Back to resultsSplenda: Effects on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake
Primary Purpose
Appetitive Behavior, Glucose Metabolism Disorders
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Splenda drink
Maltodextrin drink
High carbohydrate breakfast
Sponsored by
About this trial
This is an interventional basic science trial for Appetitive Behavior focused on measuring Blood glucose, Appetite, Energy intake
Eligibility Criteria
Inclusion Criteria: Healthy male and female adults (18-64 years) Exclusion Criteria: -
Sites / Locations
- King's College London
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Splenda drink
Maltodextrin drink
Arm Description
Drink containing 4.5g Splenda dissolved on 250ml water.
Drink containing 4.5g maltodextrin dissolved on 250ml water.
Outcomes
Primary Outcome Measures
Change in blood glucose
Capillary blood glucose from fingerprick and measured using glucose monitor
Change in appetite
Feelings of hunger, desire to eat, fullness and alertness measured using Visual Analogue Scale (VAS)
Secondary Outcome Measures
24 hour energy intake
Food intake over the 24 hours of the study day using a 24 hour food diary entered into dietary analysis software
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05810337
Brief Title
Splenda: Effects on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake
Official Title
The Effects of Splenda (Sucralose) on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake in Humans: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
March 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King's College London
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 investigates the effects of Splenda, an artificial sweetener powder containing sucralose, on post-prandial blood glucose levels, appetite scores and subsequent energy intake.
Detailed Description
Participants are randomly assigned to receive either the placebo drink (4.5g maltodextrin dissolved in 250ml water) or the Splenda drink (4.5g Splenda dissolved in 250ml water) taken alongside a high calorie breakfast.
Blood glucose measurements will be obtained through finger-pricking and appetite will be measured using self-reported visual analogue scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after breakfast. Energy intake will be measured using a 24 hour food diary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetitive Behavior, Glucose Metabolism Disorders
Keywords
Blood glucose, Appetite, Energy intake
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Splenda drink
Arm Type
Experimental
Arm Description
Drink containing 4.5g Splenda dissolved on 250ml water.
Arm Title
Maltodextrin drink
Arm Type
Placebo Comparator
Arm Description
Drink containing 4.5g maltodextrin dissolved on 250ml water.
Intervention Type
Dietary Supplement
Intervention Name(s)
Splenda drink
Intervention Description
4.5g Splenda containing 1% sucralose, 95% maltodextrin, dissolved in 250ml water and consumed with a high carbohydrate breakfast.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin drink
Intervention Description
4.5g maltodextrin dissolved in 250ml water and consumed with a high carbohydrate breakfast.
Intervention Type
Dietary Supplement
Intervention Name(s)
High carbohydrate breakfast
Intervention Description
Meal consisting of 30g cereal with 100ml skimmed milk, 1.5 slices white toast with 12g margarine, providing 386kcal, 61.4g carbohydrate, 10.4g protein and 10.1g fat.
Primary Outcome Measure Information:
Title
Change in blood glucose
Description
Capillary blood glucose from fingerprick and measured using glucose monitor
Time Frame
-5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)
Title
Change in appetite
Description
Feelings of hunger, desire to eat, fullness and alertness measured using Visual Analogue Scale (VAS)
Time Frame
-5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)
Secondary Outcome Measure Information:
Title
24 hour energy intake
Description
Food intake over the 24 hours of the study day using a 24 hour food diary entered into dietary analysis software
Time Frame
0 - 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male and female adults (18-64 years)
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Corpe, Dr.
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE1 9NH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Splenda: Effects on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake
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