Status:
COMPLETED
Work Package 2 Phase 1 - Beverages Study
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Collaborating Sponsors:
University of Leeds
University of Copenhagen
Conditions:
Glycemic Index
Overweight and Obesity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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, Un...
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...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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).
Key Trial Info
Start Date :
August 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04483180
Start Date
August 14 2020
End Date
June 30 2021
Last Update
August 22 2022
Active Locations (3)
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1
University of Copenhagen
Frederiksberg, Denmark
2
Centre for Nutrition Research, University of Navarra
Pamplona, Navarre, Spain, 31008
3
University of Liverpool
Liverpool, United Kingdom