Dietary Supplements for Reduction of Intestinal Permeability Levels
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Zonulin levels in feces
Study Overview
Brief Summary
A randomised and controlled trial, in which the effect of a dietary supplement is evaluated for reduction of intestinal permeability levels of subjects with high levels of zonulin in feces
Detailed Description
Randomized clinical trial, with masking of the statistician and the evaluator, to assess the effect of a food supplement, composed of substances that promote intestinal mucosa repair, on the levels of zonulin in feces and consequently on intestinal permeability. A control group of subjects not receiving any type of supplementation will be used to compare the effectiveness of the treatment.
The main objective of this study is to determine if the use of a dietary supplement composed of glutamine, butyrate and lion's mane, among others, corrects the levels of zonulin in feces.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects between 18 and 65 years of age with elevated levels of zonulin in stool (greater than 80 ng/ml).
Exclusion Criteria
- •Taking any type of antibiotic in the last month
- •Taking prebiotics or probiotics products in the last month.
- •Taking laxatives in the last month.
- •Undergoing any medicinal treatment
- •Pregnancy
- •Subject with a history of current gastrointestinal pathology or disorder such as: acute colon pathology, acute haemorrhagic colitis, suspected digestive perforation, recent abdominal surgery, severe arterial hypertension, abdominal hernia, colon neoplasia, history of cardiac syncope, renal failure, liver cirrhosis, epilepsy, severe psychiatric illness (psychosis), necrosis due to abdominal irradiation, severe anaemia, severe neurovegetative lability.
Arms & Interventions
Dietary supplement Group
Subjects belonging to the experimental group will be provided with the PermeaIntest supplement, which they will take for 60 days, 1 sachet in the morning and 1 sachet in the evening in half a glass of water. Subjects will have a stool sample collected before and after ingestion of the dietary supplement.
Intervention: Dietary supplement Group (Dietary Supplement)
Control group
A control group of subjects not receiving any type of supplementation will be used to compare the effectiveness of the treatment. Subjects will have a stool sample collected before and after a period of 60 days
Outcomes
Primary Outcomes
Zonulin levels in feces
Time Frame: 60 days
Zonulin levels in feces, assessed in ng/ml
Secondary Outcomes
No secondary outcomes reported
Investigators
Isidro Fernández López
Principal investigator
Universidad Complutense de Madrid