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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT04133805
Eligibility Criteria:
Inclusion Criteria:
* Must be a randomized controlled clinical trial with either a parallel or cross-over design
* have a treatment period of at least 3 weeks
* Hypercholesterolemic or normocholesterolemic adults, overweight and obese individuals or individuals with diabetes were all acceptable
* Sources from β-glucan oats, β-glucan barley, konjac, psyllium, guar gum, and pectin were accepted
* The amount of soluble fiber must be reported or measured or must be computable.
* Must be appropriately controlled.
* Must measure one of LDL-C, non-HDL-C or ApoB. These lipid measures can be either primary or secondary outcomes.
* Enough information must be provided to calculate the magnitude of effect, i.e. end of treatment measures and/or change from baseline measures
Exclusion Criteria:
* If the study was insufficiently controlled, i.e. the control was another soluble fiber
* If the soluble fiber was a combination supplement or in whole food sources where the amount of soluble fiber could not be isolated
* If the outcome measures did not include LDL-C, non-HDL-C or ApoB
* If the treatment period was less than 3 weeks
* If the study was from a non-adult population
* If the study provided insufficient information to calculate a magnitude of effect
* Secondary information such as reviews, editorials, commentaries, were excluded
* If the dose was less than 0.4g/day
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04133805
Study Brief:
Protocol Section:
NCT04133805