Stevia Extract and Glucose Homeostasis

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the effect of stevia extract on postprandial glucose and insulin levels in overweight and obese adults when compared to sugar and water.

Detailed Description
-----------------
The study is a three-arm crossover trial involving participants attending the Lab on 3 different occasions (separated by 3-5 day washout period), where they will be administered water, sugar solution (65g), water and stevia extract (5g) solution. The solution will be followed by a consumption of a fixed meal (after 30 minutes). Breakfast will be standardised. Capillary blood glucose will be collected every 30 min until 2 hours post meal. Venous blood samples will be collected before the intake of the solution and at 2 hours after meal intake.

Official Title
-----------------
Effect of Stevia Extract on Postprandial Glucose Response and Satiety in Overweight and Obese Adults: A Three-arm Crossover Trial.

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Other: sugar replacements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 years BMI 27-40 Kg/m2 Males and females Exclusion Criteria: Athletes Pregnant or breastfeeding women Patients with chronic disease (diabetes, CVD etc…).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Water<br>250 ml of water mixed with 1g of citric acid. | |
| Active Comparator: Sugar<br>65g of sugar dissolved in 250ml of water | Other: sugar replacements<br>* Participants will receive a solution of stevia before being administered a fixed meal (lunch). Glucose and insulin levels, and Visual analogue scale data will be collected.<br>|
| Experimental: Stevia<br>5g of stevia dissolved in 250ml of water | Other: sugar replacements<br>* Participants will receive a solution of stevia before being administered a fixed meal (lunch). Glucose and insulin levels, and Visual analogue scale data will be collected.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose levels | Change in glucose levels two hours after the administration of a fixed meal | Capillary blood glucose will be measured two hours after the administration of a fixed meal. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial insulin levels | Change in postprandial insulin levels two hours after the administration of a fixed meal | Postprandial insulin levels will be measured two hours of the administration of a fixed meal | 
| Area under the curve (AUC) for glucose | Changes in AUC for glucose throughout the intervention | Capillary blood glucose levels will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch | 
| Subjective feelings of satiety | Visual analogue scales | VAS will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-nutritive sweeteners, postprandial glucose, diabetes, obesity, satiety