Personalized Modulation of Microbiota
Condition: Obesity; Microbial Colonization; Nutrition Disorders
MeSH terms: Communicable Diseases; Infections; Nutrition Disorders
Study type: Interventional

Summary: 
      Intestinal flora or microbiota is the group of bacteria that live in the intestine, in a
      symbiotic relationship with the human body. It is estimated that human beings have around
      2,000 different bacteria species. The gut microbiota plays a key in many of the body's
      functions. Hence, the analysis of the gut microbiome provides insight into the state of the
      microbiota as an indicator of overall health due to its metabolic, protective and nutritional
      functions. A balanced diet promotes the formation and maintenance of a well-structured
      microbiota, in which the different species of microorganisms cohabit in a balanced and
      controlled system.

      The study is based on the hypothesis that the intake of certain plant-based foods rich in
      various active ingredients (especially non-digestible carbohydrates, certain types of fats
      and polyphenols) can modulate the microbiota and thus improve the health status of the human
      population.

      Taking into account this background, the objective of this study is to assess the effect of
      the inclusion of functional foods and ingredients within a balanced diet on the composition
      of the microbiota and also on health parameters associated with metabolic disease.
    

Detailed description: 
      The 60 volunteers participating in the study who meet the inclusion criteria, will be
      randomly divided into two groups:

        -  Control group (nutritional promotion): volunteers will be provided with basic
           nutritional recommendations based on a Mediterranean diet.

        -  Experimental group (Nutribiota): volunteers will be instructed to follow a dietary
           strategy similar to the control group, but including the functional foods and
           ingredients developed by the companies with the aim to promote a balanced and specific
           diet associated with improvements in the composition of the microbiota and metabolic
           parameters of the volunteers.

      The duration of the study are 8 weeks, during which 4 visits are scheduled:

        -  Recruitment: this visit will consist on an initial screening in which the volunteers
           will be informed about the characteristics of the study and will be receive the
           information sheet and the informed consent form to be signed by all those interested in
           participating in the study. Volunteers who meet the inclusion for the study will be
           asked to complete the Food Frequency Questionnaire and Physical Activity Questionnaire
           for the next visit (visit 1). In addition, each participant will be provided with a
           faecal microbiota sample collection kit which they will have to hand in with the
           corresponding sample at the next visit (visit 1).

        -  Clinical investigation day 1 (week 0):after a fasting period of at least 10 hours, the
           nursing staff will take a blood sample to analyze the biochemical parameters and
           metabolomic profile. Anthropometric measurements will be taken from each volunteer
           (weight, height, waist and hip circumference, and body composition analysis by
           bioimpedance) with the collaboration of a dietician. In addition, faecal sample and Food
           Frequency Questionnaire and Physical Activity Questionnaire will be collected.
           Volunteers randomly assigned to the experimental group will be given the dishes and
           functional ingredients designed by the companies, which they will have to incorporate
           into a balanced dietary pattern following the indications given by the dietician.

        -  Clinical investigation day 2 (week 4): In this visit, the adherence of the volunteers to
           the study will be monitored and the weight of the volunteers will be registered. In
           addition, all study volunteers will be given a faecal microbiota sample collection kit,
           which should be handed in with the corresponding sample at the final visit. Moreover,
           Food Frequency Questionnaire and Physical Activity Questionnaire will be given to each
           volunteer in order to be filled for the final visit. Volunteers who belong to the
           experimental group will be given dishes and functional ingredients.

        -  Clinical investigation day 3 (week 8): Faecal sample, Food Frequency Questionnaire and
           Physical Activity Questionnaire will be collected. The procedures in this visit will be
           the same as in visit 1, but dishes and functional ingredients will not be given to the
           volunteers.
    

Intervention name(s): Four-foods eating guidelines; No designed-foods eating guidelines
Intervention type(s): Other; Other
Intervention description(s): To follow a healthy eating pattern and consume four (4) foods designed for the study (extra virgin olive oil with olive leaf extract, chickpea dish with spinach, vegetable cream dish, and olive fiber) and to follow a healthy eating pattern.; To follow a healthy eating pattern. Their diet is not accompanied by the four newly designed foods of the other group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Fecal microbiota; Nutrition; Diet; Insulin