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:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT04162457
Eligibility Criteria:
Inclusion Criteria:
* Age 18 - 40 years
* BMI between 18.5-25 kg/m2
* Registered to a GP
* Non-restrained eaters, restraint eating score on the Dutch Eating Behaviour Questionnaire (DEBQ) ≤ 3
* Healthy - general good health
* Currently not taking any medication (other than females taking the oral contraceptives or over the counter medication such as paracetamol)
* Normal or corrected vision
* Right-handedness (including left-handers could bias the results because of the laterality of brain functions)
* Regular breakfast eaters (≥5 times per week)
* Stable weight, ± 5 kg last 3 months
* No self-reported food allergy or intolerance to foods supplied during the study
* No or low NNS consumers (up to 1 can of diet soda per week or 1 sachet of NNS per week)
* Willing to comply with the study protocol
* Willingness to be informed about chance findings of pathology
* The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* The participant is able to read, comprehend and record information written in English.
* A signed and dated written informed consent is obtained from the participant.
Exclusion Criteria:
* Habitual NNS consumers, \>1 can of diet beverage or \>1 table packet of sweeteners per week
* Subjects who have a non-removable metal object in or at their body, such as, for example: heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
* Tattoos, that are older than 15 years
* Claustrophobia
* Pathological hearing ability or an increased sensitivity to loud noises
* Operation less than 3 months ago
* Acute illness or infection during the last 4 weeks
* Moderate or severe head injury
* Any metabolic (e.g. metabolic disorder, diabetes, insulin resistance), psychological (e.g. depression), gastrointestinal or neurological (e.g. epilepsy, headache disorder, multiple sclerosis, traumatic brain injuries) diseases or medication in relation to these diseases.
* Currently experiencing anxiety or depression
* Use of recreational substances in the last month
* Age under 18 years or over 40 years old.
* BMI \>25 kg/m2 and \<18.5 kg/m2
* Restrained eaters (DEBQ for restraint eating ≥ 3)
* Current weight loss regimens, or more than 5 kg weight loss/gain in the last 3 months
* Subjects who follow special diets for weight maintenance, such as Atkins Diet, Weight Watchers, gluten-free diet, The Zone diet, Vegetarian Diet, Raw Food Diet etc.
* Subjects having breakfast less than 5 times per week.
* Eating disorders (binge eating disorder, bulimia etc)
* Current or past history of drug or alcohol dependency - alcohol consumption exceeding 14 units a week
* Female participants who are, or may be, pregnant, or currently lactating.
* Subjects who regularly consume dietary supplements for weight loss, muscle building etc.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04162457
Study Brief:
Protocol Section:
NCT04162457