Gut dysbiosis Digestive System
Conditions
Interventions
The active intervention (Opunxia™) is a highly concentrated extract of Opuntia Ficus Indica cladodes containing a high amount of cladode polysaccharides
Sponsors
BIONAP srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 25-50 years 2. Reading, understanding and signing approval of the informed consent 3. Computer literate and exposed to computerized tests 4. Available and willing to follow the procedure of the study protocol
Exclusion criteria
Exclusion criteria: 1. Subjects 50 years old 2. Clinical history with the relevant presence of any disorder or administration of drugs/food supplement that can potentially interfere with the treatment under study 3. Consumption of any drugs or food supplements that can interfere with intestinal activity 4. Smokers 5. Lack of compliance (defined as not using the correct Opuntia™ dose or placebo for>1 week), and inability to give informed consent 6. BMI =30 kg/m² 7. Pregnant and lactating women 8. Excessive alcohol consumption (>5 drinks/week) 9. Subjects with a history of drug, alcohol, and other substance abuse 10. Known food intolerance or food allergy 11. Subjects involved in a clinical or food study within the previous month 12. Subjects who have unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension, hypotension, diabetes mellitus, kidney failure) 13. Subjects with a history of paralysis or cerebral vascular accident 14. Subjects with active cancers or on chemotherapy 15. Other factors that limit their ability to cooperate during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal flora evaluated by microbiome analysis using 16S rRNA gene sequencing at screening and after 4 and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Weight and BMI management and control measured by a balance and a meter at screening and after 4 and 8 weeks 2. Intestinal permeability measured using zonulin levels in faeces at screening and after 4 and 8 weeks 3. Gastrointestinal health measured using the GERD Symptom Assessment Scale (GSAS) and Gastrointestinal Quality of Life Index (GIQLI) validated questionnaires at screening and after 4 and 8 weeks 4. Hip and waist measurement using a flexible meter at screening and after 4 and 8 weeks | — |
Countries
Italy
Outcome results
None listed