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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT01849302
Eligibility Criteria:
Inclusion Criteria:
* Healthy males and females
* Age range 18-50 years
* Normal weight and overweight people as classified by BMI:22-27.9 kg/m2 (inclusive).
* Weight stable (within 3 kg) two months prior to study inclusion
* Understanding English well and feeling comfortable speaking it
Exclusion Criteria:
* Dietary protein consumption \>25% energy from protein
* Had surgery in the previous 12 months
* Have suffered a myocardial infarction or stroke at any time
* Suffer from any blood-clotting disorder or prescription of any medication affecting blood clotting
* Suffer from any metabolic disorders (e.g. diabetes, metabolic syndrome or hypertension)
* Any requirement to take long-term medication, especially those active on the gastro-intestinal tract or for cardio-vascular disease
* Any dietary restrictions or recently/currently on a weight reducing diet
* Irregular eating patterns or not regularly consuming breakfast
* Food allergies (e.g. milk protein allergies) or intolerances (e.g. lactose)
* Use of medication which affects food intake or behaviour (e.g. anti-depressants)
* Use of medication likely to affect taste, smell or appetite
* Eating restraint based on the three Factor Eating Questionnaire
* Use of any protein supplements
* A history of alcohol or drug misuse (the average daily number of units of alcohol considered as acceptable is 2-3 units women; 3-4 units men
* Smoking
* Athletes in training (\>10 h exercise/week)
* Female that is breast-feeding, pregnant, or if of child-bearing potential and are not using effective contraceptive precautions
* Involvement in a study involving an experimental drug/medication within 3 months prior to entry of this study
* Blood pressure \> 160/90 mmHg
* Vegan or Vegetarian
* Glucose \> 6 mmol/L
* Gamma glutamyl transferase \> 1.9 μkat / L
* Alanine transaminase \> 1.1 μkat / L
* Cholesterol \> 6.5 mmol/L
* Triglycerides \> 2.0 mmol/L
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01849302
Study Brief:
Protocol Section:
NCT01849302