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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка stevia rebaudiana bertoni
  effect of short term study (7 days) of stevia leave powder 1000 mg/day in diabetic subjects
• Пищевая добавка stevia rebaudiana bertoni
  effect of long term study (60 days) of stevia leave powder 1000 mg/day in diabetic subjects

Первичные конечные точки

• To compare the effects of short and long-term treatment of stevia powder capsules on blood glucose levels among diabetic patients [Срок оценки: Short term study (7 days) long term study (60 days)]

Вторичные конечные точки (1)

• To compare the effects of short and long-term treatment of stevia powder capsules on lipid profile and LFTs among diabetic patients [Срок оценки: Short term study (7 days) long term study (60 days)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Allied Hospital Faisalabad — Faisalabad

Публикации

• 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

Идентификаторы

NCT: NCT06645002 · IRB-UOL-FAHS/774/2020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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