Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
175 participants
INTERVENTIONAL
2021-04-01
2023-11-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Work Package 2 Phase 1 - Beverages Study
NCT04483180
Sweeteners and Sweetness Enhancers: Prolonged Effects on Health, Obesity and Safety
NCT04226911
On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota
NCT02580110
Effects of Sweetness on Neurocognitive Responses, Glycemia and Food Intake
NCT03711084
The Effect of Artificial Sweeteners on Blood Glucose Response
NCT01246492
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cake matrix
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.
Sweetener and sweetness enhancer consumption
Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.
Biscuit matrix
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.
Sweetener and sweetness enhancer consumption
Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.
Yoghurt matrix
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.
Sweetener and sweetness enhancer consumption
Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.
Chocolate matrix
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.
Sweetener and sweetness enhancer consumption
Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.
Cereal matrix
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.
Sweetener and sweetness enhancer consumption
Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.
Universal Eating Monitor study
A sub-group of the yoghurt matrix will be selected for assessment of eating rate and microstructure of feeding using Universal Eating Monitors.
Sweetener and sweetness enhancer consumption
Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.
fMRI study
A sub-group of the chocolate matrix will be selected for assessment of neural activation to images of food using fMRI.
Sweetener and sweetness enhancer consumption
Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sweetener and sweetness enhancer consumption
Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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
Exclusion Criteria
* 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.
* 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).
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Navarra
OTHER
University of Liverpool
OTHER
Københavns Universitet
OTHER
Centre de Recherche en Nutrition Humaine Rhone-Alpe
OTHER
University of Surrey
OTHER
Bioatriki Healthcare Group
UNKNOWN
University of Leeds
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Graham Finlayson
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Copenhagen
Copenhagen, , Denmark
CRNH-RA
Lyon, , France
University of Navarra
Pamplona, , Spain
University of Leeds
Leeds, West Yorkshire, United Kingdom
University of Liverpool
Liverpool, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
774293-WP2-P2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.