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Enrolling by invitationNCT06645002DiabetesUpdated Oct 16, 2024

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

An interventional study of stevia rebaudiana bertoni and stevia rebaudiana bertoni in Diabetes, sponsored by University of Lahore. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-10-16.

Sponsored by University of Lahore · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
25 Years to 35 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Diabetes

Keywords

  • Diabetes
  • Stevia
  • Glucose
  • Lipid profile
03

In context

Lead sponsor

University of Lahore is the lead sponsor of 223 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    short term study

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

    Dietary Supplement: stevia rebaudiana bertoni

  • Experimental
    long term study

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

    Dietary Supplement: stevia rebaudiana bertoni

Interventions

  • Dietary supplementstevia rebaudiana bertoni

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

  • Dietary supplementstevia rebaudiana bertoni

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

06

What researchers measure

Primary outcomes

  1. To compare the effects of short and long-term treatment of stevia powder capsules on blood glucose levels among diabetic patients

    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.

    Time frame: Short term study (7 days) long term study (60 days)

Secondary outcomes

  1. To compare the effects of short and long-term treatment of stevia powder capsules on lipid profile and LFTs among diabetic patients

    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.

    Time frame: Short term study (7 days) long term study (60 days)

07

Study locations

1 site
  • Allied Hospital Faisalabad
    Faisalabad, Punjab 38000, Pakistan
08

References and documents

Publications

  • 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. PubMed 26781312 ↗

Individual participant data

Plan to share: No — Primary reason for not sharing the IPD is to protect participants privacy

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06645002
Lead sponsor
University of Lahore
Collaborators
Allied Hospital Faisalabad
Responsible party
Fasiha Ahsan (PhD scholar, University of Lahore) — Principal investigator
First posted
Oct 16, 2024
Start date
Aug 22, 2024
Primary completion
Nov 22, 2024 (estimated)
Completion
Feb 22, 2025 (estimated)
Last update
Oct 16, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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