Nutritional Study on the Beneficial Effects of Canned Fish Consumption on Healthy Adult Population
Condition: Healthy Diet
Study type: Interventional

Summary: 
      There is sufficient evidence on the beneficial effects of fish consumption on health, mainly
      associated with the content of omega-3 polyunsaturated fatty acids (EPA and DHA) present
      mainly in blue fish. Different national and international organizations have issued
      recommendations on the optimal amount of fish that the population should consume to prevent
      certain chronic diseases related to diet. Thus, the WHO recommends eating fish regularly (1-2
      servings per week for healthy adults) to ideally provide the equivalent of 250 mg of omega-3
      fatty acids (EPA + DHA). Not reaching the optimal levels of EPA + DHA increases the risk for
      cardiovascular diseases, increasing the risk of death according to certain epidemiological
      studies. In this sense, using more precise techniques such as membrane lipidomics, allow
      adequate quantification and monitoring of fatty acid levels present in our body and how this
      lipid profile can change according to metabolism and diet. The objective of this study is to
      carry out a clinical trial of nutritional intervention with an adult population without
      pathologies that has a low consumption of fish (<2 servings / week) to evaluate the
      effectiveness of an intervention strategy based on increasing the number of fish servings
      through a controlled intake of fresh and canned fish.

      The results aim to show that increasing fish intake has an impact on lipid metabolism and in
      the future, for the prevention of certain chronic diseases, the introduction of canned fish
      can be a healthy strategy to increase fish consumption to long term.
    

Detailed description: 
      Objectives:

      The main objective of this study is to demonstrate through a nutritional intervention, the
      benefits of the intake of canned fish compared to fresh or frozen fish on lipid metabolism in
      a healthy adult population, which can be divided into three specific objectives:

        -  Assessment of the health benefits of consuming canned fish (controlled intake): impact
           on the fatty acid profile of red blood cell membrane.

        -  Provide evidence of the benefits of consuming canned fish compared to intake fresh /
           frozen fish.

        -  Demystify the bad reputation of canned fish products (as processed foods).

      Study design:

      A prospective, randomized, controlled, parallel-group nutritional intervention clinical trial
      will be carried out with 150 healthy adults between 18 and 65 years for 4 months.
      Participants will be randomized into one of the two equal size intervention groups: "group A:
      fresh/frozed fish" or "group B: canned fish".

      Recruitment and selection of participants:

      AZTI will organize the selection and recruitment process in collaboration with IMQ-Prevention
      (MUTUALIA) through 4 centers in Spain (Zamudio, Bilbao, Vitoria and Donosti) and with the
      OSARTEN Koop clinical analysis laboratory.

      Participants will be distributed according to a random assignment sequence. In this way,
      investigators increase the probability that the two groups (control and intervention) are
      comparable with respect to age and gender.

      Inclusion criteria: Healthy adults (men and women) with 18.5 <BMI < 27 kg/m2. Those
      individuals who usually have a fish intake of less than 1-2 servings per week will be
      included.

      Exclusion criteria: Having been diagnosed with concomitant diseases or chronic disease that
      can modify the results. Having undergone a transplant. Be taking medication and consuming or
      have consumed omega 3 supplements, vitamins, prebiotics.. in the last 4 months before
      starting the study. Allergy to fish or any food.

      Sample size calculation:

      The sample size was calculated with the G * power software based on the defined primary
      objective of observing differences in the lipid profile of the red blood cell membrane
      obtained after the ANCOVA test for fixed effects and interactions. A priori investigators
      expect a mean effect (f = 0.25) for a statistical power of 80.0% (1-β = 0.80) and taking into
      account that the significance level is 5.0%, it will be necessary to include 64 experimental
      units in the control group and 64 units in the experimental group that sum 128 experimental
      units in the study. Taking into account that the expected dropout percentage is around 20.0%,
      a total of 150 experimental units would be necessary in the study.

      Primary outcome:

        1. Metabolic status will be evaluated measuring 12 fatty acids in red blood cell membrane
           (relative %). Omega 3 index (EPA+DHA) as a biomarker of cardiovascular risk and omega-6
           omega-3 ratio as biomarker of inflammatory status will be the main outcomes.
           Investigators will take into accounts the optimal ranges of this fatty acids in red
           blood cell membranes previously reported in the litearature (Ferreri C et al. 2012.
           Expert Rev. Mol. Diagn. 12(7), 767-780).

           Secondary outcomes:

        2. Biochemical parameters: total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL
           cholesterol (mg/dL), triglycerides (mg/dL), glucose (mg/dL), uric acid (mg/dL),
           creatinine (mg/dL) and liver enzyme activities (GGT, GPT, GOT).

        3. Body mass index (kg/m2).

        4. Nutrients intake (g/day) from Food Frequency Questionnaire.

        5. Physical activity (MET-minutes per week) from International Physical Activity
           Questionnaire (IPAQ).
    

Intervention name(s): nutritional guidelines to promote healthy diet and increase fish intake
Intervention type(s): Behavioral
Intervention description(s): Nutritional guidelines based on the Mediterranean diet will be provided to both groups (gropu A and group B) through infographic material, recipes and menus.
Both groups will be guided to increase their fish consumption to 3 servings per week. Group A will do that through the consumption of fresh or frozen fish and group B through fresh, frozen and canned fish.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized nutritional intervention clinical trial of 2 parallel groups, in which 150 healthy adults between 18 and 65 years will be recruited.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: canned fish; red blood cell membrane lipidomics; omega-3 fatty acids