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

Yaounde Central Hospital

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Dietary Supplement: Stevia rebaudiana liquid extract

Study type: Interventional

Funder types: Other

Identifiers

NCT02834715

CNO20161

Details and patient eligibility

About

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.

Full 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

Enrollment: 22 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Stevia

Experimental group

Description:

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

Treatment:

Dietary Supplement: Stevia rebaudiana liquid extract

Control

No Intervention group

Description:

No intervention, similar follow up as experimental arm to control for trial effect