Healthy
Conditions
Brief summary
Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study, where participants will take the Daily Supplement, and record Daily Symptoms, two clinical visits where Hydrogen and Methane Breath Test (HMBT) will be conducted, Abdominal Circumference Measurement will be taken, and two Self Reported Validated Questionnaires: Visual Analogue Scale (VAS) and the Quality of Life Questionnaires.
Interventions
DIETARY_SUPPLEMENTPlacebo
Placebo
DIETARY_SUPPLEMENTDietary Supplement with actives
Dietary Supplement containing blend of Digestive Enzymes, Dandelion, Ginger & Fennel Extracts
Sponsors
Olly, PBC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Adults aged 18-65 years 2. Reported bloating and/or distention occurring at least once per week for the past 6 months, with symptoms actively present during the past 3 months 3. Willingness to avoid probiotics, antibiotics, or other supplements during the study period (unless approved by investigators) 4. Ability to provide informed consent and comply with all protocol requirements
Exclusion criteria
1. Diagnosed gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease, GI malignancies) 2. Use of antibiotics, laxatives, or probiotics within the past 4 weeks 3. Uncontrolled diabetes mellitus 4. Presence of mood disorders or psychiatric illness that may affect symptom perception or study compliance 5. Immunodeficiency, autoimmune conditions, or chronic inflammatory conditions 6. Excessive alcohol intake (\>14 drinks/week for men, \>7 drinks/week for women) 7. Use of medications known to affect gut motility or gas production (e.g., opioids, anticholinergics) 8. Pregnant or breastfeeding women 9. Use of systemic corticosteroids or immunosuppressant drugs. 10. History of reaction to the category of product tested 11. Other diseases or medications that might directly interfere in the study or put the subject's health under risk. 12. Employee of CRO or product manufacturer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the impact of BTB on hydrogen and methane production in healthy adults | From time of enrollement to end of study at Week4 | Participants will take the Hydrogen and Methane Breath Test (HMBT) at baseline and after the study at Week4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To estimate the changes in abdominal circumference as an indicator of distention | From time of enrollement to end of study at Week4 | Standardized tape measurement at the level of the iliac crest or on top of belly button will be used to evaluate changes in abdominal distention at baseline and after the study at Week4. |
| To assess the changes in validated subjective questionnaire (VAS) for bloating, abdominal pain, distension, and flatulence. | From time of enrollement to end of study at Week4 | Participants will take Visual Analogue Scale (VAS) which is a self-reported assessment of bloating and distention severity using PROMIS's GI gas and bloating questionnaire at baseline and after the study at Week4. |
Countries
United States
Outcome results
None listed