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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT05129735
Eligibility Criteria:
Inclusion Criteria:
* Male or Female between 18-75 years old
* Diagnosed with type 2 diabetes for at least 3 months
* HbA1c of 7.5 to 10% inclusive
* BMI of 27 to 40 kg/m2
* If on any medication, treated with a stable dose for at least 90 days
* Must be in good health (don't report any medical conditions asked in the screening questionnaire)
* Willing and able to provide written informed consent
* Must have a Glucometer at home
Exclusion Criteria:
* Diagnosis of type 1 diabetes
* Have a history of severe hypoglycemia or hyperglycemia requiring hospitalization within the prior 6 months
* Use of dietary supplements or meal-replacement shakes targeted at diabetes and unwilling to stop using them for the duration of the study
* Allergies to any test product ingredients
* Has any of the following medical conditions:
* Oncological conditions
* Psychiatric disease
* Cardiovascular disease: any hospitalization within the past 3 months
* Multiple Sclerosis
* Gastrointestinal conditions such as Celiac disease, Crohn's disease, etc.
* Any other severe chronic disease
* History of drug or alcohol abuse
* Females who are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding during the course of the study
* Participation in a clinical research trial within 30 days prior to screening
* Participating in an investigational health product research study
* Any disorder, unwillingness, or inability, which in the investigator's opinion, might jeopardize the individual's safety or compliance with the protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05129735
Study Brief:
Protocol Section:
NCT05129735