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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT00457756
Eligibility Criteria:
Inclusion Criteria:
* LDL-C 110 - 190 mg/dL
* For current lipid-lowering prescription therapy users, the dose of lipid-lowering medication must have been constant for 3 months with no current plan for change in dose.
* Age 18 - 85 years
Exclusion Criteria:
* Type 1 diabetes
* Severe hypertension, defined as at least 180 / 100 mmHg
* Any other health condition that may interfere with the study results, as judged by the principle investigator
* Allergy against any of the ingredients in the tested product
* Any medical condition, in which fiber consumption is contraindicated (e.g. Crohn's disease
* The use of nutritional supplements during the last two months containing one or more similar ingredients, as the tested supplement.
* History of alcohol or drug abuse, psychological or other mental issues that are likely to invalidate informed consent, or limit the ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed product concomitantly or within one month prior to entry into the study
* Pregnant or breast feeding
* Persons who eat only 1 meal per day
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00457756
Study Brief:
Protocol Section:
NCT00457756