Healthy
Conditions
Brief summary
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
Interventions
DIETARY_SUPPLEMENTPlacebo
Placebo
DIETARY_SUPPLEMENTDietary Supplement with actives
Dietary Supplement containing probiotic and prebiotic ingredients
Sponsors
Olly, PBC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Gastrointestinal Symptoms (GSRS) Scores | from enrollment to end of study at 10 weeks | Weekly GSRS scores will be analyzed to assess changes in the severity and frequency of gastrointestinal symptoms across the active and placebo arms. Data will be compared between the active supplement and placebo groups and within each participant across different time points to measure crossover effects. |
| Changes in Stool Consistency (Bristol Stool Chart) | from enrollment to end of study at 10 weeks | Daily stool consistency ratings will provide data on changes in bowel health and regularity. Average stool consistency scores will be compared across baseline, active treatment, and placebo phases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Gut Microbiome Composition (Stool Samples) | from enrollment to end of study at 10 weeks | Stool samples will be analyzed for changes in microbial diversity and specific bacterial populations, which may indicate changes in gut health. Comparisons will be made between active treatment and placebo periods to identify any significant shifts in the microbiome. |
| Changes in Immune Biomarkers (Blood Samples) Levels | from enrollment to end of study at 10 weeks | Blood sample analysis will focus on immune function biomarkers counts. Changes in immune biomarkers will be compared between baseline, active treatment, and placebo periods. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Daily Diet and Symptoms (Daily Diary) | from enrollment to end of study at 10 weeks | Changes in daily food intake, symptom levels, and stool consistency from the diaries will be analyzed to identify any patterns or correlations between dietary habits and digestive health outcomes. This data will provide exploratory insights into lifestyle factors that may influence supplement effects. |
| Changes in Daily Quality of Life (DQLQ) Scores | from enrollment to end of study at 10 weeks | DQLQ scores will be compared across different phases to assess any impacts of the supplement on participants' well-being and daily functioning. Changes in quality of life will be analyzed at baseline, end of each treatment period, and post-washout. |
| Changes During Initial Dose Effects (24-Hour Questionnaire) | from enrollment to end of study at 10 weeks | Short-Term Effects on Symptoms (24-Hour Data). The 24-hour questionnaire data following the initial dose will be used to capture any immediate digestive effects of the supplement. Changes in reported symptoms within this initial period will be compared between the active supplement and placebo groups. |
Countries
United States
Outcome results
None listed