Interactions Between Diet, Intestinal Microbiota and Metabolomics
Primary Purpose
Nutrition Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Vegetarian diet
Low carbs diet
Mediterranean diet
Sponsored by
About this trial
This is an interventional treatment trial for Nutrition Disorders
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.
Sites / Locations
- Azienda ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Vegetarian diet
Low carbs
Mediterranean diet
Arm Description
People randomized to interventional groups will take a vegetarian diet (i.e. without animal products, except milk and eggs)
People randomized to interventional groups will take a low carbs diet (i.e. with a limited amount of carbohydrates).
People randomized to interventional groups will take a mediterranean diet (i.e. with low glycemic index carbohydrates and vegetables).
Outcomes
Primary Outcome Measures
Changes in weight
Secondary Outcome Measures
Full Information
NCT ID
NCT03475368
First Posted
March 16, 2018
Last Updated
April 27, 2018
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
1. Study Identification
Unique Protocol Identification Number
NCT03475368
Brief Title
Interactions Between Diet, Intestinal Microbiota and Metabolomics
Official Title
Diet, Intestinal Microbiota and Metabolomics: Evaluation of Possible Synergies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
April 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vegetarian diet
Arm Type
Experimental
Arm Description
People randomized to interventional groups will take a vegetarian diet (i.e. without animal products, except milk and eggs)
Arm Title
Low carbs
Arm Type
Experimental
Arm Description
People randomized to interventional groups will take a low carbs diet (i.e. with a limited amount of carbohydrates).
Arm Title
Mediterranean diet
Arm Type
Active Comparator
Arm Description
People randomized to interventional groups will take a mediterranean diet (i.e. with low glycemic index carbohydrates and vegetables).
Intervention Type
Other
Intervention Name(s)
Vegetarian diet
Intervention Description
People randomized to this interventional group will take a vegetarian diet (i.e. without animal products, except milk and eggs).
Intervention Type
Other
Intervention Name(s)
Low carbs diet
Intervention Description
People randomized to this interventional group will take low carbs diet (i.e. with a limited amount of carbohydrates)
Intervention Type
Other
Intervention Name(s)
Mediterranean diet
Intervention Description
People randomized to this interventional group will take a traditional Mediterranean diet.
Primary Outcome Measure Information:
Title
Changes in weight
Time Frame
At baseline and after two months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Azienda ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
City
Castellana
State/Province
Bari
ZIP/Postal Code
70013
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21811294
Citation
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.
Results Reference
background
PubMed Identifier
17943116
Citation
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.
Results Reference
background
Learn more about this trial
Interactions Between Diet, Intestinal Microbiota and Metabolomics
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