Skip to main content
Clinical Trials/NCT03475368
NCT03475368
Unknown
Not Applicable

Diet, Intestinal Microbiota and Metabolomics: Evaluation of Possible Synergies

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis1 site in 1 country60 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutrition Disorders
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Enrollment
60
Locations
1
Primary Endpoint
Changes in weight
Last Updated
8 years ago

Overview

Brief Summary

It is widely known that the quality of the diet is able to modify the expression of many bacterial genes populating the intestine of the host, as well as the type of bacteria themselves. This is also expressed with a more or less evident and troublesome after meals symptomatology that many patients complain to the health care staff.

A good composition of the microbiota is crucial for the health of the individual, both at the intestinal level as well as at the systemic level because, depending on the type of food substrate available at the intestinal level, metabolites will be produced capable of positively or negatively affect the health of the individual.

In fact, scientific evidence shows the existence of the causal link between the health of the microbiota and the genesis of inflammatory diseases not only intestinal, but also systemic, and even of cancer, obesity, metabolic syndrome and atherosclerosis.

The recent diffusion of gene sequencing techniques has brought significant developments in the study of the human and bacterial genome, which allow to produce enormous quantities of sequences at a lower cost and at a higher speed than previous techniques.

Therefore the clinical Nutrition Clinic of the IRCCS De Bellis in Castellana Grotte (BA) proposes to check if changes in the intestinal microbiota correlate, not only with anthropometric and clinical-laboratory parameters, but also with the typical symptoms of irritable bowel syndrome (IBS), a functional pathology very widespread with the advent of the modern era, in which, a diet rich in sugars and proteins of animal origin and poor in plant foods, is unfortunately common also in the areas of the Mediterranean basin.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
April 1, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Responsible Party
Principal Investigator
Principal Investigator

Gioacchino Leandro

Director of Gastroenterology and Clinical Nutrition

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Eligibility Criteria

Inclusion Criteria

  • No major comorbidities with a life expectancy less than 12 months;
  • BMI between 29 and 33 kg/m2
  • Serum cholesterol 200-260 mg/dl
  • Serum triglycerides \> 150 mg/dl

Exclusion Criteria

  • Antibiotics or prebiotics in the 3 months before the enrollment;
  • Use of statins or other medications for lowering cholesterol;
  • Menopause;
  • Previous history of cancer.

Outcomes

Primary Outcomes

Changes in weight

Time Frame: At baseline and after two months.

Study Sites (1)

Loading locations...

Similar Trials