Metabolic Effects of Stevia in Type 2 Diabetic Patients

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Dietary Supplement: Stevia rebaudiana liquid extract

• Registration Number: NCT02834715
• Lead Sponsor: Yaounde Central Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-15
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stevia	Stevia rebaudiana liquid extract	Once-daily oral intake of 240 mg of Stevia liquid extract for 30 days as food supplement.

Primary Outcome Measures

Name	Time	Method
Glycaemic profile in response to mixed meal test	1 month	Change in blood glucose profile during a mixed meal test at baseline and after one month intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Obesity Centre; 🇨🇲 Yaounde, Cameroon