randomized, placebo-controlled clinical trial, with two parallel branches whose objective is to evaluate the efficacy of the product investigated on blood pressure and fat mass of subjects without pharmacotherapy.
The subjects that meet the selection criteria will make a total of five visits to the research laboratory and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Consumption of the product under study for 84 days, plecebo or experimental product
Catholic University of Murcia
Murcia, Spain
Total fat mass
Dual X-ray absorptiometry (DEXA), measured in grams.
Time frame: From baseline to 84 days
Fat mass in torso
Dual X-ray absorptiometry (DEXA), measured in grams.
Time frame: From baseline to 84 days
Fat mass in lower limbs
Dual X-ray absorptiometry (DEXA), measured in grams.
Time frame: From baseline to 84 days
Fat mass
Bioimpedancetry, in grams.
Time frame: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.
Muscle mass
Bioimpedancetry, in grams.
Time frame: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.
Percentage of fat mass
Bioimpedancetry.
Time frame: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For this we will use a TANITA.
blood samples: Glucidal metabolism and lipid metabolism.
BASIC GLUCEMIA, TOTAL CHOLESTEROL, HDL CHOLESTEROL, LDL , CHOLESTEROL, TRIGLICERIDS, GLICATED HEMOGLOBIN. It was measured in milligrams per deciliter
Time frame: Time Frame: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use.
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Subjective sensation of product consumption
5-point hedonic scale. There are five points, being 1 I do not like and 5 I like it a lot. A scale will be passed through paper.
Time frame: Time Frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.
physical activity
MEASURED WITH ACTIGRAPH wGT3X-BT
Time frame: Time Frame: An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study
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: Hematological samples were taken before (day 0) and after consumption of the product (day 84) both in the control group and in the experimental group.
Weight
measured in Kg.
Time frame: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For these determinations we will use a scale (SECA).
Height
Measured in cm.
Time frame: Time Frame: A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days. For these determinations we will use a scale (SECA).