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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT00374218
Eligibility Criteria:
Inclusion Criteria:
* males or non-pregnant and non-lactating females
* aged 20-50
* normally drink at least 2 cans (680ml) regular soft-drinks or sugar sweetened drinks per day
* high waist circumference (≥102cm (40in) in men or ≥88cm (34.5in) in women)
Exclusion Criteria:
* Body mass index \>35.0kg/m²
* Subjects whose weight is not stable (varied by \>5% of current weight over the past 6 months).
* Subject who regularly undertake \>30min vigorous physical activity per week.
* Diabetes based on current treatment with insulin or an oral hypoglycemic agent or fasting glucose ≥7.0mmol/L on screening
* Fasting triglycerides ≥10.0mmol/L
* Severe liver dysfunction (transaminase \>180% of upper limit of normal)
* Severe renal impairment (serum creatinine \>140% of upper limit of normal)
* Any major medical or surgical event within 6 months
* History of inflammatory bowel disease, malabsorption, or other disorder or drug use affecting gastrointestinal motility or the absorption of nutrients
* Use of drugs which affect glucose or lipids except: stable doses (3 months) of statins, fibrates, beta-blockers, diuretics.
* Substance abuse
* Simultaneous participation in another clinical trial
* Any other condition which, in the opinion of Dr. Wolever, might make the subject's participating harmful to him(her)self or others or affect the results
* Inability to understand spoken and written English
* Unwilling or unable to consume the test foods (drinks and nutrition bars) and/or to undergo the test procedures
* Unwilling or unable to give informed consent and/or sign the consent form
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT00374218
Study Brief:
Protocol Section:
NCT00374218