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

Y

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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