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CompletedNCT02834715STEDIA1Updated Jan 24, 2017

Metabolic Effects of Stevia in Type 2 Diabetic Patients

An interventional study of Stevia rebaudiana liquid extract in Diabetes Mellitus, sponsored by Yaounde Central Hospital. Completed at 1 site in Cameroon. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-24.

Sponsored by Yaounde Central Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
21 Years to 75 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Diabetes
  • Stevia
  • insulin secretion
  • insulin sensitivity
  • Sweetener
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 22 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Yaounde Central Hospital is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Infection up to 10 days prior to inclusion
  • Serum ALAT >3N,
  • MDRD estimated creatinine clearance \<60ml/min
  • Tobacco smoking
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
22 participants (actual)

Study arms

  • 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

  • No intervention
    Control

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

Interventions

  • Dietary supplementStevia rebaudiana liquid extract

    Sweetener made of liquid stevia self administered daily for 30 days

06

What researchers measure

Primary outcomes

  1. Glycaemic profile in response to mixed meal test

    Change in blood glucose profile during a mixed meal test at baseline and after one month intervention

    Time frame: 1 month

Secondary outcomes

  1. insulin secretion in response to mixed meal test

    Change in serum C-peptide profile during a mixed meal test at baseline and after one month intervention

    Time frame: 1 month

  2. Serum lipids

    Change in fasting serum lipids

    Time frame: 1 month

  3. Insulin sensitivity

    Change in mixed meal derived insulin sensitivity

    Time frame: 1 month

  4. Liver enzymes

    Change in serum alanine amino transferase

    Time frame: 1 month

07

Study locations

1 site
  • National Obesity Centre
    Yaounde, Cameroon
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02834715
Lead sponsor
Yaounde Central Hospital
Responsible party
Sobngwi Eugene (Professor, Yaounde Central Hospital) — Principal investigator
First posted
Jul 15, 2016
Start date
Mar 2016
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Jan 24, 2017

Study contacts

Eugene Sobngwi, MD, PhD
principal investigator · University of Yaoundé 1 and Yaoundé Central Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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