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Completed

NCT Number: NCT05810337

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

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.

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Key information

Conditions

Appetitive Behavior Behavior Behavior, Animal Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

London, SE1 9NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Splenda drink

Dietary Supplement

4.5g Splenda containing 1% sucralose, 95% maltodextrin, dissolved in 250ml water and consumed with a high carbohydrate breakfast.

Maltodextrin Drink

Dietary Supplement

4.5g maltodextrin dissolved in 250ml water and consumed with a high carbohydrate breakfast.

High carbohydrate breakfast

Dietary Supplement

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 outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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