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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT03785860
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female adults 18-45 years old
* BMI: 23.0-32.0 kg/m2 ("overweight")
* Current diet includes low quantity of fiber, defined as less than approximately 15g/day, or equivalent to approximately 4 servings of fruit, vegetable, legume, or whole grain combined per day, and determined using diet recall.
* Willingness to consume prebiotic fiber drink daily for 4 weeks, and a placebo drink for 4 weeks, as well as a 4-week washout period with no intervention.
* Willingness to provide diet records, blood samples and stool samples (self-collected) biweekly for the duration of the study (7 total collections).
* Willingness to adhere to "diet control period" biweekly (eating the same, self-selected foods and abstaining from alcohol each day for 3 days prior to each stool collection/blood draw).
* General bowel movement frequency of at least once every three days and maximum of two times per day.
Exclusion Criteria:
* A plan to or desire to lose weight
* Smoker
* Anemia and difficulty with blood draws
* Currently, within previous 6 weeks of the study, or during the study taken probiotic or prebiotic formulations (food products considered to have these properties in their natural or unadulterated forms are acceptable).
* Antibiotic use during the study or within 6 months prior to study commencement.
* Medication: statins, blood pressure medications, other prescription medications
* Pregnant, planning to be pregnant or breast feeding at any point during the study or study enrollment.
* Start or change in use of hormonal birth control in the last 6 months or plans to change or start use of hormonal birth control during the study period
* Allergies to any prebiotic or placebo ingredients - Prebiotic ingredients: Resistant Tapioca Starch, Fructooligosaccharide, Sugarcane Fiber, Agave Inulin, Gum Arabic, Xanthan Gum, Apple Powder, Raspberry Powder, Blueberry Powder / Placebo Blend: Rice Flour, Xanthan Gum, Grape Powder, Plum Powder
* Illness (flu/cold in the last two weeks)
* Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome, hypertension, cancer, or previous cardiovascular events
* Irritable bowel syndrome, celiac disease, or any inflammatory bowel disease (including Crohn's Disease, and/or Ulcerative colitis)
* Any immunosuppression symptoms at any point during the study or study enrollment
* Consumption of \>1 alcoholic drink/day or frequent binge drinking (\>3 alcoholic drinks in one episode) \> 1 day per month
* Plans to change or recent significant changes in lifestyle (e.g. diet or exercise routine, major travel, etc)
* Recent weight fluctuations (greater than 10% in the last six months)
* Regular use of over-the-counter pain medications (\>1/week)
* Taking prescription lipid medications (e.g. statins) or other supplements known to alter lipoprotein metabolism such as isoflavones
* Recent medical procedure such as surgery within the last 6 months
* Any changes in the above during the course of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03785860
Study Brief:
Protocol Section:
NCT03785860