Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diet-induced Arrangement of the Gut Microbiome for Improvement of Cardiometabolic Health (DINAMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071718
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Paola Vitaglione, Federico II University

Brief Summary:
Mediterranean diet (Med-D) has been recognized as an intangible cultural heritage by UNESCO and was shown to be beneficial for the treatment of obesity, type-2 diabetes and cardiovascular diseases. Individuals with the highest adherence to Med-D (classified according to Sofi et al., 2010) were characterized by increased levels of specific fibre-degrading bacteria, increased faecal levels of short chain fatty acids, and lower urinary concentrations of the atherogenic compound TMAO. However, the interplays between Med-D and microbial populations in the intestine remain unclear. Moreover, a number of clinical conditions like obesity, T2D, and atherosclerosis are associated with dysbiotic microbial ecosystems in the gut, i.e., shifts in the structure and function of the microbiota, but the characteristic features of dysbiotic gut communities and the impact of diet are not very well defined. The present study will evaluate the impact of Med-D on cardiometabolic health in human subjects via modification of intestinal microbial communities and its impact on health outcomes, mainly related to inflammatory, oxidative and hormonal status, in overweight subjects.

Condition or disease Intervention/treatment Phase
Overweight Obesity Other: Mediterranean diet Other: Control Diet Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Diet-induced Arrangement of the Gut Microbiome for Improvement of Cardiometabolic Health
Study Start Date : June 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: Med-D
Subjects will follow a Mediterranean diet for two months
Other: Mediterranean diet

Subjects in the Med-D group will be assigned a personalized diet prepared on the basis of own eating habits as established by 7-d food diary recalls. Energy values of habitual diets will be kept unchanged during Med-D intervention. Briefly, Med-D will be prepared so as to achieve a weekly consumption of:

  • 7 portions of milk or yogurt plus whole grain cereals,
  • 7 portions of nuts (30g)
  • At least 3 portion of absolute legumes
  • 14 portions of vegetables
  • 21 portions of fruit
  • 4 portions of whole grain pasta
  • 3 portions of whole grain pasta with vegetables or legumes
  • 7 portions of whole grain bread
  • 3 portions of fish
  • Extravirgin olive oil as unique source of discretional fats All subjects will be requested not to change physical activity levels during the 8 week intervention period.

Active Comparator: Cont-D
Subjects will follow a control diet for two months
Other: Control Diet
Control subjects will not change their habitual diet during intervention. All subjects will be requested not to change physical activity levels during the 8 week intervention period.




Primary Outcome Measures :
  1. Changes in fasting plasma lipids [ Time Frame: 2months ]
    Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides

  2. Changes in faecal levels of short chain fatty acids [ Time Frame: 2months ]
    measure of short chain fatty acids from faecal samples


Secondary Outcome Measures :
  1. Changes in faecal microbiome [ Time Frame: 2months ]
    Measure of faecal microbiome

  2. Changes in urinary TMAO concentration [ Time Frame: 2months ]
    measure of urinary TMAO (μM)

  3. Variation of serum polyphenols concentration [ Time Frame: 2months ]
    Measure of serum polyphenols concentration (nmol/L)

  4. Variation of serum gastro-intestinal hormone concentration [ Time Frame: 2months ]
    Measure of plasma GLP-1 concentrations (mg/dL)

  5. Variation of serum gastro-intestinal hormone concentration [ Time Frame: 2months ]
    Measure of plasma GIP concentrations (mg/dL)

  6. Variation of serum gastro-intestinal hormone concentration [ Time Frame: 2months ]
    Measure of plasma Glucagon concentrations (mg/dL)

  7. Variation of serum gastro-intestinal hormone concentration [ Time Frame: 2months ]
    Measure of plasma Ghrelin concentrations (mg/dL)

  8. Variation of serum gastro-intestinal hormone concentration [ Time Frame: 2months ]
    Measure of plasma Insulin concentrations (mg/dL)

  9. Variation of plasma endocannabinoids concentration [ Time Frame: 2months ]
    Measure of plasma endocannabinoids concentrations (mg/dL)

  10. Variation of blood pressure [ Time Frame: 2months ]
    Measure of blood pressure (mmHg)

  11. Changes in fasting inflammatory blood markers [ Time Frame: 2months ]
    Measure of plasma C-reactive protein (mmol/L)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subject will be selected by interviews on health status, dietary and behavioural lifestyle factors, anthropometric data and a 7-d food diary recall.

Inclusion criteria are:

  • men and women aged 18-65;
  • BMI>24kg/m2;
  • a diet characterized by low adherence to Med-D, with absence of any food supplements and alternative medication;
  • intake of fruit/vegetables < 3 servings/d;
  • a low level of physical activity (< 500 metabolic equivalent min/week).

Exclusion Criteria:

  • Subjects having any chronic or metabolic diseases, food allergies, or following a dietary regimen or medication <3 months preceding the study will be excluded.
  • Participation in other clinical trials, pregnancy or lactation are also exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071718


Locations
Layout table for location information
Italy
Federico II University
Naples, Italy, 80131
Sponsors and Collaborators
Paola Vitaglione
Investigators
Layout table for investigator information
Study Director: Paola Vitaglione, Professor Department of Agricultural Sciences, Federico II University
Study Chair: Danilo Ercolini, Professor Department of Agricultural Sciences, Federico II University
Principal Investigator: Angela Rivellese, Professor Department of Clinical and Experimental Medicine, Federico II University
Principal Investigator: Ilario Mennella, PhD Department of Agricultural Sciences, Federico II University
  Study Documents (Full-Text)

Documents provided by Paola Vitaglione, Federico II University:

Layout table for additonal information
Responsible Party: Paola Vitaglione, Associate Professor, Federico II University
ClinicalTrials.gov Identifier: NCT03071718    
Other Study ID Numbers: Federico II University
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will decide as soon as we will have data analysis completed and a clear idea on publication rute according with the other coauthors.
Keywords provided by Paola Vitaglione, Federico II University:
cardiovascular diseases
gut microbiota
Mediterranean diet
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight
Signs and Symptoms