Splenda: Effects on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake

March 30, 2023 updated by: Dr Christopher Corpe, King's College London

The Effects of Splenda (Sucralose) on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake in Humans: a Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

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
      • London, United Kingdom, SE1 9NH
        • King's College London

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy male and female adults (18-64 years)

Exclusion Criteria:

-

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Splenda drink
Drink containing 4.5g Splenda dissolved on 250ml water.
Dietary supplement: Splenda drink
4.5g Splenda containing 1% sucralose, 95% maltodextrin, dissolved in 250ml water and consumed with a high carbohydrate breakfast.
Dietary supplement: High carbohydrate breakfast
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.
Placebo Comparator: Maltodextrin drink
Drink containing 4.5g maltodextrin dissolved on 250ml water.
Dietary supplement: High carbohydrate breakfast
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.
Dietary supplement: Maltodextrin drink
4.5g maltodextrin dissolved in 250ml water and consumed with a high carbohydrate breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood glucose
Time Frame: -5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)
Capillary blood glucose from fingerprick and measured using glucose monitor
-5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)
Change in appetite
Time Frame: -5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)
Feelings of hunger, desire to eat, fullness and alertness measured using Visual Analogue Scale (VAS)
-5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hour energy intake
Time Frame: 0 - 24 hours
Food intake over the 24 hours of the study day using a 24 hour food diary entered into dietary analysis software
0 - 24 hours

Collaborators and Investigators

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

Sponsor

King's College London

Investigators

  • Principal Investigator: Christopher Corpe, Dr., King's College London

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)

January 18, 2023

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

March 13, 2023

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCLMScNutr2023

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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