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

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

Interventions

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.

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.

Sponsors & Collaborators

• Paola Vitaglione

  lead OTHER

Principal Investigators

• Paola Vitaglione, Professor · Department of Agricultural Sciences, Federico II University

• Danilo Ercolini, Professor · Department of Agricultural Sciences, Federico II University

• Angela Rivellese, Professor · Department of Clinical and Experimental Medicine, Federico II University

• Ilario Mennella, PhD · Department of Agricultural Sciences, Federico II University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2017-07-31

Completion

2019-02-28

Countries

• Italy

Study Locations