Appetitive BehaviorNCT05810337
Splenda: Effects on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake
A study testing Splenda drink, Maltodextrin drink and High carbohydrate breakfast 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 Splenda, an artificial sweetener powder containing sucralose, on post-prandial blood glucose levels, appetite scores and subsequent energy intake. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior, Glucose Metabolism Disorders
- What is being tested?
- Splenda drink, Maltodextrin drink and High carbohydrate breakfast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jan 2023to 13 Mar 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female adults (18-64 years)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Splenda (Sucralose) on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake in Humans: a Randomised Controlled Trial
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.
Read the detailed 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.
- Conditions
- Appetitive Behavior, Glucose Metabolism Disorders
- Being tested
- Splenda drink, Maltodextrin drink, High carbohydrate breakfast
- Keywords
- Blood glucose, Appetite, Energy intake
- 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.
Splenda drinkDietary supplement
4.5g Splenda containing 1% sucralose, 95% maltodextrin, dissolved in 250ml water and consumed with a high carbohydrate breakfast.
Maltodextrin drinkDietary supplement
4.5g maltodextrin dissolved in 250ml water and consumed with a high carbohydrate breakfast.
High carbohydrate breakfastDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Splenda drink | Experimental | Drink containing 4.5g Splenda dissolved on 250ml water. Receives: Dietary Supplement: Splenda drink; Dietary Supplement: High carbohydrate breakfast |
| Maltodextrin drink | Placebo comparator | Drink containing 4.5g maltodextrin dissolved on 250ml water. Receives: Dietary Supplement: Maltodextrin drink; Dietary Supplement: High carbohydrate breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose
Capillary blood glucose from fingerprick and measured using glucose monitor
Measured: -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)
Measured: -5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)
Secondary outcomes (1)
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
Measured: 0 - 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start18 Jan 2023
- Primary completion1 Feb 2023
- Study completion13 Mar 2023
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 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
- Christopher Corpe, Dr., Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810337
- Sponsor's protocol ID
- KCLMScNutr2023
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Splenda (Sucralose) on Blood Glucose Concentration, Appetite Scores and Subsequent Energy Intake in Humans: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05810337
- Acronym / sponsor ID
- KCLMScNutr2023
- Conditions
- Appetitive Behavior, Glucose Metabolism Disorders
- Keywords
- Blood glucose, Appetite, Energy intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 12 Apr 2023 (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 Splenda, an artificial sweetener powder containing sucralose, on post-prandial blood glucose levels, appetite scores and subsequent energy intake.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Splenda drink | Experimental | Dietary Supplement: Splenda drink, Dietary Supplement: High carbohydrate breakfastDrink containing 4.5g Splenda dissolved on 250ml water. |
| Maltodextrin drink | Placebo comparator | Dietary Supplement: Maltodextrin drink, Dietary Supplement: High carbohydrate breakfastDrink containing 4.5g maltodextrin dissolved on 250ml water. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and female adults (18-64 years)
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 |
|---|---|---|
| Splenda drink4.5g Splenda containing 1% sucralose, 95% maltodextrin, dissolved in 250ml water and consumed with a high carbohydrate breakfast. | Dietary supplement | Splenda drink |
| Maltodextrin drink4.5g maltodextrin dissolved in 250ml water and consumed with a high carbohydrate breakfast. | Dietary supplement | Maltodextrin drink |
| High carbohydrate breakfastMeal 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. | Dietary supplement | Maltodextrin drink, Splenda drink |
Primary outcome
Change in blood glucose
Time frame: -5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)
Capillary blood glucose from fingerprick and measured using glucose monitor
Change in appetite
Time frame: -5 to 180 minutes (measured from baseline up to 90min every 15min and from 90-180min every 30min)
Feelings of hunger, desire to eat, fullness and alertness measured using Visual Analogue Scale (VAS)
1 secondary outcome
24 hour energy intake
Time frame: 0 - 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Christopher Corpe, Dr. 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 Splenda drink, Maltodextrin drink and High carbohydrate breakfast 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: finished, as of the sponsor's last update on 12 Apr 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: -5 to 180 minutes (measured from baseline up to 90min every 15min and from 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 12 Apr 2023.