High Blood Pressure, Overweight and Obesity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTdietary supplement consumption
Consumption of the product under study for 84 days, plecebo or experimental product
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects of both sexes with age between 18-65 years. * Subjects with a body mass index greater than 25 and less than 35. * Volunteers capable of understanding the clinical study and willing to comply with the procedures and requirements of the study.
Exclusion criteria
* Subjects under treatment that may affect body weight. * Subjects with acute diseases. * Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathology or malignant tumor disease. * Subjects undergoing major surgery in the last 3 months. * Subjects who quit smoking in the last 6 months or who intend to quit during the study. * Subjects with allergies or eating disorders. * Volunteers who are participating in another study that includes blood draws or dietary intervention. * Pregnant or breastfeeding woman. * Subjects whose condition does not make them eligible for the study, according to the researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total fat mass | From baseline to 84 days | Dual X-ray absorptiometry (DEXA), measured in grams. |
| Fat mass in torso | From baseline to 84 days | Dual X-ray absorptiometry (DEXA), measured in grams. |
| Fat mass in lower limbs | From baseline to 84 days | Dual X-ray absorptiometry (DEXA), measured in grams. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood samples: Glucidal metabolism and lipid metabolism. | 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. | BASIC GLUCEMIA, TOTAL CHOLESTEROL, HDL CHOLESTEROL, LDL , CHOLESTEROL, TRIGLICERIDS, GLICATED HEMOGLOBIN. It was measured in milligrams per deciliter |
| Subjective sensation of product consumption | Time Frame: Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study. | 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. |
| physical activity | 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 | MEASURED WITH ACTIGRAPH wGT3X-BT |
| Fat mass | 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. | Bioimpedancetry, in grams. |
| Weight | 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). | measured in Kg. |
| Height | 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). | Measured in cm. |
| liver safety variables | 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. | 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) |
| Muscle mass | 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. | Bioimpedancetry, in grams. |
| Percentage of fat mass | 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. | Bioimpedancetry. |
Countries
Spain
Outcome results
None listed