Evaluation of a food supplement (Opunxia™) in improving intestinal health

Not Applicable

Completed

• Conditions: Gut dysbiosis; Digestive System

• Registration Number: ISRCTN14562892
• Lead Sponsor: BIONAP srl

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38474715/ (added 17/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-05
• Study Completion: 2023-03-31
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

1. Subjects <25 and >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal flora evaluated by microbiome analysis using 16S rRNA gene sequencing at screening and after 4 and 8 weeks

Secondary Outcome Measures

Name	Time	Method
1. Weight and BMI management and control measured by a balance and a meter at screening and after 4 and 8 weeks<br>2. Intestinal permeability measured using zonulin levels in faeces at screening and after 4 and 8 weeks<br>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<br>4. Hip and waist measurement using a flexible meter at screening and after 4 and 8 weeks