Stevia Extract and Glucose Homeostasis

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04335565
• Other study ID #: 13022020
• Status: Withdrawn
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: April 2020
• Source: Liverpool Hope University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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…).

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• sugar replacements
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.

Locations

Country	Name	City	State
United Kingdom	School of Health sciences, Liverpool Hope University	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool Hope University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Farhat G, Berset V, Moore L. Effects of Stevia Extract on Postprandial Glucose Response, Satiety and Energy Intake: A Three-Arm Crossover Trial. Nutrients. 2019 Dec 12;11(12). pii: E3036. doi: 10.3390/nu11123036. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.