Healthy
Conditions
Brief summary
This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study. Study Primary Objective: • To assess improvement in bloating symptoms Study Secondary Objectives: * To assess safety and tolerability of the formulation * To compare the time taken for perceptual improvement in bloating/distention * Enzyme blood assays * To assess quality of life indices
Interventions
DIETARY_SUPPLEMENTPlacebo
Eligible subjects will receive Placebo to take daily for six weeks
DIETARY_SUPPLEMENTDietary Supplement with Active Ingredient Blend
Eligible subjects will receive Active supplement to take daily for six weeks
Sponsors
Olly, PBC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent to participate in the study. * Willingness to actively participate in the study and to come to the scheduled visits. * Female and/or male * From 18 to 85 years of age * Patients with self-reported abdominal bloating, abdominal distention, flatulence, and abdominal discomfort either after meals or not at least 3x a week for a minimum of the past 2 weeks
Exclusion criteria
* Drug addicts, alcoholics. * AIDS, HIV-positive or infectious hepatitis * Diabetes mellitus * Disorders known to affect GI motility such as gastroparesis or amyloidosis. * Disorders with GI symptoms such as irritable bowel syndrome, inflammatory bowel disease and celiac disease * History of surgery known to alter the normal function of the GI tract. * Conditions which exclude participation or might influence the test reaction/evaluation. * Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area. * Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years. * Documented allergies to cosmetic products and/or ingredients * Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) within the last 6 weeks prior to the start of the study and/or throughout the entire course of the study. * Oral steroids within the last 4 weeks prior to the start of the study and/or throughout the entire course of the study * Oral or systemic therapy with antibiotics within the last 3 months prior to the start of the study and/or throughout the entire course of the study * Subjects who were treated with biologics within the last 6 months prior to the start of the study and/or throughout the entire course of the study. * One of the following illnesses if not medicated: cardiovascular diseases, thyroid hyperfunction, asthma, hypertension.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Digestive Quality of Life Questionnaire (DQLQ) scores | from enrollment to end of study at 8 weeks | To assess changes in scores related to bloating, diarrhea, constipation and heartburn on quality-of-life indicators, comparing active supplement to placebo group |
| Changes in Symptom Severity Score (Diary) | from enrollment to end of study at 8 weeks | Patients filled out the symptoms diary that had questionnaires of bowel habits. Abdominal pain and bloating were rated on a 100-point visual analogue scale with 0=none and 100=severe, comparing active supplement to placebo group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Gastrointestinal Short Form Questionnaire (GSFQ) Scores | from enrollment to end of study at 8 weeks | To assess changes in gastrointestinal symptoms comparing active supplement to placebo group |
| Changes in Stool Consistency (Bristol Stool Scale) | from enrollment to end of study at 8 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. |
Countries
United States
Outcome results
None listed