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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT05601635
Eligibility Criteria:
Inclusion Criteria:
* Subject is a male or female, 18 years of age, inclusive.
* Subject has a BMI of 20.0-30.0 kg/m2, inclusive and a weight ≥ 110 lb. at the screening visit.
* Subject is willing to maintain his/her usual physical activity pattern throughout the study period.
* Subject is willing to follow study instructions, including compliance with certain dietary restrictions, consumption of study products, and study visit schedule.
* Subject is judged to be in good health on the basis of the medical history.
* Subject is willing to abstain from alcohol consumption for 24 hours prior to the study visit.
* Subject is willing to maintain a stable dose of current medications not interfering with study outcomes, including birth control, throughout the study duration.
* Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator/s and is willing to complete study procedures.
Exclusion Criteria:
* Subject has fasting finger prick glucose \>125 mg/dL.
* Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at the screening visit.
* Subject has had major trauma or a surgical event within 2 months of study visit 1.
* Subject has had a weight change ≥4.5 kg within 2 months of visit, taking weight loss drugs, or has had bariatric surgery or other weight reduction surgery (ie. liposuction, laser fat removal, etc)
* Subject has a history or presence of clinically important endocrine, cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary, or gastrointestinal disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
* Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
* Subject has a history of extreme dietary habits, as judged by the Investigator (e.g., Atkins diet, etc.).
* Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
* Subject has a known intolerance or sensitivity to any ingredients in the study products.
* Subject has used medications known to influence carbohydrate and lipid metabolism, including, but not limited to adrenergic blockers, diuretics, hypoglycemic medications, and systemic corticosteroids 2 weeks prior to visit 0 and throughout the study or other medication(s) that may interfere with results of study.
* Subject taking fiber supplements.
* Subject taking systemic steroids, extreme alcohol use, or drug user.
* Subject has a vein access score of less than 7
* Subject is a female who is pregnant, planning to be pregnant during the study period or lactating.
* Subject is a current smoker. Past smoker abstinence for less than 1 years.
* Subject has participated in any clinical trial within 30 days prior to enrollment unless otherwise approved by the study Investigator.
* Subjects who are vegan or vegetarian
* Subjects who work overnight shift (e.g 3rd shift)
* Subject who donated blood within the last 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05601635
Study Brief:
Protocol Section:
NCT05601635