Effect of an Antiinflammatory Diet on Postprandial Gene Expression of Mononuclear Cells of Adult Obese Women
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity is one of the major health problems worldwide. The consumption of healthy-dietary
      patterns can be difficult in some countries due to the availability of certain foods.
      Suggestion of alternative foods could be a necessity. The purpose of this study was to
      evaluate the effect of a dietary pattern consisting of fruit, avocado, whole-grains and trout
      (FAWGT) on postprandial gene expression, insulinemia and lipemia in Colombian obese people.
    

Detailed description: 
      A randomized controlled crossover study was conducted. Volunteers underwent to two dietary
      models for 8 weeks each, including a 2 weeks washout diet between them. The order in which
      they started the interventions was randomized following a computerized assignment list using
      Excel software (Microsoft Office 2015, Excel 2013).

      The primary endpoint was the postprandial gene expression of nuclear factor kappa B subunit 1
      (NFKB1) gene. Based on previous studies , 20 individuals had to be studied to detect a 0.2
      difference in the expression of the NKKB1 gene between diets with 0.05 significance level and
      80 percentage power (type II error Z 0.2), assuming a 10 percentage drop-out rate.

      The recruitment of participants was carried out according to the following steps:

        1. Review of clinical histories of patients diagnosed with obesity, according to their Body
           Mass Index, ascribed to the chronic non-communicable diseases program of the Clinica
           Comfamiliar Risaralda in the city of Pereira Colombia.

        2. Telephone call to invite the participants who met the inclusion criteria to participate
           in the study.

        3. Appointment prior to the start of the study to take a blood sample to corroborate the
           inclusion criteria. With this sample the following tests were performed: blood glucose,
           lipid profile, thyroid stimulating hormone (TSH), C-reactive protein ( and complete
           blood count.

      This process was carried out by personnel not involved in the research. The results obtained
      were compared with the clinical history.

      The diets followed during the intervention periods were: (1) a diet consisting mainly of the
      consumption of fruit, avocado and other vegetables, whole grains and trout typical of the
      colombian coffee region (FAWGT) (experimental diet), and (2) the usual diet consumed by the
      participants in their normal lifestyle (UD).

      At the beginning of the dietary intervention period, each participant was given an
      individualized food guide containing the suggested food group and portions, with a wide
      variety of foods allowed for greater adherence to the diet. In addition, specific times for
      consumption of the foods and precise instructions for the dietary intervention were given. In
      addition, the subjects were given a talk advising them how to quantify the portions, which
      would later be converted into grams according to the procedure described

      The food portions were standardized with all the participants using synthetic models, adapted
      according to the Colombian nutritional guidelines, so that they could provide a more accurate
      report of the portions consumed during the intervention. In addition, a postprandial studies
      were carried out at the beginning of the study (pre-intervention) and another after 8 weeks
      of dietary intervention (post-intervention).

      The participants were given an appointment at the health center at 7.00 am, after at least 12
      hours of fasting and a 5 day abstinence from alcohol. They consumed a breakfast based on the
      same composition of the diet in which they were randomized for the dietary intervention
      period. The blood samples were obtained by veni-puncture at baseline and 4 hours after
      breakfast. During the postprandial period, the participants did not consume any more food,
      although they were allowed to drink water. The breakfasts were composed of the following
      foods: FAWGT diet; whole-grain arepa (with unrefined corn flour), cheese, oats, granadilla,
      mango, linseed, nuts, almonds, peanuts and yogurt. Usual diet; egg, cheese, butter, whole
      milk, traditional white arepa (with re-fined corn flour), traditional buñuelo (made from
      wheat flour with cheese), coffee and sugar.

      Before starting the dietary intervention period (Pre-intervention), at the midpoint of the
      study (week 4) and at the end (week 8), all the participants completed three 24-hour recalls
      (2 non-consecutive weekdays and one weekend day) to obtain information about food,
      ingredients and preparations consumed in the same units of measurement (grams).

      In addition, a weekly telephone call was made to answer any questions relating to the diet
      (recipes, menu and quantities) and to motivate adherence to the assigned dietary model.

      Moreover, in week four of each intervention, the participants attended the hospital for an
      interview with the main researcher in order to take anthropometric measurements, evaluate the
      follow-up of the dietary instructions and answer any questions that may have arisen during
      the intervention, and motivate them to continue with the study. To collect the information on
      food consumption, formats and questionnaires previously published by the research group were
      used.
    

Intervention name(s): FAWGT diet; Usual diet (UD)
Intervention type(s): Other; Other
Intervention description(s): Composed of 15% protein, 55% CH and 30% fat of which < 10% was SFA, 14% MUFA and 6% PUFA in the overall total caloric content.; Consisted of 16% protein, 54% carbohydrates (CH) and 30% fat of which 15% was saturated fat (SFA), 10% monounsaturated fat (MUFA) and 5% polyunsaturated fat (PUFA)in relation to the total caloric content
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity; Diet; Postprandial state; Gene expression; Inflammation; Lipemia; Insulinemia