Glycemic IndexSWEET-WP2-P1NCT04483180
Work Package 2 Phase 1 - Beverages Study
A study testing Comparison of sweetener blends in liquid form (cross-over study) in people with Glycemic Index and Overweight and Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 3 sites in 3 countries.
Trial summary
Within the SWEET project (EU funded), in Work Package 2 there are two phases, this study refers to Phase 1 of the SWEET WP2 project, which will be a coordinated trial across 3 intervention centres, University of Navarra (UNAV), University of Liverpool (ULIV) and University of Copenhagen (UCPH). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index, Overweight and Obesity
- What is being tested?
- Comparison of sweetener blends in liquid form (cross-over study)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 14 Aug 2020to 30 Jun 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-60 years.
- BMI: 25 to 35 kg/m2.
- For women: Use of contraceptive methods or not planning to become pregnant for the duration of the study.
- Regular consumption of sugar-containing foods and willing to consume artificially-sweetened beverages (a score of ≥ 5 on the short sFFQ Part 1a and answer Yes to all questions in Part 2).
- Able to participate on the visit days/CIDs 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).
- Liking of the study foods defined by a response of Yes for each of the breakfast foods during the pre-screening interview and a score of 40 % or above on the Liking VAS for the control beverage.
- Able to understand and be willing to sign the informed consent form, and to follow all the study procedures and requirements.
Who cannot join
- Blood donation < 3 month prior to study.
- Deficient nutrition or hydration status as identified from the pre-screening/screening session (i.e. absence of disease including anaemia, BMI >18 kg/m2, or other criteria as determined by the study doctor).
- 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 of 20 or more on the EAT-26 test.
- Currently dieting to lose weight or having been on weight cycles (i.e. repeatedly lost and re-gained weight) in the last 3 months.
- Smoking.
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- Binge drinking i.e. consuming >14 units of alcohol per week in women or >21 units/week in men less than 4 days apart.
- Performing >10 h of intense physical activity per week.
- Continuous 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.
- For women: Pregnancy, lactation.
- 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 clinical responsible.
- Simultaneous participation in other relevant clinical intervention studies.
- Previous university or college training related to eating behaviour research.
- Medical conditions as known by the person:
- Self-reported eating disorders.
- Diagnosed anaemia.
- Diagnosed diabetes mellitus.
- Abnormal gastro-intestinal (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 cardio-vascular 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).
- Medication:
- 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
3 sites in 3 countries.
3 sites in 3 countries
Spain1 site
Centre for Nutrition Research, University of Navarra
Pamplona, Navarre, 31008
About this study
Official title: Sweeteners and Sweetness Enhancers: Short-term Impact on Food Behaviour, Physiology & Health (Phase 1)
Within the SWEET project (EU funded), in Work Package 2 there are two phases, this study refers to Phase 1 of the SWEET WP2 project, which will be a coordinated trial across 3 intervention centres, University of Navarra (UNAV), University of Liverpool (ULIV) and University of Copenhagen (UCPH). It will involve an acute intervention in 120 individuals to explore initial acceptance, safety and post-prandial effects of 3 S\&SE blends delivered in beverage format.
The main endpoints of the SWEET WP2 Phase 1 study will be glycaemic and lipaemic responses; eating behavior (subjective appetite, food preference, cravings, reward), and health effects (rebound hunger, G.I. side effects and metabolic effects). This phase will be exploratory and will not involve any specific primary hypotheses.
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 and neuro-behavioural processes involved in satiety, consumer preference and health, and to explore mechanistic processes, genetic background, safety issues and consumer perspectives.
There are 4 products being tested in 4 different formulations (sucrose-sweetened beverage control vs. 3 reformulated beverages with S\&SE). Each product will be tested at 3 intervention sites in double-blind cross-over trials with 40 subjects per site, tested per product. Therefore a total of 120 subjects will take part across the 3 intervention sites (UNAV, ULIV, UCPH).
Using identical procedures each trial will consist of 4 Clinical Investigation Days (CIDs) scheduled 7-11 days apart for each of the 3 product formulations.
The total duration of WP2 Phase 2 per site is 6 months, including a minimum of 22 days and a maximum of 34 days for each participant.
- Conditions
- Glycemic Index, Overweight and Obesity
- Being tested
- Comparison of sweetener blends in liquid form (cross-over study)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of sweetener blends in liquid form (cross-over study)Other
The aim is to compare the effects of different sweetener blends on glycemia, subjective appetite parameters and safety parameters when consumed in a beverage as part of a breakfast
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Beverage containing a sucrose solution. Same aspect and flavor than the experimental beverages. About 1/4 of participants will start with this beverage first. Receives: Other: Comparison of sweetener blends in liquid form (cross-over study) |
| Sucralose / acesulfame K | Experimental | Beverage containing a blend of sweeteners based on sucralose and acesulfame K. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first. Receives: Other: Comparison of sweetener blends in liquid form (cross-over study) |
| Stevia rebaudioside A / thaumatin | Experimental | Beverage containing a blend of sweeteners based on stevia rebaudioside A and thaumatin. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first. Receives: Other: Comparison of sweetener blends in liquid form (cross-over study) |
| Mogroside V / stevia rebaudioside M | Experimental | Beverage containing a blend of sweeteners based on mogroside V and stevia rebaudioside M. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first. Receives: Other: Comparison of sweetener blends in liquid form (cross-over study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose area under the curve (AUC)
Area Under the Curve (AUC) for blood glucose (120 min post-intake)
Measured: Clinical Investigation Day 1, 2, 3, 4
Blood Insulin AUC
Area Under the Curve for blood Insulin (120 min post-intake)
Measured: Clinical Investigation Day 1, 2, 3, 4
Hunger iAUC
Incremental Area Under the Curve for hunger (120 min post-intake)
Measured: Clinical Investigation Day 1, 2, 3, 4
Fasting Blood glucose
Fasting blood glucose
Measured: Clinical Investigation Day 1, 2, 3, 4
30 min Blood glucose
Blood glucose at 30 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
60 min Blood glucose
Blood glucose at 60 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
90 min Blood glucose
Blood glucose at 90 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
120 min Blood glucose
Blood glucose at 120 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
Fasting Blood insulin
Fasting blood insulin
Measured: Clinical Investigation Day 1, 2, 3, 4
30 min Blood insulin
Blood insulin at 30 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
60 min Blood insulin
Blood insulin at 60 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
90 min Blood insulin
Blood insulin at 90 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
120 min Blood insulin
Blood insulin at 120 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
Fasting Hunger (VAS registered)
Fasting subjective appetite questionnaire. Visual Analogue Scale
Measured: Clinical Investigation Day 1, 2, 3, 4
5 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 5 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
15 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 15 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
30 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 30 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
45 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 45 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
60 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 60 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
120 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 120 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
180 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 180 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
Secondary outcomes (37)
Fasting Blood cholesterol
Fasting blood cholesterol
Measured: Clinical Investigation Day 1, 2, 3, 4
30 min Blood cholesterol
Blood cholesterol at 30 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
60 min Blood cholesterol
Blood cholesterol at 60 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
90 min Blood cholesterol
Blood cholesterol at 90 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
120 min Blood cholesterol
Blood cholesterol at 120 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
Fasting Triglycerides
Fasting triglycerides in serum
Measured: Clinical Investigation Day 1, 2, 3, 4
30 min Triglycerides
Triglycerides in serum at 30 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
60 min Triglycerides
Triglycerides in serum at 60 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
90 min Triglycerides
Triglycerides in serum at 90 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
120 min Triglycerides
Triglycerides in serum at 120 in post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
Fasting HDL-cholesterol
Fasting HDL-cholesterol in serum
Measured: Clinical Investigation Day 1, 2, 3, 4
30 min HDL-cholesterol
HDL-cholesterol in serum at 30 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
60 min HDL-cholesterol
HDL-cholesterol in serum at 60 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
90 min HDL-cholesterol
HDL-cholesterol in serum at 90 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
120 min HDL-cholesterol
HDL-cholesterol in serum at 120 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
Fasting LDL-cholesterol
Fasting LDL-cholesterol in serum
Measured: Clinical Investigation Day 1, 2, 3, 4
30 min LDL-cholesterol
LDL-cholesterol in serum at 30 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
60 min LDL-cholesterol
LDL-cholesterol in serum at 60 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
90 min LDL-cholesterol
LDL-cholesterol in serum at 90 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
120 min LDL-cholesterol
LDL-cholesterol in serum at 120 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
Fasting Alanine aminotransferase (ALT)
Fasting liver function marker ALT
Measured: Clinical Investigation Day 1, 2, 3, 4
120 min Alanine aminotransferase (ALT)
Liver function marker ALT at 120 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
Fasting Aspartate aminotransferase (AST)
Fasting liver function marker AST
Measured: Clinical Investigation Day 1, 2, 3, 4
120 min Aspartate aminotransferase (AST)
Liver function marker AST at 120 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
Weight
Anthropometry marker
Measured: Visit 0 (screening), Clinical Investigation Day 4
Height
Anthropometry marker
Measured: Visit 0 (screening)
Body Mass Index (BMI)
Anthropometry marker
Measured: Visit 0 (screening), Clinical Investigation Day 4
Waist Circumference (WC)
Anthropometry marker
Measured: Visit 0 (screening)
Hip Circumference (HC)
Anthropometry marker
Measured: Visit 0 (screening)
Waist-to-hip ratio (WHR)
Anthropometry marker
Measured: Visit 0 (screening)
Leeds Food Preference Questionnaire (LFPQ)
Change in food preference and food reward at 15-20 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
Liking (VAS registered)
Liking and explicit wanting of the beverage at 5 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
Fasting FG21
Fasting FG21 concentration in serum
Measured: Clinical Investigation Day 1, 2, 3, 4
30 min FG21
FG21 concentration in serum at 30 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
60 min FG21
FG21 concentration in serum at 60 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
90 min FG21
FG21 concentration in serum at 90 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
120 min FG21
FG21 concentration in serum at 120 min post-intake
Measured: Clinical Investigation Day 1, 2, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start14 Aug 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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 Glycemic IndexStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multi-centre crossover study with 4 conditions using balanced block randomisation. The three centres will follow different randomisation sequences but will all test the same 4 conditions (University of Navarra, University of Copenhagen, University of Liverpool).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, University of Copenhagen, University of Liverpool, University of Surrey, Bioiatriki HEALTHCARE GROUP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483180
- Sponsor's protocol ID
- 774293-WP2-P1
- Acronym
- SWEET-WP2-P1
- Status last verified
- Jun 2020
- First submitted
- 8 Jul 2020
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Almiron-Roig E, Navas-Carretero S, Castelnuovo G, Kjolbaek L, Romo-Hualde A, Normand M, Maloney N, Hardman CA, Hodgkins CE, Moshoyiannis H, Finlayson G, Scott C, Raats MM, Harrold JA, Raben A, Halford JCG, Martinez JA. Impact of acute consumption of beverages containing plant-based or alternative sweetener blends on postprandial appetite, food intake, metabolism, and gastro-intestinal symptoms: Results of the SWEET beverages trial. Appetite. 2023 May 1;184:106515. doi: 10.1016/j.appet.2023.106515. Epub 2023 Feb 26.
PubMed 36849009
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sweeteners and Sweetness Enhancers: Short-term Impact on Food Behaviour, Physiology & Health (Phase 1)
- ClinicalTrials.gov ID
- NCT04483180
- Acronym / sponsor ID
- SWEET-WP2-P1 / 774293-WP2-P1
- Conditions
- Glycemic Index, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- University of Leeds, University of Copenhagen, University of Liverpool, University of Surrey, Bioiatriki HEALTHCARE GROUP
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 23 Jul 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.
Within the SWEET project (EU funded), in Work Package 2 there are two phases, this study refers to Phase 1 of the SWEET WP2 project, which will be a coordinated trial across 3 intervention centres, University of Navarra (UNAV), University of Liverpool (ULIV) and University of Copenhagen (UCPH). It will involve an acute intervention in 120 individuals to explore initial acceptance, safety and post-prandial effects of 3 S\&SE blends delivered in beverage format.
The main endpoints of the SWEET WP2 Phase 1 study will be glycaemic and lipaemic responses; eating behavior (subjective appetite, food preference, cravings, reward), and health effects (rebound hunger, G.I. side effects and metabolic effects). This phase will be exploratory and will not involve any specific primary hypotheses.
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 and neuro-behavioural processes involved in satiety, consumer preference and health, and to explore mechanistic processes, genetic background, safety issues and consumer perspectives.
There are 4 products being tested in 4 different formulations (sucrose-sweetened beverage control vs. 3 reformulated beverages with S\&SE). Each product will be tested at 3 intervention sites in double-blind cross-over trials with 40 subjects per site, tested per product. Therefore a total of 120 subjects will take part across the 3 intervention sites (UNAV, ULIV, UCPH).
Using identical procedures each trial will consist of 4 Clinical Investigation Days (CIDs) scheduled 7-11 days apart for each of the 3 product formulations.
The total duration of WP2 Phase 2 per site is 6 months, including a minimum of 22 days and a maximum of 34 days for each participant.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Multi-centre crossover study with 4 conditions using balanced block randomisation. The three centres will follow different randomisation sequences but will all test the same 4 conditions (University of Navarra, University of Copenhagen, University of Liverpool).
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Comparison of sweetener blends in liquid form (cross-over study)Beverage containing a sucrose solution. Same aspect and flavor than the experimental beverages. About 1/4 of participants will start with this beverage first. |
| Sucralose / acesulfame K | Experimental | Other: Comparison of sweetener blends in liquid form (cross-over study)Beverage containing a blend of sweeteners based on sucralose and acesulfame K. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first. |
| Stevia rebaudioside A / thaumatin | Experimental | Other: Comparison of sweetener blends in liquid form (cross-over study)Beverage containing a blend of sweeteners based on stevia rebaudioside A and thaumatin. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first. |
| Mogroside V / stevia rebaudioside M | Experimental | Other: Comparison of sweetener blends in liquid form (cross-over study)Beverage containing a blend of sweeteners based on mogroside V and stevia rebaudioside M. Same aspect and flavour than the control beverage. About 1/4 of participants will start with this beverage first. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age: 18-60 years.
- BMI: 25 to 35 kg/m2.
- For women: Use of contraceptive methods or not planning to become pregnant for the duration of the study.
- Regular consumption of sugar-containing foods and willing to consume artificially-sweetened beverages (a score of ≥ 5 on the short sFFQ Part 1a and answer Yes to all questions in Part 2).
- Able to participate on the visit days/CIDs during normal working hours.
Key exclusion criteria (33 listed)
- Blood donation < 3 month prior to study.
- Deficient nutrition or hydration status as identified from the pre-screening/screening session (i.e. absence of disease including anaemia, BMI >18 kg/m2, or other criteria as determined by the study doctor).
- 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 of 20 or more on the EAT-26 test.
- Currently dieting to lose weight or having been on weight cycles (i.e. repeatedly lost and re-gained weight) 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 |
|---|---|---|
| Comparison of sweetener blends in liquid form (cross-over study)The aim is to compare the effects of different sweetener blends on glycemia, subjective appetite parameters and safety parameters when consumed in a beverage as part of a breakfast | Other | Control, Mogroside V / stevia rebaudioside M, Stevia rebaudioside A / thaumatin, Sucralose / acesulfame K |
Primary outcome
Blood glucose area under the curve (AUC)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Area Under the Curve (AUC) for blood glucose (120 min post-intake)
Blood Insulin AUC
Time frame: Clinical Investigation Day 1, 2, 3, 4
Area Under the Curve for blood Insulin (120 min post-intake)
Hunger iAUC
Time frame: Clinical Investigation Day 1, 2, 3, 4
Incremental Area Under the Curve for hunger (120 min post-intake)
Fasting Blood glucose
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting blood glucose
30 min Blood glucose
Time frame: Clinical Investigation Day 1, 2, 3, 4
Blood glucose at 30 min post-intake
60 min Blood glucose
Time frame: Clinical Investigation Day 1, 2, 3, 4
Blood glucose at 60 min post-intake
90 min Blood glucose
Time frame: Clinical Investigation Day 1, 2, 3, 4
Blood glucose at 90 min post-intake
120 min Blood glucose
Time frame: Clinical Investigation Day 1, 2, 3, 4
Blood glucose at 120 min post-intake
Fasting Blood insulin
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting blood insulin
30 min Blood insulin
Time frame: Clinical Investigation Day 1, 2, 3, 4
Blood insulin at 30 min post-intake
60 min Blood insulin
Time frame: Clinical Investigation Day 1, 2, 3, 4
Blood insulin at 60 min post-intake
90 min Blood insulin
Time frame: Clinical Investigation Day 1, 2, 3, 4
Blood insulin at 90 min post-intake
120 min Blood insulin
Time frame: Clinical Investigation Day 1, 2, 3, 4
Blood insulin at 120 min post-intake
Fasting Hunger (VAS registered)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting subjective appetite questionnaire. Visual Analogue Scale
5 min Hunger (VAS registered)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Subjective appetite questionnaire. Visual Analogue Scale at 5 min post-intake
15 min Hunger (VAS registered)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Subjective appetite questionnaire. Visual Analogue Scale at 15 min post-intake
30 min Hunger (VAS registered)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Subjective appetite questionnaire. Visual Analogue Scale at 30 min post-intake
45 min Hunger (VAS registered)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Subjective appetite questionnaire. Visual Analogue Scale at 45 min post-intake
60 min Hunger (VAS registered)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Subjective appetite questionnaire. Visual Analogue Scale at 60 min post-intake
120 min Hunger (VAS registered)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Subjective appetite questionnaire. Visual Analogue Scale at 120 min post-intake
180 min Hunger (VAS registered)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Subjective appetite questionnaire. Visual Analogue Scale at 180 min post-intake
37 secondary outcomes
Fasting Blood cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min Blood cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min Blood cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
90 min Blood cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min Blood cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting Triglycerides
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min Triglycerides
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min Triglycerides
Time frame: Clinical Investigation Day 1, 2, 3, 4
90 min Triglycerides
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min Triglycerides
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting HDL-cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min HDL-cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min HDL-cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
90 min HDL-cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min HDL-cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting LDL-cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min LDL-cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min LDL-cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
90 min LDL-cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min LDL-cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting Alanine aminotransferase (ALT)
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min Alanine aminotransferase (ALT)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting Aspartate aminotransferase (AST)
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min Aspartate aminotransferase (AST)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Weight
Time frame: Visit 0 (screening), Clinical Investigation Day 4
Height
Time frame: Visit 0 (screening)
Body Mass Index (BMI)
Time frame: Visit 0 (screening), Clinical Investigation Day 4
Waist Circumference (WC)
Time frame: Visit 0 (screening)
Hip Circumference (HC)
Time frame: Visit 0 (screening)
Waist-to-hip ratio (WHR)
Time frame: Visit 0 (screening)
Leeds Food Preference Questionnaire (LFPQ)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Liking (VAS registered)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting FG21
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min FG21
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min FG21
Time frame: Clinical Investigation Day 1, 2, 3, 4
90 min FG21
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min FG21
Time frame: Clinical Investigation Day 1, 2, 3, 4
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 22 Aug 2022.
- Derived from this study: PubMed 36849009Almiron-Roig E, Navas-Carretero S, Castelnuovo G, Kjolbaek L, Romo-Hualde A, Normand M, Maloney N, Hardman CA, Hodgkins CE, Moshoyiannis H, Finlayson G, Scott C, Raats MM, Harrold JA, Raben A, Halford JCG, Martinez JA. Impact of acute consumption of beverages containing plant-based or alternative sweetener blends on postprandial appetite, food intake, metabolism, and gastro-intestinal symptoms: Results of the SWEET beverages trial. Appetite. 2023 May 1;184:106515. doi: 10.1016/j.appet.2023.106515. Epub 2023 Feb 26.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of sweetener blends in liquid form (cross-over study) in people with Glycemic Index and Overweight and Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 3 sites in 3 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 33 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 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Spain, 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?
Blood glucose area under the curve (AUC) (time frame: Clinical Investigation Day 1, 2, 3, 4). The study lists 21 primary outcomes in all. 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 NCT04483180, 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 22 Aug 2022.