Eating BehaviorSWEET-WP2-P2NCT04633681
Impact of Sweeteners on Behaviour, Physiology & Health
A study testing Sweetener and sweetness enhancer consumption in people with Eating Behavior, run by University of Leeds at 5 sites in 4 countries.
Trial summary
This study aims to evaluate the acute (1-day) and repeated (2-week) effects of combinations of Sweeteners \& Sweetness Enhancer blends on metabolic, sensory, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preferences and health. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Sweetener and sweetness enhancer consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Apr 2021to 20 Nov 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 25 to 35 kg/m2
- Use of contraceptive methods or not planning to become pregnant for the duration of the study (women only)
- Regular consumption of sugar-containing foods and willing to consume sugar and artificially-sweetened food products.
- Liking of the intervention foods defined by a response of Yes for the product during the pre-screening interview and a score of 40% or above on the Liking Visual Analogue Scale for the sucrose-sweetened control product.
- Able to participate on the Clinical Investigation Days during normal working hours.
- Healthy as determined from the self-reported medical history or when a clinical condition exists, when this is considered to be irrelevant (i.e. not influencing study outcomes) for the study by the study medical doctor.
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- Consuming breakfast regularly (at least 5 days per week).
- Able to understand and be willing to sign the informed consent form, and to follow all the study procedures and requirements.
- Capacity to store at-home intervention quantity of intervention product
Who cannot join
- Blood donation < 3 month prior to study or for full duration of the study.
- Food allergy, intolerance, restriction or avoidance of any of the study foods (e.g. veganism) or history of anaphylactic reaction to any food.
- Likelihood for disordered eating defined as a score ≥20 on the Eating Attitudes Test.
- Currently dieting to lose weight.
- Having lost or gained >4.5 kg in the last 3 months.
- Smoking or having quit <3 months prior to study.
Show all 30Show fewer
- Habitually consuming >14 units/week of alcohol in women or >21 units/week in men in the last 3 months.
- Performing >10 h of intense physical activity per week in the last 3 months.
- Night or late shift work (ending later than 11 pm on a permanent basis). Rotational shift work allowed if can attend on days that do not follow a late/night shift.
- Self-reported use of drugs of abuse within the previous 12 months.
- Pregnancy, lactation (women only)
- Persons who do not have access to either (mobile) phone or internet (this is necessary when being contacted by the study personnel during the study).
- Insufficient communication in the national language.
- Proven or suspected inability, physically or mentally, to comply with the procedures required by the study protocol as evaluated by the daily study manager, site-PI, PI or clinical responsible. This includes volunteers for which insufficient collaboration may be foreseen.
- Subject's general condition contraindicates continuing in the study as evaluated by the daily study manager, site-PI, PI or responsible clinician.
- Simultaneous participation in other relevant clinical intervention studies.
- Previous university or college training related to eating behaviour research.
- Self-reported eating disorders.
- Diagnosed anaemia.
- Diagnosed diabetes mellitus.
- Abnormal G.I. function or structure such as malformation, angiodysplasia, active peptic ulcer.
- Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption.
- History of G.I. surgery with permanent effect (i.e. surgical treatment of obesity).
- Medical history of Cardiovascular Disease (e.g. current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease).
- Significant liver disease, e.g. cirrhosis (fatty liver disease allowed).
- Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed).
- Thyroid diseases, except those on Levothyroxine treatment of hypothyroidism if the person has been on a stable dose for at least 3 months.
- Psychiatric illness (e.g. major depression, bipolar disorders).
- Use currently or within the previous 3 months of prescription or over the counter medication that has the potential of affecting appetite, satiety or body weight incl. food supplements. Except: low dose antidepressants if they, in the judgement of the daily study manager, site-PI, PI or clinical responsible, do not affect weight or following the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the person has been on a stable dose for at least 3 months.
- Cholesterol lowering medication, if the dose has changed during the last 3 months (i.e. the medication is allowed if the participant has been on a stable dose for at least 3 months).
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United Kingdom2 sites
University of Leeds
Leeds, West Yorkshire, LS2 9JT
University of Liverpool
Liverpool
About this study
Official title: Acute and Repeated Impact of Sweeteners and Sweetness Enhancers on Food Behaviour, Physiology & Health (SWEET Work Package 2 Phase 2)
This study aims to evaluate the acute (1-day) and repeated (2-week) effects of combinations of Sweeteners \& Sweetness Enhancer blends on metabolic, sensory, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preferences and health.
Read the detailed description
This protocol has the overall objective to evaluate the acute (short-term, 1 day) and repeated (medium-term, 2 week) effects of combinations of sweeteners and sweetness enhancers (S\&SEs) on metabolic, sensory, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preference and health, and to explore mechanistic processes, genetic background, safety issues and consumer perspectives.
There are 5 products being tested in 3 different formulations (sucrose-sweetened control vs 2 reformulated with S\&SE). Each product will be tested at 2 intervention sites in double-blind cross-over trials with 48 subjects (24 per site) tested per product. Therefore a total of 240 subjects will take part across the 5 intervention sites (Navarra, Leeds, Liverpool, Copenhagen, Lyon).
Using identical procedures each trial will consist of 2 Clinical Investigation Days (CIDs) scheduled 12 days apart for each of the 3 product formulations. A 2-week wash-out period will be given between formulations.
The total duration of WP2 Phase 2 is 12 months, including a 5-month duration for each cross-over trial.
- Conditions
- Eating Behavior
- Being tested
- Sweetener and sweetness enhancer consumption
- Keywords
- appetite, food preferences, sweeteners, sweetness enhancers
- Medical subject headings
- Feeding Behavior, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweetener and sweetness enhancer consumptionDietary supplement
Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.
| Study group | Role | What they receive |
|---|---|---|
| Cake matrix | Experimental | 3 phases of 2-week daily consumption of cake product containing 1) sucrose, 2) Neotame 1, 3) Stevia Reb M. Randomised cross-over with 2-week wash-out between phases. Receives: Dietary Supplement: Sweetener and sweetness enhancer consumption |
| Biscuit matrix | Experimental | 3 phases of 2-week daily consumption of biscuit product containing 1) sucrose, 2) Neotame 1, 3) Stevia Reb M. Randomised cross-over with 2-week wash-out between phases. Receives: Dietary Supplement: Sweetener and sweetness enhancer consumption |
| Yoghurt matrix | Experimental | 3 phases of 2-week daily consumption of yoghurt product containing 1) sucrose, 2) sweetener blend 1, 3) sweetener blend 2. Randomised cross-over with 2-week wash-out between phases. Receives: Dietary Supplement: Sweetener and sweetness enhancer consumption |
| Chocolate matrix | Experimental | 3 phases of 2-week daily consumption of chocolate product containing 1) sucrose, 2) sweetener blend 1, 3) sweetener blend 2. Randomised cross-over with 2-week wash-out between phases. Receives: Dietary Supplement: Sweetener and sweetness enhancer consumption |
| Cereal matrix | Experimental | 3 phases of 2-week daily consumption of cereal product containing 1) sucrose, 2) sweetener blend 1, 3) sweetener blend 2. Randomised cross-over with 2-week wash-out between phases. Receives: Dietary Supplement: Sweetener and sweetness enhancer consumption |
| Universal Eating Monitor study | Experimental | A sub-group of the yoghurt matrix will be selected for assessment of eating rate and microstructure of feeding using Universal Eating Monitors. Receives: Dietary Supplement: Sweetener and sweetness enhancer consumption |
| fMRI study | Experimental | A sub-group of the chocolate matrix will be selected for assessment of neural activation to images of food using fMRI. Receives: Dietary Supplement: Sweetener and sweetness enhancer consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Appetite Sensations Incremental Area Under the Curve
Incremental area under the curve (iAUC) for composite appetite sensations in response to each product.
During each of the Clinical Investigation Days iAUC composite appetite will be measured 180 minutes post intake.
The following sensations of appetite will be used in the composite measure:
- hunger
- fullness
- desire to eat
- prospective consumption
Minimum value 0 Maximum value 100 Higher scores mean worse outcome
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Secondary outcomes (12)
Leeds Food Preference Questionnaire (LFPQ) Explicit Liking
Change in explicit liking for foods at 15 min post intake Minimum value -100 Maximum value 100 Higher scores mean worse outcome
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Leeds Food Preference Questionnaire (LFPQ) Implicit Wanting
Change in implicit wanting for foods at 15 min post intake Minimum value -100 Maximum value 100 Higher scores mean worse outcome
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Leeds Food Preference Questionnaire (LFPQ) Relative preference
Change in relative preference for foods at 15 min post intake Minimum value -48 Maximum value 48 Higher scores mean worse outcome
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Leeds Food Preference Questionnaire (LFPQ) Explicit wanting
Change in explicit wanting for foods at 15 min post intake Minimum value -100 Maximum value 100 Higher scores mean worse outcome
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Control of Eating Questionnaire (CoEQ): Craving Control
Craving Control examined in a fasted state. Minimum value 0 Maximum value 100 Higher scores mean better outcome
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Control of Eating Questionnaire (CoEQ): Craving for Sweet
Craving for Sweet examined in a fasted state. Minimum value 0 Maximum value 100 Higher scores mean worse outcome
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Control of Eating Questionnaire (CoEQ): Craving for Savoury
Craving for Savoury examined in a fasted state. Minimum value 0 Maximum value 100 Higher scores mean worse outcome
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Control of Eating Questionnaire (CoEQ): Positive Mood
Positive Mood examined in a fasted state. Minimum value 0 Maximum value 100 Higher scores mean better outcome
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Blood Glucose Incremental Area Under the Curve
Incremental area under the curve for blood glucose concentrations in response to each product (120 min post intake).
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Blood Insulin Incremental Area Under the Curve
Incremental area under the curve for blood insulin concentrations in response to each product (120 min post intake).
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Cephalic and intestinal satiety biomarkers: Glucagon-like peptide-1 (GLP-1)
Incremental area under the curve for blood GLP-1 concentrations in response to each product (120 min post intake).
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Cephalic and intestinal satiety biomarkers: Ghrelin
Incremental area under the curve for blood Ghrelin concentrations in response to each product (120 min post intake).
Measured: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Apr 2021
- Primary completion29 Sep 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Double-blind, within-subjects, cross-over trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarra, University of Liverpool, Københavns Universitet, Centre de Recherche en Nutrition Humaine Rhone-Alpe, University of Surrey, Bioatriki Healthcare Group
- Responsible party
- Principal investigator, Dr Graham Finlayson, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633681
- Sponsor's protocol ID
- 774293-WP2-P2
- Acronym
- SWEET-WP2-P2
- Status last verified
- Aug 2024
- First submitted
- 30 Oct 2020
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gibbons C, O'Hara B, O'Connor D, Hardman C, Wilton M, Harrold JA, Almiron-Roig E, Navas-Carretero S, Hodgkins CE, Nazare JA, Alligier M, Martinez JA, Scott C, Kjolbaek L, Normand M, Rannou C, Blaak EE, Feskens E, Moshoyiannis H, Raben A, Halford JCG, Beaulieu K, Finlayson G. Acute and repeated impact of sweeteners and sweetness enhancers in solid and semi-solid foods on appetite: protocol for a multicentre, cross-over, RCT in people with overweight/obesity - the SWEET Project. BMJ Open. 2022 Dec 23;12(12):e063903. doi: 10.1136/bmjopen-2022-063903.
PubMed 36564114
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Repeated Impact of Sweeteners and Sweetness Enhancers on Food Behaviour, Physiology & Health (SWEET Work Package 2 Phase 2)
- ClinicalTrials.gov ID
- NCT04633681
- Acronym / sponsor ID
- SWEET-WP2-P2 / 774293-WP2-P2
- Conditions
- Eating Behavior
- Keywords
- appetite, food preferences, sweeteners, sweetness enhancers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- University of Navarra, University of Liverpool, Københavns Universitet, Centre de Recherche en Nutrition Humaine Rhone-Alpe, University of Surrey, Bioatriki Healthcare Group
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 18 Nov 2020 (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 aims to evaluate the acute (1-day) and repeated (2-week) effects of combinations of Sweeteners \& Sweetness Enhancer blends on metabolic, sensory, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preferences and health.
Detailed description
This protocol has the overall objective to evaluate the acute (short-term, 1 day) and repeated (medium-term, 2 week) effects of combinations of sweeteners and sweetness enhancers (S\&SEs) on metabolic, sensory, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preference and health, and to explore mechanistic processes, genetic background, safety issues and consumer perspectives.
There are 5 products being tested in 3 different formulations (sucrose-sweetened control vs 2 reformulated with S\&SE). Each product will be tested at 2 intervention sites in double-blind cross-over trials with 48 subjects (24 per site) tested per product. Therefore a total of 240 subjects will take part across the 5 intervention sites (Navarra, Leeds, Liverpool, Copenhagen, Lyon).
Using identical procedures each trial will consist of 2 Clinical Investigation Days (CIDs) scheduled 12 days apart for each of the 3 product formulations. A 2-week wash-out period will be given between formulations.
The total duration of WP2 Phase 2 is 12 months, including a 5-month duration for each cross-over trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Double-blind, within-subjects, cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Cake matrix | Experimental | Dietary Supplement: Sweetener and sweetness enhancer consumption3 phases of 2-week daily consumption of cake product containing 1) sucrose, 2) Neotame 1, 3) Stevia Reb M. Randomised cross-over with 2-week wash-out between phases. |
| Biscuit matrix | Experimental | Dietary Supplement: Sweetener and sweetness enhancer consumption3 phases of 2-week daily consumption of biscuit product containing 1) sucrose, 2) Neotame 1, 3) Stevia Reb M. Randomised cross-over with 2-week wash-out between phases. |
| Yoghurt matrix | Experimental | Dietary Supplement: Sweetener and sweetness enhancer consumption3 phases of 2-week daily consumption of yoghurt product containing 1) sucrose, 2) sweetener blend 1, 3) sweetener blend 2. Randomised cross-over with 2-week wash-out between phases. |
| Chocolate matrix | Experimental | Dietary Supplement: Sweetener and sweetness enhancer consumption3 phases of 2-week daily consumption of chocolate product containing 1) sucrose, 2) sweetener blend 1, 3) sweetener blend 2. Randomised cross-over with 2-week wash-out between phases. |
| Cereal matrix | Experimental | Dietary Supplement: Sweetener and sweetness enhancer consumption3 phases of 2-week daily consumption of cereal product containing 1) sucrose, 2) sweetener blend 1, 3) sweetener blend 2. Randomised cross-over with 2-week wash-out between phases. |
| Universal Eating Monitor study | Experimental | Dietary Supplement: Sweetener and sweetness enhancer consumptionA sub-group of the yoghurt matrix will be selected for assessment of eating rate and microstructure of feeding using Universal Eating Monitors. |
| fMRI study | Experimental | Dietary Supplement: Sweetener and sweetness enhancer consumptionA sub-group of the chocolate matrix will be selected for assessment of neural activation to images of food using fMRI. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- BMI: 25 to 35 kg/m2
- Use of contraceptive methods or not planning to become pregnant for the duration of the study (women only)
- Regular consumption of sugar-containing foods and willing to consume sugar and artificially-sweetened food products.
- Liking of the intervention foods defined by a response of Yes for the product during the pre-screening interview and a score of 40% or above on the Liking Visual Analogue Scale for the sucrose-sweetened control product.
- Able to participate on the Clinical Investigation Days during normal working hours.
Key exclusion criteria (30 listed)
- Blood donation < 3 month prior to study or for full duration of the study.
- Food allergy, intolerance, restriction or avoidance of any of the study foods (e.g. veganism) or history of anaphylactic reaction to any food.
- Likelihood for disordered eating defined as a score ≥20 on the Eating Attitudes Test.
- Currently dieting to lose weight.
- Having lost or gained >4.5 kg in the last 3 months.
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 |
|---|---|---|
| Sweetener and sweetness enhancer consumptionTwo-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product. | Dietary supplement | Biscuit matrix, Cake matrix, Cereal matrix, Chocolate matrix, Universal Eating Monitor study, Yoghurt matrix, fMRI study |
Primary outcome
Composite Appetite Sensations Incremental Area Under the Curve
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Incremental area under the curve (iAUC) for composite appetite sensations in response to each product. During each of the Clinical Investigation Days iAUC composite appetite will be measured 180 minutes post intake. The following sensations of appetite will be used in the composite measure: * hunger * fullness * desire to eat * prospective consumption Minimum value 0 Maximum value 100 Higher scores mean worse outcome
12 secondary outcomes
Leeds Food Preference Questionnaire (LFPQ) Explicit Liking
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Leeds Food Preference Questionnaire (LFPQ) Implicit Wanting
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Leeds Food Preference Questionnaire (LFPQ) Relative preference
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Leeds Food Preference Questionnaire (LFPQ) Explicit wanting
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Control of Eating Questionnaire (CoEQ): Craving Control
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Control of Eating Questionnaire (CoEQ): Craving for Sweet
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Control of Eating Questionnaire (CoEQ): Craving for Savoury
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Control of Eating Questionnaire (CoEQ): Positive Mood
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Blood Glucose Incremental Area Under the Curve
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Blood Insulin Incremental Area Under the Curve
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Cephalic and intestinal satiety biomarkers: Glucagon-like peptide-1 (GLP-1)
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Cephalic and intestinal satiety biomarkers: Ghrelin
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
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 Aug 2024.
- Derived from this study: PubMed 36564114Gibbons C, O'Hara B, O'Connor D, Hardman C, Wilton M, Harrold JA, Almiron-Roig E, Navas-Carretero S, Hodgkins CE, Nazare JA, Alligier M, Martinez JA, Scott C, Kjolbaek L, Normand M, Rannou C, Blaak EE, Feskens E, Moshoyiannis H, Raben A, Halford JCG, Beaulieu K, Finlayson G. Acute and repeated impact of sweeteners and sweetness enhancers in solid and semi-solid foods on appetite: protocol for a multicentre, cross-over, RCT in people with overweight/obesity - the SWEET Project. BMJ Open. 2022 Dec 23;12(12):e063903. doi: 10.1136/bmjopen-2022-063903.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sweetener and sweetness enhancer consumption in people with Eating Behavior, run by University of Leeds at 5 sites in 4 countries.
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 9 inclusion and 30 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Denmark, France, Spain. 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?
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?
Composite Appetite Sensations Incremental Area Under the Curve (time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633681, which also lists 1 linked publication.
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 Aug 2024.