Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract

Study Overview
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Brief Summary
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This study will assess global small molecule profiles identified in the human gastrointestinal tract of healthy human volunteers.

Detailed Description
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The gut is home to an extensive interaction between the host and its microbiota, in different regions exposed to endogenous and exogenous signals, such as nutrition, medications, immune alterations, and geographical location-related factors. this study aims to characterize the small molecule profiles of a cohort of healthy individuals, including their polar, semi-polar, non-polar, and protein landscape. The investigators will develop a pipeline enabling to integrate these small molecule profiles with a variety of inter-individual readouts, as assessed in stools of healthy volunteers. Data will be used to characterize molecular patterns potentially associated with a variety of dietary, immune, and health-related human features, with an aim to characterize small molecules for future causative investigation.

Official Title
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Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract

Conditions
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Nutrition, Healthy

Intervention / Treatment
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* Other: nutritional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal BMI Age 18-70 Exclusion Criteria: Known food allergies to the tested food items Chronic constipation (less than one bowel movement every two days) Chronic treatment with any drug upon enrolment. The use of systemic antibiotics, probiotics, or proton pump inhibitors 3 months prior to enrollment. Diagnosis of type 1 or type 2 diabetes. Any chronic disease at the discretion of the study team- such as active or recent cancer, inflammatory bowel disease, systemic autoimmunity Any psychiatric disorders Alcohol or substance abuse Gut-related surgery, including bariatric surgery, but not including previous appendectomy. Pregnancy, breastfeeding, or fertility treatments 6 months prior to enrollment for female participants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional intervention<br>The trial will consist of two short periods in which increased intake of a pair of food items will be implemented. The first pair of food items is apples and bananas (pair A), and the second pair of food items is peanuts and cucumbers (pair B). | Other: nutritional<br>* participants will receive 2 pairs of food items to consume - pair A - Bananas and Apples, pair B - cucumbers and peanuts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of gut microbiota and associated molecules in the healthy human gastrointestinal tract upon nutritional supplementation | Identification of changes in fecal microbiota and associated molecules using multi-dimensional analysis of fecal samples collected during a nutritional intervention. The analysis includes - a shot-gun metagenomics, metabolomics and proteomic anlaysis. The analysis includes - proteomics, metabolomics and a shot-gun metagenomics. | 1 month |