Appetitive BehaviorNCT03232008
Canderel:Effects on Blood Glucose Concentration and Appetite Scores
A study testing Canderel drink and Canderel+Lyle's Golden Syrup drink in people with Appetitive Behavior and Glucose Metabolism Disorders, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Appetitive Behavior, Glucose Metabolism Disorders
- What is being tested?
- Canderel drink and Canderel+Lyle's Golden Syrup drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2015to 28 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy male and female adults (18-64)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Canderel (Aspartame and Acesulfame-k Blend) on Blood Glucose Concentration and Appetite Scores in Humans: a Randomised Controlled Trial
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.
Read the 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.
- 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
- Conditions
- Appetitive Behavior, Glucose Metabolism Disorders
- Being tested
- Canderel drink, Canderel+Lyle's Golden Syrup drink
- Keywords
- Blood glucose, Appetite
- Medical subject headings
- Appetitive Behavior, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canderel drinkDietary supplement
1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water
Canderel+Lyle's Golden Syrup drinkDietary supplement
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)
| Study group | Role | What they receive |
|---|---|---|
| Experiment A- experimental | Experimental | 3g Canderel in 250ml water Receives: Dietary Supplement: Canderel drink |
| Experiment A- control | No intervention | 3g of maltodextrin in 250 ml of water |
| Experiment B- experimental | Experimental | 3g Canderel + 35g Lyle's Golden Syrup in 250 ml water Receives: Dietary Supplement: Canderel+Lyle's Golden Syrup drink |
| Experiment B- control | No intervention | 3g Lyle's Golden Syrup + 35g of maltodextrin in 250 ml of water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood glucose
Capillary blood obtained from fingerprick and measured using glucose monitor
Measured: 0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)
Change in Appetite
Feelings of hunger, desire to eat, fullness and alertness measured using Visual Analog Scale (VAS)
Measured: 0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start1 Sep 2015
- Primary completion28 Feb 2019
- Study completion28 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Christopher Corpe, King's College London
- Investigators
- Dr. Christopher Corpe, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232008
- Sponsor's protocol ID
- KCLMScNutr2017
- Status last verified
- Sep 2020
- First submitted
- 19 Jun 2017
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Canderel (Aspartame and Acesulfame-k Blend) on Blood Glucose Concentration and Appetite Scores in Humans: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03232008
- Acronym / sponsor ID
- KCLMScNutr2017
- Conditions
- Appetitive Behavior, Glucose Metabolism Disorders
- Keywords
- Blood glucose, Appetite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Mar 2021 (estimated)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experiment A- experimental | Experimental | Dietary Supplement: Canderel drink3g Canderel in 250ml water |
| Experiment A- control | No intervention | –3g of maltodextrin in 250 ml of water |
| Experiment B- experimental | Experimental | Dietary Supplement: Canderel+Lyle's Golden Syrup drink3g Canderel + 35g Lyle's Golden Syrup in 250 ml water |
| Experiment B- control | No intervention | –3g Lyle's Golden Syrup + 35g of maltodextrin in 250 ml of water |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and female adults (18-64)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canderel drink1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water | Dietary supplement | Experiment A- experimental |
| Canderel+Lyle's Golden Syrup drinkCanderel: 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) | Dietary supplement | Experiment B- experimental |
Primary outcome
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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Appetitive Behavior
Active, not recruitingObservational study
Appetitive Conditioning in Anorexia Nervosa
Anorexia Nervosa
Recruiting
Behavioral Approach for Latinas Addressing Nutrition, Cravings, and Eating Patterns to Prevent Type 2 Diabetes
Prediabetes, Obesity (Body Mass Index >30 kg/m2)
Recruiting
Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans
Appetitive Behavior, Obesity
Recruiting
Exercise, Brain Activity, and Weight Maintenance
Obesity, Weight Gain
RecruitingPhase 4
Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity
Obesity, Weight Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Christopher Corpe principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canderel drink and Canderel+Lyle's Golden Syrup drink in people with Appetitive Behavior and Glucose Metabolism Disorders, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood glucose (time frame: 0-180min (Measured from baseline to 90min every 15min; 90-180min every 30min)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.