Circular Economy and the Design of Healthy and Sustainable Food and Ingredients
Condition: Overweight; Sustainability; Food; Microbiota; Habits
MeSH terms: Overweight
Study type: Interventional

Summary: 
      There is a need to change eating patterns towards healthier diets with new sources of
      non-animal protein, obtained through more sustainable systems in line with strategies such as
      the European Green Deal, the "Farm to Fork" strategy, or the Common Agricultural Policy,
      among others.

      The objective of this study, is to evaluate the nutritional effect of the developed products
      and their impact on the improvement and/or prevention of health problems (diabetes,
      intestinal dysbiosis), as well as to design and evaluation of the effect on health of a
      vegetable protein-based nutraceutical that also includes fiber and resistant starch.
    

Detailed description: 
      This study is designed as a 3-week, randomised, parallel study, focused on overweight/obese
      men and women between 20 and 65 years old.

      All participants attend the Nutrition Intervention Unit of the Center for Nutrition Research
      in the University of Navarra for 2 times during the intervention (day 1 and day 21).

      RECRUITMENT AND SCREENING:

      The recruitment and screening of participants will be carried out through a Google Form
      questionnaire and by a phone call. At the same time, the database of people interested in
      participating in nutritional studies of the Center for Nutrition Research will be used, who
      will be contacted by phone or email to offer them the study. In addition, the study
      information and the recruitment form will also be posted on the Center for Nutrition Research
      website for anyone who wants to enroll in the study. On the other hand, the study will be
      disseminated through the channels available in the University of Navarra (Unclic, Alumni,
      emails, etc.) and through the placement of informative posters in the different buildings of
      the University of Navarra, as well as in public and private centers in Navarra, with prior
      authorization. If it is necessary, the study will be disseminated in the media such as in
      press, radio and TV.

      The staff of the Nutritional Intervention Unit will assess the data provided by the potential
      participants and those who meet the inclusion criteria will be cited for the first visit of
      the study, which will take place in the Nutritional Intervention Unit of the Center for
      Nutrition Research in the University of Navarra. The information sheet and the informed
      consent will be sent to them beforehand so that they can read it for visit 1.

      CLINICAL INVESTIGATION DAY 1 (day 1):

      It will be carried out in groups of 10 people, who will attend the facilities of the
      University of Navarra fasting for at least 10 hours. The volunteers will be received by the
      nutritionist and the study nurse. Once gathered, proceed as follows:

        -  Welcome, detailed explanation of the study procedures and resolution of doubts.

        -  Delivery of the information sheet and the informed consents to the volunteers.

        -  Those volunteers who want to participate will sign the informed consent. Then, the
           procedures for taking samples and data will begin.

             -  Delivery of 2 kits for collecting stool samples (beginning and end). The sample
                collected at the beginning will be delivered within three days to the facilities of
                the Nutritional Intervention Unit.

             -  Delivery of a food consumption frequency questionnaire and a gastrointestinal
                symptoms questionnaire. They will be filled out with the help of the nutritionist
                during the visit and will refer to the last 3 weeks.

             -  Delivery of the VAS hunger-satiety questionnaire to be completed 1-2 days before
                the final visit.

             -  The dietician-nutritionist will take the anthropometric measurements of the
                volunteers individually and with light clothing.

             -  The nurse will draw blood (2 serum tubes of 5 mL).

             -  Delivery of the nutraceutical under study or the control nutraceutical (see
                composition in Table 1) as well as indications for the three weeks of the study.
                The nutraceutical should be consumed daily for 3 weeks as a substitute for
                breakfast in both groups.

             -  The date and time for the final visit (visit 2) will be specified.

      CLINICAL INVESTIGATION DAY 2 (day 21):

      It will be carried out in groups of 10 people, who will have to attend the University of
      Navarra fasting for at least 10 hours. The volunteers will be received by the nutritionist
      and the study nurse. Once gathered, proceed as follows:

        -  Collection of stool samples and VAS hunger-satiety questionnaire.

        -  General talk to welcome everyone and ask about the course of the 3 weeks.

        -  The dietitian-nutritionist will take the anthropometric measurements of the volunteers
           individually and with light clothing.

        -  The Food Frequency Questionnaire and the Gastrointestinal Symptoms Questionnaire
           corresponding to the final visit will be completed with the help of the nutritionist.
           They will refer to the 3 weeks that the intervention lasts.

        -  The volunteer will complete the Nutraceutical Acceptance Questionnaire.

        -  The nurse will draw blood (2 serum tubes of 5 mL).
    

Intervention name(s): Dietary recommendations including experimental nutraceutic.; Dietary recommendations including control nutraceutic.
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Volunteers allocated in the control group will receive every day and during 3 consecutive weeks the experimental nutraceutic instead of the breakfast. Nutraceutical intake will be accompanied by nutritional advice to follow for the 3 weeks of intervention.; Volunteers allocated in the control group will receive every day and during 3 consecutive weeks the control nutraceutic instead of the breakfast. Nutraceutical intake will be accompanied by nutritional advice to follow for the 3 weeks of intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Overweight; Microbiota; Sustainability; New food; Food ingredients