Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT02591134
Eligibility Criteria:
Inclusion Criteria:
* BMI ≥ 27.0 and ≤ 35.0 kg/m2
* Healthy
* Age between 18 and 65 years (inclusive)
* Regular consumer of cold NNS or water beverages (\>3 per week but \< 2 litres per day)
* Acceptance of randomization to either a water or NNS beverage condition
* Willing to abstain from consuming NNS beverages (if randomized to the water condition) and SSBs for the duration of the trial.
* Provided voluntary written informed consent
* Not planning on moving outside of the local area in the next 24 months
* Two individuals from the same household complying with the inclusion and exclusion criteria will be permitted to participate in the trial however, in such instances, the individuals will be randomized to the same group
Exclusion Criteria:
* Not willing to discontinue drinking NNS beverages for the duration of the trial should they be assigned to the water group and vice versa;
* Not willing to consume NNS beverages or water for the duration of the trial;
* Expressing a significant dislike of NNS beverages (at least moderately likeable on a 5 point likert scale);
* Excess consumer of chilled beverages or NNS beverages (more than 2 litres a day);
* A BMI below 27 or above 35 kg/m2;
* Below the age of 18 or above 65 years;
* A first year University Student (to avoid the 'freshman 15' phenomenon of weight gain within the first year of attending University);
* Significant health problems (including a history of cardiovascular diseases);
* Gastro-intestinal problems or diabetes;
* Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study;
* Stated major psychiatric disorder (made clear by medicines specified);
* Current depression (made clear by medicines specified);
* Currently being treated for a psychological condition;
* Being pregnant, planning to become pregnant, breastfeeding or less than 6 months post-partum;
* Planning on moving away from the local area within the next two years;
* History of anaphylaxis to food; known food allergies or food intolerance;
* Dislike of \> 25% of the study foods offered on the appetite probe day (Subset 1 only);
* Non breakfast eaters (subset 1 only);
* Smoking or having ceased smoking in the last six months;
* Currently dieting, having ceased a diet in less than 4 weeks, or having lost significant amounts of weight in the previous year;
* Engaging in regular intense exercise;
* Having significantly changed their physical activity patterns in the past 4 weeks or intending to change them during the study (other than to adhered to advice given in the behavioural intervention);
* Inability to adhere to the programme such as inability to increase activity level;
* Receiving systemic or local treatment likely to interfere with evaluation of the study parameters;
* Working in appetite or feeding-related disciplines;
* Being on specific food avoidance diets;
* Having had bariatric surgery;
* Having abnormal eating behaviour (restrained eaters measured by the Dutch Eating Behaviour Questionnaire - Restraint Scale \[DEBQ-R\] with a cut-off point of more than 4 (van Strien et al,1986); and binge eaters measured by the Binge Eating Scale with a cut-off point of 27 or over (Gormally et al, 1982))
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02591134
Study Brief:
Protocol Section:
NCT02591134