Microbiome-Tailored Food Products Based On Typical Mediterranean Diet Components
Condition: Microbiota; Overweight and Obesity; Metabolic Complication
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The composition and functions of the microbiome impact human metabolism and health status.
      Diet plays a fundamental role in shaping the structure of the gut microbiome, modulating the
      interaction between the gut microbiome and the human host. Western dietary patterns including
      a high consumption of red and processed meat, refined grains and sugars, and dairy products
      have been associated with a high incidence of chronic diseases. It is widely recognised that
      there is a higher consumption of plant-based foods in Mediterranean countries than in other
      Western countries. The Mediterranean diet involves a high intake of fruits, vegetables,
      legumes, nuts, minimally processed cereals, moderate consumption of fish and a low
      consumption of saturated fats, meat and dairy products with regular intake of extra virgin
      olive oil. The Mediterranean diet reduces the incidence of cardiovascular, metabolic and
      neurodegenerative diseases. Interesting results emerged from the evaluation of the
      microbiome-metabolome interaction, which shows that individuals with the highest adherence to
      the Mediterranean diet had much higher levels of short-chain fatty acids (SCFAs) and
      increased levels of the beneficial fiber-degrading bacteria compared to subjects with low
      adherence to the Mediterranean diet. The study of the effect on the microbiota of specific
      foods with anti-inflammatory/antioxidant properties is interesting and of potential clinical
      impact.
    

Detailed description: 
      The composition and functions of the microbiome impact human metabolism and health status.
      Dietary habits play a fundamental role in shaping the structure of the gut microbiome,
      modulating the interactions between the gut microbiome and the human host. Western dietary
      patterns, including a high consumption of red and processed meat, refined grains and sugars,
      and dairy products, have been associated with a high incidence of chronic diseases. It is
      widely recognised that there is a higher consumption of plant-based foods in Mediterranean
      countries than in other Western countries. The Mediterranean diet involves a high intake of
      fruits, vegetables, legumes, nuts, minimally processed cereals, moderate consumption of fish
      and a low consumption of saturated fats, meat and dairy products with regular intake of extra
      virgin olive oil. The Mediterranean diet (MD) reduces the incidence of cardiovascular,
      metabolic and neurodegenerative diseases. Interesting results emerged from the evaluation of
      the microbiome-metabolome interaction, which shows that individuals with the highest
      adherence to the Mediterranean diet had much higher levels of short-chain fatty acids (SCFAs)
      and increased levels of the beneficial fiber-degrading bacteria compared to subjects with low
      adherence to the Mediterranean diet. The study of the effect on the microbiota of specific
      foods with anti-inflammatory/antioxidant properties is interesting and of potential clinical
      impact.

      Extent and evaluation of current knowledge directly linked to the scientific question(s) to
      be answered by the clinical study: The Mediterranean diet exerts beneficial effects on health
      status. Evidence has shown that the two mechanisms by which consuming a Mediterranean diet
      patterns may contribute to improved metabolic health are modulation of the gastrointestinal
      microbiota and reduction of metabolic endotoxemia.

      Outcomes (efficacy, safety) of completed and number of ongoing clinical studies utilising the
      same intervention in the same indication: The available evidence focuses on a broader concept
      of food and nutrient consumption, which do not consider that the beneficial effect of the
      Mediterranean Diet might due to the synergic and interactive combinations of nutrients,
      rather than to isolated nutrients.

      Level of evidence related to the mechanism of action of the intervention in the planned
      clinical study population: Although several studies have shown the effects of Mediterranean
      dietary pattern on health status by modulating intestinal microbiota, a comprehensive
      evaluation of the synergetic and combined effects of selected dietary pattern on metabolic
      patterns as well as on the intestinal microbiota and its metabolites is still not totally
      clarified and recognized.

      Objective(s) of the clinical study:

        -  Primary objective: to explore the effect of a "SuperFood" based on Mediterranean diet
           components (e.g. dietary fibre, polyphenols, flavonoids and glucosinolates) on the
           structure and functions of the gut microbiome (bacteria, fungi and viruses) and on the
           metabolome in subjects with low adherence to Mediterranean Diet.

        -  Secondary objectives: to explore the effect of a "SuperFood" based on Mediterranean diet
           components (e.g. dietary fibre, polyphenols, flavonoids and glucosinolates) on the
           metabolic, inflammatory, and oxidative status, and to define taxonomic and metabolic
           differences.

      Characteristics of the study population (size, age group, sex distribution, inclusion and
      exclusion criteria; all items with justification!):

      Upon signing of the informed consent, 40 healthy volunteers (20 subjects in placebo group and
      20 subjects in SuperFood treatment group, comparable sex ratio) with BMI<30 kg/m2 and with
      low adherence to Mediterranean diet will be enrolled.

      Inclusion Criteria:

        -  Subjects able to sign the Informed Consent

        -  Age 30-60 years;

        -  BMI 25-29.9 kg/m2

        -  Low adherence to the Mediterranean diet (adherence score between 0-5)

      Exclusion Criteria:

        -  Subjects not able to provide informed consent

        -  obesity (BMI> 30 kg /m2), diabetes, altered thyroid function, food allergies, intestinal
           disease, liver, kidney, or other organ/apparatus pathologies, regular use of drugs or
           food supplements, consumption of antibiotics in the 3 months prior to the experiment or
           need for a specific diet, pregnancy /lactation.

        -  SARS-CoV-2 infection

      Details on sample size and power calculation:

      The investigatres considered that a sample of 120 healthy subjects gives sufficient power to
      detect significant differences regarding certain bacterial strains and metabolites following
      the consumption of Mediterranean diet components, considering that during the intervention
      there could be a drop-out rate of 20%.

      Design of the clinical study (controlled / uncontrolled; randomised; open / blinded; parallel
      group / cross over / other; please justify the appropriateness of the selected design) A
      blinded- and placebo-controlled randomized clinical study of 8 weeks evaluating the possible
      beneficial effects of a well-selected Mediterranean diet components. Subjects will be
      randomly assigned to a SuperFood or placebo (blinded) treatment in a 1:1 ratio.

      Type of intervention:

      The intervention consists of consumption of SuperFood" based on Mediterranean diet components
      (e.g., dietary fibre, polyphenols, flavonoids and glucosinolates).
    

Intervention name(s): Placebo; SuperFood
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The group will have to consume a jar every day (approx. 75 ml) which contain (water, malt-dextrins, 0.1% starch, 0.1% guar gum, flavorings and colorants); The group will have to consume a jar of superfood (vegetable smoothie) every day. The jar will be filled with approx. 75 ml which corresponds to about 75 g. The superfood formulated by the University of Bolzano on the basis of the results and evidence acquired in collaboration with the Istituto Superiore di Sanità. Composition: pomegranate, walnuts, moringa, broccoli, according to the proportions indicated in Annex 2. This mixture has been analyzed by an external laboratory and authorized for human use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Microbiota; Mediterranean diet; Overweight; Metabolic syndrome