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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT01539369
Eligibility Criteria:
Inclusion Criteria:
* Female
* 18-48 years of age (premenopausal)
* Self reported good health
* Body Mass Index (BMI) within overweight/obese range (26-35kg/m2)
* Willingness to consume study foods and prepared to eat breakfast cereals as part of the intervention
* Non-smokers or given up more than 6 months ago
* Exercising no more than 4 times per week at a medium intensity
* Weight stable in the last 3 months (fluctuation of no more than 3kg)
* Current fibre intake (≤ 15g/day) according to DINE and verified by 7 day food diary (fibre points)
* Ability to adequately understand verbal and written information in English
Exclusion Criteria:
* Menopausal or showing menopausal symptoms (e.g. frequent/recurrent hot flushes) at screening or taking any supplements for menopausal symptoms
* Type 2 Diabetes; Cardiac pacemaker fitted
* Taking medication and/or supplements known to affect appetite/body weight in the last 6 months (e.g. asthma, steroids, anti-depressants)
* BMI outside range of 26-35 kg/m2
* Food allergies or aversions to foods likely to be consumed within the study (e.g. wheat bran, nuts)
* Non-smokers or given up more than 6 months ago
* Exercising more than 4 times per week at a medium intensity
* Shift work (night shifts)
* Pregnant or planning a pregnancy within the next year; having been pregnant or lactating within the previous 6 months
* No history of, or current eating disorders as determined using the Eating Attitudes Test (EAT-26;Gardner et al., 1982; a score higher than 20)
* Current fibre intake (\>15g/day according to DINE)
* Insufficient English language skills to complete all study questionnaires
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
48 Years
Study:
NCT01539369
Study Brief:
Protocol Section:
NCT01539369