Effectiveness of Sacha Inchi Supplementation on Postprandial Inflammation
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The postprandial state increases triglyceride-rich lipoproteins and lipopolysaccharide (LPS)
      levels, promoting cellular lipids accumulation, insulin resistance, increased inflammatory
      markers and the formation of foam cells, a situation that can have different effects
      depending the type of dietary fat and presence of metabolic conditions such as abdominal
      obesity and insulin resistance.

      Given that the diet of the Colombian population is rich in saturated fats, and taking into
      consideration the general resistance to complex dietary changes, the purpose of this study is
      to evaluate whether Sacha Inchi oil supplementation of a high-fat meal is effective in
      reducing levels of biochemical markers of cardiovascular risk in adults with and without
      abdominal obesity.
    

Detailed description: 
      Study population:

      The sample will be taken from the population of administrative staff and professors of San
      Buenaventura University of Cartagena. They will be invited to participate adult men aged
      between 27 and 59 years with and without abdominal obesity.

      Sample size:

      To calculate the sample size, a statistical formula was used which allows the comparison of
      two paired means (repeated measures) in 2 groups. Since there may be a substantial degree of
      correlation between the magnitude of the baseline measurement and the subsequent, It is
      necessary to correct the formula for the correlation coefficient, that it was estimated, like
      the standard deviation (SD), from previous experiences.

      The minimum number of subjects (n) for each study group was defined according to the estimate
      for similar studies in design and study variables, considering as main study variable the
      levels of triglycerides. Considering the following values: Za = 1,64; Z = 1,28; Mde - Mdc =
      expected minimum difference = 48; Standard deviation of the primary endpoint = 78,6 and a
      correlation coefficient of 0,6. With these values the n in both groups was 18 subjects. 21
      participants with abdominal obesity and 21 without abdominal obesity will be included
      providing a 20% of losses.

      Method:

        1. Catchment: The initial selection of potential participants in the study will be made
           from the review of the lists of administrators and professors at the University of San
           Buenaventura in Cartagena. From this list will be selected randomly using random numbers
           of Excel program a total of 100 participants. People who meet the inclusion criteria
           will be informed of the study and invited to participate by reading and signing informed
           consent. They will conduct a survey and anthropometric measurements were taken (weight,
           height, waist circumference).

        2. Intervention: Participants will be cited on two occasions, one week apart, in the
           morning and after fasting for 12 hours, for breakfast and perform blood sampling. Before
           the intervention the order in which they will receive breakfast (AB or BA) will be
           drawn. On each occasion three blood samples were taken per participant (fasting, 1 and 4
           hours postprandial).

        3. Follow up: During the week between the two interventions, participants follow the
           recommendations to maintain their usual diet.

        4. Sampling: The samples will be taken by a clinical laboratory assistant in EDTA tubes and
           dry tubes. At the laboratory, plasma and serum will be separated by centrifugation. The
           samples will be stored at -20 ° C until quantification of the variables of interest.

        5. Quantification of biochemical variables: lipopolysaccharide (LPS) will be quantified in
           plasma by the Limulus amebocyte lysate test. The concentrations of glucose, total
           cholesterol and triglycerides will be quantified by spectrophotometric enzyme assays.
           Insulin will be measured by immunoassay.
    

Intervention name(s): High fat meal with Sacha Inchi; high saturated fat meal
Intervention type(s): Other; Other
Intervention description(s): Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) added with 15ml of Sacha Inchi oil and 125ml of coffee with 10g of sugar; Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) and 125ml of coffee with 10g of sugar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Sacha Inchi; High-fat meal; Postprandial inflammatory responses