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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Appetitive Behavior, Glucose Metabolism Disorders

Intervention / Treatment
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* Dietary Supplement: Splenda drink
* Dietary Supplement: Maltodextrin drink
* Dietary Supplement: High carbohydrate breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female adults (18-64 years) Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood glucose, Appetite, Energy intake