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

NCT03071718 | Completed DMC

• 1 other identifier: Federico II University
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

cardiovascular diseases; gut microbiota; Mediterranean diet

Outcome Measures

Primary Outcomes (2)

• Changes in fasting plasma lipids

  Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides

  2months

• Changes in faecal levels of short chain fatty acids

  measure of short chain fatty acids from faecal samples

  2months

Secondary Outcomes (11)

• Changes in faecal microbiome

  2months

• Changes in urinary TMAO concentration

  2months

• Variation of serum polyphenols concentration

  2months

• Variation of serum gastro-intestinal hormone concentration

  2months

• Variation of serum gastro-intestinal hormone concentration

  2months

Study Arms (2)

Med-D

EXPERIMENTAL

Subjects will follow a Mediterranean diet for two months

Other: Mediterranean diet

Cont-D

ACTIVE COMPARATOR

Subjects will follow a control diet for two months

Other: Control Diet

Interventions

Mediterranean diet OTHER

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.

Med-D

Control Diet OTHER

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.

Cont-D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects having any chronic or metabolic diseases, food allergies, or following a dietary regimen or medication \<3 months preceding the study will be excluded.

Sponsors & Collaborators

• Paola Vitaglione: lead

Study Sites (1)

Federico II University

Naples, 80131, Italy

Location

Related Publications (1)

• Tagliamonte S, Laiola M, Ferracane R, Vitale M, Gallo MA, Meslier V, Pons N, Ercolini D, Vitaglione P. Mediterranean diet consumption affects the endocannabinoid system in overweight and obese subjects: possible links with gut microbiome, insulin resistance and inflammation. Eur J Nutr. 2021 Oct;60(7):3703-3716. doi: 10.1007/s00394-021-02538-8. Epub 2021 Mar 24.

  PMID: 33763720 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Cardiovascular Diseases

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Paola Vitaglione, Professor

  Department of Agricultural Sciences, Federico II University

  STUDY DIRECTOR

• Danilo Ercolini, Professor

  Department of Agricultural Sciences, Federico II University

  STUDY CHAIR

• Angela Rivellese, Professor

  Department of Clinical and Experimental Medicine, Federico II University

  PRINCIPAL INVESTIGATOR

• Ilario Mennella, PhD

  Department of Agricultural Sciences, Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 7, 2017
• Study Start: June 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: February 1, 2019
• Last Updated: July 19, 2019

Record last verified: 2019-07

Locations

IT (1)