Back to resultsStevia Extract and Glucose Homeostasis
Primary Purpose
Overweight, Obesity
Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
sugar replacements
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring Non-nutritive sweeteners, postprandial glucose, diabetes, obesity, satiety
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…).
Sites / Locations
- School of Health sciences, Liverpool Hope University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
Water
Sugar
Stevia
Arm Description
250 ml of water mixed with 1g of citric acid.
65g of sugar dissolved in 250ml of water
5g of stevia dissolved in 250ml of water
Outcomes
Primary Outcome Measures
Postprandial glucose levels
Change in glucose levels two hours after the administration of a fixed meal
Secondary Outcome Measures
Postprandial insulin levels
Change in postprandial insulin levels two hours after the administration of a fixed meal
Area under the curve (AUC) for glucose
Changes in AUC for glucose throughout the intervention
Subjective feelings of satiety
Visual analogue scales
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04335565
Brief Title
Stevia Extract and Glucose Homeostasis
Official Title
Effect of Stevia Extract on Postprandial Glucose Response and Satiety in Overweight and Obese Adults: A Three-arm Crossover Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The study has been terminated due to the pandemic.
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool Hope University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Non-nutritive sweeteners, postprandial glucose, diabetes, obesity, satiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Single (participant)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Water
Arm Type
No Intervention
Arm Description
250 ml of water mixed with 1g of citric acid.
Arm Title
Sugar
Arm Type
Active Comparator
Arm Description
65g of sugar dissolved in 250ml of water
Arm Title
Stevia
Arm Type
Experimental
Arm Description
5g of stevia dissolved in 250ml of water
Intervention Type
Other
Intervention Name(s)
sugar replacements
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postprandial glucose levels
Description
Change in glucose levels two hours after the administration of a fixed meal
Time Frame
Capillary blood glucose will be measured two hours after the administration of a fixed meal.
Secondary Outcome Measure Information:
Title
Postprandial insulin levels
Description
Change in postprandial insulin levels two hours after the administration of a fixed meal
Time Frame
Postprandial insulin levels will be measured two hours of the administration of a fixed meal
Title
Area under the curve (AUC) for glucose
Description
Changes in AUC for glucose throughout the intervention
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
Title
Subjective feelings of satiety
Description
Visual analogue scales
Time Frame
VAS will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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…).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farzad Amirabdollahian, PhD
Organizational Affiliation
Liverpool Hope University
Official's Role
Study Chair
Facility Information:
Facility Name
School of Health sciences, Liverpool Hope University
City
Liverpool
ZIP/Postal Code
L16 9JD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31842388
Citation
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):3036. doi: 10.3390/nu11123036.
Results Reference
background
Learn more about this trial
Stevia Extract and Glucose Homeostasis
We'll reach out to this number within 24 hrs