Metabolic Effects of Stevia in Type 2 Diabetic Patients (STEDIA1)

January 23, 2017 updated by: Sobngwi Eugene, Yaounde Central Hospital

Effects of Stevia on Glycaemic Profile and Insulin Secretion of Type 2 Diabetic Patients

The main aim of the study is to assess the short term and 1-month metabolic effects of Stevia rebaudiana bertoni in patients with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a non-randomized clinical trial in a type 2 diabetic population aiming to investigate the effect of Stevia rebaudiana bertoni on the glycaemic and insulin secretory response to a mixed meal tolerance test, insulin sensitivity and lipid profile. The study has two arms including an intervention arm (test group) and a non-intervention arm (controls) matched for age, sex and body mass index in 2:1 ratio.

The intervention is made of two phases including

  1. A mixed meal tolerance test with and without 240 mg of Stevia in a randomized order to evaluate the acute effects;
  2. An oral intake of 240 mg of Stevia within 30 days as food supplement in order to assess medium-term effects

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
      • Yaounde, Cameroon
        • National Obesity Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Known type 2 diabetes
  • Unchanged hypoglycaemic treatment for at least 3 months prior to inclusion
  • No acute complication of diabetes
  • HbA1C≤ 8%

Exclusion Criteria:

  • Infection up to 10 days prior to inclusion
  • Serum ALAT >3N,
  • MDRD estimated creatinine clearance <60ml/min
  • Tobacco smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stevia
Once-daily oral intake of 240 mg of Stevia liquid extract for 30 days as food supplement.
Dietary supplement: Stevia rebaudiana liquid extract
Sweetener made of liquid stevia self administered daily for 30 days
No Intervention: Control
No intervention, similar follow up as experimental arm to control for trial effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycaemic profile in response to mixed meal test
Time Frame: 1 month
Change in blood glucose profile during a mixed meal test at baseline and after one month intervention
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insulin secretion in response to mixed meal test
Time Frame: 1 month
Change in serum C-peptide profile during a mixed meal test at baseline and after one month intervention
1 month
Serum lipids
Time Frame: 1 month
Change in fasting serum lipids
1 month
Insulin sensitivity
Time Frame: 1 month
Change in mixed meal derived insulin sensitivity
1 month
Liver enzymes
Time Frame: 1 month
Change in serum alanine amino transferase
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yaounde Central Hospital

Investigators

  • Principal Investigator: Eugene Sobngwi, MD, PhD, University of Yaoundé 1 and Yaoundé Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 8, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CNO20161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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