebaudiana bertoni

effect of long term study (60 days) of stevia leave powder 1000 mg/day in diabetic subjects

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allied Hospital Faisalabad

OTHER

Sponsor Role collaborator

University of Lahore

OTHER

Sponsor Role lead

Responsible Party

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Fasiha Ahsan

PhD scholar

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Allied Hospital Faisalabad

Faisalabad, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Ritu M, Nandini J. Nutritional composition of Stevia rebaudiana, a sweet herb, and its hypoglycaemic and hypolipidaemic effect on patients with non-insulin dependent diabetes mellitus. J Sci Food Agric. 2016 Sep;96(12):4231-4. doi: 10.1002/jsfa.7627. Epub 2016 Feb 22.

Reference Type BACKGROUND
PMID: 26781312 (View on PubMed)

Other Identifiers

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IRB-UOL-FAHS/774/2020

Identifier Type: -

Identifier Source: org_study_id

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