Clinical trial NCT06645002: Effect of Stevia Leave Powder on Blood Glucose and Lipid Profile of Diabetic Patients
Official title: Effect of Short and Long-Term Treatment of Stevia Leave Powder on Blood Glucose and Lipid Profile of Diabetic Patients.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Stevia
Glucose
Lipid profile
Lead sponsor: University of Lahore
Sponsor class: OTHER
Collaborators: name: Allied Hospital Faisalabad
First posted: 2024-10-16
Enrollment: 144
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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 \&gt;6% and blood sugar level \&gt;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

Primary outcomes:
measure: To compare the effects of short and long-term treatment of stevia powder capsules on blood glucose levels among diabetic patients
timeFrame: Short term study (7 days) long term study (60 days)
Secondary outcomes:
measure: To compare the effects of short and long-term treatment of stevia powder capsules on lipid profile and LFTs among diabetic patients
timeFrame: Short term study (7 days) long term study (60 days)
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Allied Hospital Faisalabad
state: Punjab
Study officials:
References:
citation: 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.