Single-blind, double-blind, controlled, randomized clinical trial of two parallel branches depending on the product consumed (experimental product and placebo product) and single-center with the objective of evaluating the effect of the investigational product on cardiovascular risk reduction.
Subjects who meet the selection criteria will make a total of two visits to the research laboratory and will carry out the tests established in the protocol. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
The consumption time was 56 days. Consumed 100 grams daily to consume during the day.
Catholic University of Murcia
Murcia, Spain
Total Cholesterol
Lipidic profile, measured in mg/dl
Time frame: It is measured on an empty stomach, change after 56 days of consumption.
LDL - Cholesterol
Lipidic profile, measured in mg/dl
Time frame: It is measured on an empty stomach, change after 56 days of consumption.
HDL - Cholesterol
Lipidic profile, measured in mg/dl
Time frame: It is measured on an empty stomach, change after 56 days of consumption.
Triglycerides
Lipidic profile, measured in mg/dl
Time frame: It is measured on an empty stomach, change after 56 days of consumption.
Assessing a change of blood pressure
blood pressure is measured with a holter
Time frame: Blood pressure measurements will be taken with a Holter monitor on two separate occasions and for 24 hours each day. Measurements were made at baseline and after 56 days of product consumption. Systolic and diastolic blood pressure will be measured
Blood glucose
Glycidic analysis, measured in mg/dL
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Glycosylated hemoglobin (HBA1c)
Glycidic analysis, measured in %
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
malondialdehyde (MDA)
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oxidative damage, measured in ng/ml
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Oxidized LDL
oxidative damage, measured in pg/mL
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Superoxide Dismutase (SOD)
antioxidant defense, measured in pg/mL
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Interleukin-6 (IL-6)
Inflammation, measured in pg/mL
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Proteins C Reactive (PCR)
Inflammation, measured in mg/l
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Fat mass
Bioimpedance, in Kg.
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Muscle mass
Bioimpedance, in Kg.
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Body mass index
Bioimpedance, in Kg/m2.
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Percentage of fat mass
Bioimpedance, in %.
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Control of dietary intake
Diet source
Time frame: A nutritional registry will be carried out. The nutritional intake of three days in two periods will be collected. One record at the beginning and another at the end, that is, six days.
Physical Activity Questionnaire
Measured with the questionnaire Global Questionnaire on Physical Activity
Time frame: It is measured before and after the consumption time (56 days).
Liver safety variables
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).