Stevia Extract and Glucose Homeostasis

Not Applicable

Withdrawn

• Conditions: Obesity; Overweight
• Interventions: Other: sugar replacements

• Registration Number: NCT04335565
• Lead Sponsor: Liverpool Hope University

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.

Study Timeline

• Study Start: 2020-03-03
• Status Verified: 2020-04
• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-06
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-15
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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...).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Stevia	sugar replacements	5g of stevia dissolved in 250ml of water
Sugar	sugar replacements	65g of sugar dissolved in 250ml of water

Primary Outcome Measures

Name	Time	Method
Postprandial glucose levels	Capillary blood glucose will be measured two hours after the administration of a fixed meal.	Change in glucose levels two hours after the administration of a fixed meal

Secondary Outcome Measures

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

Trial Locations

Locations (1)

School of Health sciences, Liverpool Hope University; 🇬🇧 Liverpool, United Kingdom