Back to resultsCanderel:Effects on Blood Glucose Concentration and Appetite Scores
Primary Purpose
Appetitive Behavior, Glucose Metabolism Disorders
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Canderel drink
Canderel+Lyle's Golden Syrup drink
Sponsored by
About this trial
This is an interventional basic science trial for Appetitive Behavior focused on measuring Blood glucose, Appetite
Eligibility Criteria
Inclusion Criteria:
- Healthy male and female adults (18-64)
Exclusion Criteria:
-
Sites / Locations
- King's College London
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
Experiment A- experimental
Experiment A- control
Experiment B- experimental
Experiment B- control
Arm Description
3g Canderel in 250ml water
3g of maltodextrin in 250 ml of water
3g Canderel + 35g Lyle's Golden Syrup in 250 ml water
3g Lyle's Golden Syrup + 35g of maltodextrin in 250 ml of water
Outcomes
Primary Outcome Measures
Change in Blood glucose
Capillary blood obtained from fingerprick and measured using glucose monitor
Change in Appetite
Feelings of hunger, desire to eat, fullness and alertness measured using Visual Analog Scale (VAS)
Secondary Outcome Measures
Full Information
NCT ID
NCT03232008
First Posted
June 19, 2017
Last Updated
September 21, 2020
Sponsor
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT03232008
Brief Title
Canderel:Effects on Blood Glucose Concentration and Appetite Scores
Official Title
The Effects of Canderel (Aspartame and Acesulfame-k Blend) on Blood Glucose Concentration and Appetite Scores in Humans: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
March 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study investigates the effects of Canderel, an aspartame and acesulfame-k blend artificial sweetener powder, on post-postprandial blood glucose levels and appetite scores.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetitive Behavior, Glucose Metabolism Disorders
Keywords
Blood glucose, Appetite
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experiment A- experimental
Arm Type
Experimental
Arm Description
3g Canderel in 250ml water
Arm Title
Experiment A- control
Arm Type
No Intervention
Arm Description
3g of maltodextrin in 250 ml of water
Arm Title
Experiment B- experimental
Arm Type
Experimental
Arm Description
3g Canderel + 35g Lyle's Golden Syrup in 250 ml water
Arm Title
Experiment B- control
Arm Type
No Intervention
Arm Description
3g Lyle's Golden Syrup + 35g of maltodextrin in 250 ml of water
Intervention Type
Dietary Supplement
Intervention Name(s)
Canderel drink
Intervention Description
1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water
Intervention Type
Dietary Supplement
Intervention Name(s)
Canderel+Lyle's Golden Syrup drink
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in Blood glucose
Description
Capillary blood obtained from fingerprick and measured using glucose monitor
Time Frame
0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)
Title
Change in Appetite
Description
Feelings of hunger, desire to eat, fullness and alertness measured using Visual Analog Scale (VAS)
Time Frame
0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy male and female adults (18-64)
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Christopher Corpe
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE1 9NH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Canderel:Effects on Blood Glucose Concentration and Appetite Scores
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