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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT06628869
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, age ≥20 to ≤50 y at Visit 1 (Day -7).
2. BMI ≥18.5 to less than 30.0 kg/m2 at Visit 1 (Day -7).
3. Non-user (never used, or former user defined as cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period.
4. Willing to maintain habitual diet, physical activity, and body weight throughout the trial.
5. Willing to refrain from exclusionary medications, supplements, and products throughout the study.
6. No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
7. Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Exclusion Criteria:
1. Known sensitivity, intolerability, or allergy to any of the study products or their excipients.
2. Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, gastroesophageal reflux disease requiring any medication, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies).
3. Recent (within 2 weeks of Visit 1; Day -7) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as ≥3 loose or liquid stools/d).
4. Self-reported history (within 6 weeks of Visit 1; Day -7) of constipation (defined as fewer than 3 bowel movements per week).
5. Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
6. Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -7). Stable use of hypertension medication is allowed \[defined as no change in medication regimen within the 3 months prior to Visit 1 (Day -7)\].
7. Have received a COVID-19 vaccine within 2 weeks of randomization or expected to receive a COVID-19 vaccine during the study period.
8. Had a positive SARS-CoV2 test and experienced symptoms for more than 2 months (i.e. "long-haulers").
9. Extreme dietary habits (e.g., vegetarian, vegan, Atkins diet, etc.) at the discretion of the Clinical Investigator.
10. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
11. Major trauma or any other surgical event within 3 months of Visit 1 (Day -7).
12. Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1 (Day -7). The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to Visit 1 (Day -7).
13. Weight loss or gain more than 4.5 kg in the 3 months prior to Visit 1 (Day -7).
14. Currently or planning to be on a weight loss regimen during the study.
15. Use of weight loss medications, incretin mimetics, and/or GLP-1 agonists in the 3 months prior to Visit 1 (Day -7).
16. Consumption of supplemental inulin/chicory root or inulin/chicory root-fortified foods and beverages equivalent to more than 10 g inulin per day within 1 month of Visit 1 (Day -7).
17. Antibiotic use within 3 months of Visit 1 (Day -7) and throughout the study period.
18. Use of steroids within 1 month of Visit 1 (Day -7) and throughout the study period.
19. Habitual use (i.e., daily) of marijuana and hemp products including CBD products within 30 days of Visit 1 (Day -7).
20. Chronic use (i.e., daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDS) within 1 month of Visit 1 (Day -7).
21. Use of medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function, including but not limited to, digestive enzymes, pre- and probiotic supplements as well as foods or beverages containing live probiotics (e.g., yogurt, kombucha), fiber supplements, laxatives, enemas, suppositories, H2 blockers, proton pump inhibitors, antacids, anti-diarrheal agents, anti-depressants, and/or anti-spasmodics within 2 weeks of Visit 1 (Day -7) and throughout the study period. Standard multivitamin and mineral supplements are allowed.
22. Participated in endoscopy or endoscopy preparation within 3 months prior to Visit 1 (Day -7).
23. Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Day -7).
24. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. Participants who are pregnant during the study will be discontinued.
25. Recent history (within 12 months of screening; Visit 1; Day -7) of alcohol or substance abuse. Alcohol abuse is defined as more than 14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
26. Receipt or use of study products in another research study within 4 weeks prior to Visit 2 (Day 0) or longer if the previous study product is deemed by the Clinical Investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
27. Has a condition the Clinical Investigator believes would interfere with the participant's ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the participant at undue risk.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT06628869
Study Brief:
Protocol Section:
NCT06628869