| Registry | NCT06794619 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: quadruple, supportive care |
| Enrollment | 34 (Actual) |
| Sponsor | Olly, PBC (Industry) |
| Conditions | Healthy |
| Interventions | Placebo, Dietary Supplement with actives (Dietary supplement) |
| Dates | start 2025-02-03, primary completion 2025-08-01 (estimated), completion 2025-08-01 (estimated), first posted 2025-01-27, last updated 2025-07-15 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of Placebo All trials of Dietary Supplement with actives
Randomized, Crossover, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with Daily Food Log, Stool Samples, Blood Draws, and Validated Questionnaires (GSRS, Bristol stool chart, and DQLQ) with Oral Dietary Supplement
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo | Oral dietary supplement. Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day. |
| Dietary Supplement with actives | Active comparator | Dietary Supplement: Dietary Supplement with actives | Oral dietary supplement. Instructions: Instructions: Take 1 gummy per day with or without food or water. Do not take more than 1 gummy per day. |
Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers
Inclusion Criteria: * Subject is a healthy male or female between the ages of 18 - 50 years, inclusive; * Subject indicates they have mild or moderate occasional digestive issues (bloating or mild discomfort) with no diagnosed chronic digestive or immune conditions; * Subject has signed a written Informed Consent and is willing and able to attend all visits and comply with study instructions; * Subject agrees to maintain their regular diet and exercise habits; * Subject agrees to limit alcohol consumption to 1 drink per day or no more than 7 drinks per week. * Females Only: Female subject of childbearing potential must agree to be on a form of birth control for at least 6 months prior to screening visit. Acceptable forms of birth control are: Abstinence (not having heterosexual sex), same-sex partner, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream), vasectomized partner for at least 6 months prior to the screening visit. Birth control (such as the pills, intravaginal ring, or the arm implant) are not acceptable forms of birth control. * Subject agrees not to take any dietary supplements or medications throughout the clinical study; * Subject agrees to have four blood draws taken at the testing facility and agrees to collect stool samples (four times) as instructed. * Subject has an active email address and is capable of completing online questionnaires. Exclusion Criteria: * Subject has severe digestive issues (e.g., IBS, Crohn's Disease, Ulcers, Severe Constipation, etc.); * Subject has allergies to dietary supplements or their ingredients; * Subject is currently taking medication(s) for a chronic condition; * (Females of Child Bearing Potential only) Subject is pregnant, nursing, or planning to become pregnant; * Subject has significant past/current medical history (e.g., previous diagnosis of gastrointestinal or metabolic conditions, cancer, liver or kidney disease); * Subject has any disease or condition (e.g., hepatic, multiple sclerosis, high blood pressure, renal, Thrombosis/Phlebitis, cardiac, pulmonary, digestive, hematological, neurological, locomotor or psychiatric disease) which in the opinion of the Investigator would compromise the safety of the subject; * Subject has travel plans and would be unable to attend all study visits; * Subject is currently taking any dietary supplements, vitamins and/or medications; * Subject is currently taking probiotics related to digestion or any products that may impact gut microbiota (e.g. probiotic supplements, yogurt, and/or fermented drinks); * Subject has used antibiotics in the last 3 months; * Subject has a positive medical history for cancer within the past 5 years; * Subjects has any planned surgeries and/or invasive medical procedures during the study; * Subjects is considered unreliable or unlikely to be available for the duration of the study; * Subject is an employee of the clinical site or the sponsor
| Facility | City | Country | Status |
|---|---|---|---|
| Princeton Consumer Research | St. Petersburg, Florida | United States |