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

NCT06645002 | Enrolling By Invitation

• 1 other identifier: IRB-UOL-FAHS/774/2020
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes

Keywords

Diabetes; Stevia; Glucose; Lipid profile

Outcome Measures

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.

  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

  Short term study (7 days) long term study (60 days)

Study Arms (2)

short term study

EXPERIMENTAL

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

Dietary Supplement: stevia rebaudiana bertoni

long term study

EXPERIMENTAL

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

Dietary Supplement: stevia rebaudiana bertoni

Interventions

stevia rebaudiana bertoni DIETARY_SUPPLEMENT

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

long term study; short term study

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead
• Allied Hospital Faisalabad: collaborator

Study Sites (1)

Allied Hospital Faisalabad

Faisalabad, Punjab Province, 38000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 26781312 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD scholar

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 16, 2024
• Study Start: August 22, 2024
• Primary Completion: November 22, 2024
• Study Completion: February 22, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)