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

Glucose Metabolism Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05810337
• Other study ID #: KCLMScNutr2023
• Status: Completed
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: March 13, 2023

Study information

• Verified date: March 2023
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 13, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Appetitive Behavior
• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Dietary Supplement:
• Splenda drink
4.5g Splenda containing 1% sucralose, 95% maltodextrin, dissolved in 250ml water and consumed with a high carbohydrate breakfast.
• Maltodextrin drink
4.5g maltodextrin dissolved in 250ml water and consumed with a high carbohydrate breakfast.
• 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.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood glucose	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)
Primary	Change in appetite	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	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	0 - 24 hours