Effect of Consumption of Chaya on Lipid Concentration and Antioxidant Status of Patients With Dyslipidemia
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      Currently, the changes generated in lifestyle, such as excessive consumption of saturated
      fats and refined carbohydrates, as well as the decrease in the intake of fiber, fruits,
      vegetables and antioxidants, as well as physical inactivity, have generated an increase in
      the prevalence of dyslipidemias. Dyslipidemias are a disorder of blood lipid and lipoprotein
      concentration, which increases the risk of developing atherosclerosis and cardiovascular
      diseases. In Mexico, the dyslipidemias are present in one in four Mexicans over 20 years old.
      However, in Yucatan increases this frequency increases due to one in three people suffer from
      dyslipidemia. Its prevalence is even higher in overweight subjects, diabetes and high blood
      pressure. Thus, it is important to search for strategies to reduce dyslipidemias, as well as
      the complications associated with them. The treatment and prevention of dyslipidemia is
      through dietary treatment, which may be accompanied by the consumption of foods that generate
      beneficial health effects due to the presence of bioactive compounds. Chaya (Cnidoscolus
      chayamansa) is a plant use in popular medicine to treat medicine in the treatment of chronic
      degenerative diseases. It contained different bioactive compounds such as flavonoids, vitamin
      C and polyphenols such as quercetin and kaempferol. Compounds that have been assigned various
      beneficial effects such as decreased triglyceride concentrations, cholesterol,
      malondialdehyde, C-Reactive protein, oxidized LDL, which are alterations that are present in
      dyslipidemia. Therefore, the consumption of this food could be an adequate strategy for
      subjects with dyslipidemia in Yucatan and Mexico due to the anti-inflammatory and antioxidant
      effects, and could reduce the risk of developing atherosclerosis and cardiovascular diseases.
    

Detailed description: 
      The protocol will be carried out in the Hospital Regional de Alta Especialidad de la
      Península de Yucatán (HRAEPY). It is quasi-experimental and it was proposed before and after
      study, the study will be consisting in 6 subsequent visits and a last visit to deliver
      results to the participant.

      In the pre-visit, the subjects will be evaluated to determine if they meet the inclusion
      criteria. They will be explained what the study consists of, the characteristics, the risks
      and the expected benefits after the intervention, they will be asked to read the consent
      letter, doubts will be clarified about it and if the participant agrees to be in the study
      the signature will be made of the consent letter.

      At the beginning and end will be taken two blood samples of 5 mL to each participant. One
      will be to obtain the serum and measure cholesterol-HDL, cholesterol-LDL, triglycerides,
      total cholesterol, glucose, antioxidant activity, malondialdehyde (MDA) and C-reactive
      protein. The second sample will be to the extraction of peripheral leukocyte blood
      mononuclear cells and determine the gene expression of antioxidants enzymes superoxide
      dismutase (SOD) and catalase (CAT). Blood pressure will be measured with a digital
      baumanometer while the participant will remain seated with the right arm uncovered. The
      measurement will be carried out 6 times, in intervals of 3 minutes. The first measurement
      will be discarded and the average of the remaining measurements will be reported. In the
      visits will bring to each participant an attachment to reported intake of the beverage.
      During the following ones it will always be questioned if there is any problem with the
      drinking the beverage of Chaya.

      At the end of the study, participants will be given the document with their results and will
      be given recommendations for weight control, dietary recommendations to improve lipid
      concentrations. They will refer to their doctor for follow-up with their laboratory results
      for their control.

      Description of the intervention

      Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be
      treated with a commercial brand disinfectant following the manufacturer's instructions for
      use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be
      placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7
      bottles will be delivered at each visit, which will be consumed during the week; participants
      will be instructed to keep the water refrigerated until it is consumed.
    

Intervention name(s): Chaya (Cnidoscolus chayamansa)
Intervention type(s): Dietary Supplement
Intervention description(s): Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed.
Intervention model: Single Group Assignment
Intervention model description: It is quasi-experimental and it was proposed before and after study, the study will be consisting of a pre-visit, 6 subsequent visits and a last visit to deliver results to the participant.
Masking: None (Open Label)
Primary purpose: Prevention