Effect of an Atlantic Diet on Anthropometric Indices and Serum Lipid Profile
Condition: Cardiovascular Disease; Adiposity; Hypercholesterolemia
MeSH terms: Cardiovascular Diseases; Hypercholesterolemia
Study type: Interventional

Summary: 
      BACKGROUND:

      The Southern European Atlantic Diet (SEAD) is the traditional diet of Northern Portugal and
      Galicia, a region in northwest Spain. The SEAD has been associated with a lower risk of
      non-fatal acute myocardial infarction. Possible mechanisms of this association may be related
      with a lower concentration of markers of inflammation and with reduced triglycerides,
      insulin, insulin resistance, and systolic blood pressure.

      Aim: To evaluate the effect of an Atlantic Diet on i) lipid profile, ii) markers of
      inflammation, and iii) anthropometric indices in a population-based study

      METHODS:

      This is a non-pharmacological clinical trial study which is performed on a family-oriented
      basis. 250 families (~ 750 children and adults, older than 3 years) were selected to
      participate in the study and randomized into Atlantic Diet (AD) (n=125 families) and control
      (n=125 families) groups. The AD groups participate in a diet program 1 day a month for 3
      months in 120-minute diet sessions and freely receive AD food, characterized by a high intake
      of vegetables, cheese, olive oil, mussels and by wine consumption during meals. Control group
      subjects do not participate in any regular diet activity during this period and did not
      receive additional food. Exclusion criteria are alcoholism, lipid treatment, dementia, and
      terminal disease.

      Weight, BMI, waist circumference (WC), skin folds, nutrient intake from 3-day recalls, food
      frequency questionnaire, physical activity, blood pressure, metabolic function (fasting blood
      glucose, HBA1c, insulin resistance and lipid profile), and inflammation markers (c-reactive
      protein, interleukin 6 and tumor necrosis factor-alpha) are measured at baseline, 3 and 6
      months. Mixed effect models will be performed to assess the significance of changes in the
      cardiometabolic parameters.

      The primary end point is the change in lipid profile compared with baseline and the control
      group arm at the end of Month 6. The secondary exploratory end points were change in
      anthropometric indices and inflammation markers at Month 6.
    

Detailed description: 
      The intervention period lasted 6 months. At the baseline visit all AD subjects received
      information on the Atlantic diet and how to follow it; the nutritionists' messages were
      adapted to the clinical condition of each subject, his/her preferences, needs, beliefs and
      culture. Special care was taken with patients who were obese, had diabetes or who had high
      blood cholesterol; conflicts with recommendations made by subjects' own doctors or
      nutritionists were avoided. All questionnaires (see below) were filled out in the presence of
      the nutritionists, except for 3-day food records which the subjects handed in completed. The
      latter were reviewed in the presence of the subjects in order to correct any errors or add
      missing information. At the 3 and 6 month visits, the nutritionists reminded the subjects
      about the Atlantic diet and the helped them complete their questionnaires.

      Foods were provided to the families of the AD group. Wine was provided only to non-tee-total
      adults. Food packages were delivered every three weeks to the family home. The food included
      in the package was calculated for the total number of family members, even if not all were
      taking part in the study. At delivery, a form was filled in to verify that the previous lot
      of food had been consumed, and to note any problems.
    

Intervention name(s): Diet
Intervention type(s): Behavioral
Intervention description(s): diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment