Stevia Extract and Glucose Homeostasis

May 7, 2021 updated by: Grace Farhat, Liverpool Hope University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom, L16 9JD
        • School of Health sciences, Liverpool Hope University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Water
250 ml of water mixed with 1g of citric acid.
Active Comparator: Sugar
65g of sugar dissolved in 250ml of water
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.
Experimental: Stevia
5g of stevia dissolved in 250ml of water
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glucose levels
Time Frame: 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
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
Time Frame: 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
Postprandial insulin levels will be measured two hours of the administration of a fixed meal
Area under the curve (AUC) for glucose
Time Frame: 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
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
Time Frame: VAS will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch.
Visual analogue scales
VAS will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool Hope University

Investigators

  • Study Chair: Farzad Amirabdollahian, PhD, Liverpool Hope University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2020

Primary Completion (Actual)

February 15, 2021

Study Completion (Actual)

February 15, 2021

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13022020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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