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

Sponsor

King's College London (Other)

Overall Status

Completed

CT.gov ID

NCT05810337

Collaborator

(none)

Enrollment

Location

Arms

1.8

Actual Duration (Months)

28.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Appetitive Behavior Glucose Metabolism Disorders	Dietary Supplement: Splenda drink Dietary Supplement: Maltodextrin drink Dietary Supplement: High carbohydrate breakfast	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jan 18, 2023

Actual Primary Completion Date :

Feb 1, 2023

Actual Study Completion Date :

Mar 13, 2023

Arms and Interventions

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: Maltodextrin drink 4.5g 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.

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: Maltodextrin drink

4.5g 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.

Outcome Measures

Primary Outcome Measures

Change in blood glucose [-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
Change in appetite [-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)

Secondary Outcome Measures

24 hour energy intake [0 - 24 hours]
Food intake over the 24 hours of the study day using a 24 hour food diary entered into dietary analysis software

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male and female adults (18-64 years)

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King's College London	London		United Kingdom	SE1 9NH

Sponsors and Collaborators

King's College London

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Christopher Corpe, Nutrition Sciences Lecturer, Principal investigator, King's College London

ClinicalTrials.gov Identifier:

NCT05810337

Other Study ID Numbers:

KCLMScNutr2023

First Posted:

Apr 12, 2023

Last Update Posted:

Apr 12, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr Christopher Corpe, Nutrition Sciences Lecturer, Principal investigator, King's College London

Blood glucose

Appetite

Energy intake

Additional relevant MeSH terms:

Metabolic Diseases

Glucose Metabolism Disorders

Study Results

No Results Posted as of Apr 12, 2023