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Interactions Between Diet, Intestinal Microbiota and Metabolomics

Diet, Intestinal Microbiota and Metabolomics: Evaluation of Possible Synergies

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03475368
Enrollment
60
Registered
2018-03-23
Start date
2018-04-01
Completion date
2019-04-01
Last updated
2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition Disorders

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.

Interventions

People randomized to this interventional group will take a vegetarian diet (i.e. without animal products, except milk and eggs).

OTHERLow carbs diet

People randomized to this interventional group will take low carbs diet (i.e. with a limited amount of carbohydrates)

OTHERMediterranean diet

People randomized to this interventional group will take a traditional Mediterranean diet.

Sponsors

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Changes in weightAt baseline and after two months.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026