- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03232008
Canderel:Effects on Blood Glucose Concentration and Appetite Scores
The Effects of Canderel (Aspartame and Acesulfame-k Blend) on Blood Glucose Concentration and Appetite Scores in Humans: a Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is separated into two parts: A) investigating the effects of artificial sweeteners in combination with complex carbohydrates; and B) investigating the effects of artificial sweeteners in combination with simple sugars.
A) Participants will be randomly given either the placebo drink (3g of maltodextrin dissolved in 250ml of water) or the Canderel drink (3g of Canderel dissolved in 250ml of water) alongside an isocaloric high carbohydrate breakfast. Blood glucose measurements will be obtained through finger pricking and appetite will be measured using self-reported visual analog scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after breakfast.
B)Participants will be randomly given either the placebo drink (3g of Lyle's Golden syrup and 3g of maltodextrin dissolved in 250ml of water) or the Canderel+sugars drink (3g of Canderel and 3g of Lyle's Golden syrup dissolved in 250ml of water) . Blood glucose measurements will be obtained through finger pricking and appetite will be measured using self-reported visual analog scores rating hunger, desire to eat, fullness and alertness for up to 3 hours after drink
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, SE1 9NH
- King's College London
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male and female adults (18-64)
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experiment A- experimental
3g Canderel in 250ml water
|
1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water
|
|
No Intervention: Experiment A- control
3g of maltodextrin in 250 ml of water
|
|
|
Experimental: Experiment B- experimental
3g Canderel + 35g Lyle's Golden Syrup in 250 ml water
|
Canderel: 1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water Lyle's Golden Syrup: 35 g (27g of glucose and fructose)
|
|
No Intervention: Experiment B- control
3g Lyle's Golden Syrup + 35g of maltodextrin in 250 ml of water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Blood glucose
Time Frame: 0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)
|
Capillary blood obtained from fingerprick and measured using glucose monitor
|
0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)
|
|
Change in Appetite
Time Frame: 0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)
|
Feelings of hunger, desire to eat, fullness and alertness measured using Visual Analog Scale (VAS)
|
0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr. Christopher Corpe, King's College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCLMScNutr2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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