Interactions Between Diet, Intestinal Microbiota and Metabolomics

Diet, Intestinal Microbiota and Metabolomics: Evaluation of Possible Synergies

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.

Study Overview

• Status: Unknown
• Conditions: Nutrition Disorders
• Intervention / Treatment: Other: Vegetarian diet; Other: Low carbs diet; Other: Mediterranean diet

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari
    • Castellana, Bari, Italy, 70013
      • Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vegetarian diet; People randomized to interventional groups will take a vegetarian diet (i.e. without animal products, except milk and eggs)	Other: Vegetarian diet; People randomized to this interventional group will take a vegetarian diet (i.e. without animal products, except milk and eggs).
EXPERIMENTAL: Low carbs; People randomized to interventional groups will take a low carbs diet (i.e. with a limited amount of carbohydrates).	Other: Low carbs diet; People randomized to this interventional group will take low carbs diet (i.e. with a limited amount of carbohydrates)
ACTIVE_COMPARATOR: Mediterranean diet; People randomized to interventional groups will take a mediterranean diet (i.e. with low glycemic index carbohydrates and vegetables).	Other: Mediterranean diet; People randomized to this interventional group will take a traditional Mediterranean diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in weight	At baseline and after two months.

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Publications and helpful links

General Publications

• Zimmer J, Lange B, Frick JS, Sauer H, Zimmermann K, Schwiertz A, Rusch K, Klosterhalfen S, Enck P. A vegan or vegetarian diet substantially alters the human colonic faecal microbiota. Eur J Clin Nutr. 2012 Jan;66(1):53-60. doi: 10.1038/ejcn.2011.141. Epub 2011 Aug 3.
• Turnbaugh PJ, Ley RE, Hamady M, Fraser-Liggett CM, Knight R, Gordon JI. The human microbiome project. Nature. 2007 Oct 18;449(7164):804-10. doi: 10.1038/nature06244.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ANTICIPATED): April 1, 2019
• Study Completion (ANTICIPATED): April 1, 2019

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (ACTUAL): March 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: 36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No