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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05810337
Other study ID # KCLMScNutr2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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: -

Study Design


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
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