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 @ 4:34 AM
Ignite Modification Date:
2025-12-25 @ 4:34 AM
NCT ID:
NCT03993418
Eligibility Criteria:
Inclusion Criteria:
* Age 18-40 years
* BMI 18.5-25 kg/m2
* No or low NNS consumers (up to 1 can of diet soda per week or 1 sachet of NNS per week)
* DEBQ for restraint eating ≤ 3
* Healthy - general good health
* Not taking medications that affect metabolism or appetite (i.e. thiazide diuretics, glucocorticoids or beta blockers)
* Stable weight, ≤ 5 kg last 12 months
* Fasting blood glucose ≤6.0 mmol/L
* Willing to comply with the study protocol
* No self-reported food allergy or intolerance to foods supplied during the study
* 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:
* Age under 18 years or over 40 years old.
* BMI \>25 kg/m2 and \<18.5kg/m2
* Participants who are not willing to comply with study procedures (including expression of dislike for NNS)
* Habitual NNS consumers, \>1 can of diet beverage or \>1 sachet of low calorie sweeteners per week.
* Fasting blood glucose measured \> 6 mmol/L
* Subjects who are currently dieting and having ceased a diet in \< 4 weeks
* DEBQ score for restraint eating \> 3
* 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.
* Vegetarians, vegans
* Subjects who take recreational substances such as cannabis.
* Presence of any chronic condition requiring medication that might affect our results (e.g. diabetes, mental diseases, gastrointestinal diseases)
* Subjects with eating disorders (binge eating disorder, bulimia etc)
* Subjects who are currently experiencing anxiety or depression
* Participants who drink alcohol more than the NHS guidelines (14 units per week)
* \>10 h of vigorous physical activities per week and/or planning to increase/decrease physical activity levels in the next months.
* Having ceased smoking in the last six months
* Female participants who are, or may be, pregnant, or currently lactating.
* Subjects who regularly consume dietary supplements for weight loss, muscle building etc.
* Subjects with food allergies or intolerances related to the study.
* Subjects who have given blood elsewhere within the last month.
* The participant cannot read, comprehend and record information written in English.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03993418
Study Brief:
Protocol Section:
NCT03993418