Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Consumption of antioxidant boiled ham, 100 grams daily to consume during the day. Consumption time: 8 weeks. |
|
| control group Placebo | Placebo Comparator | Consumption of extra boiled ham, 100 grams daily to consume during the day. Consumption time: 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement consumption | Dietary Supplement | The consumption time was 56 days. Consumed 100 grams daily to consume during the day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol | Lipidic profile, measured in mg/dl | It is measured on an empty stomach, change after 56 days of consumption. |
| LDL - Cholesterol | Lipidic profile, measured in mg/dl | It is measured on an empty stomach, change after 56 days of consumption. |
| HDL - Cholesterol | Lipidic profile, measured in mg/dl | It is measured on an empty stomach, change after 56 days of consumption. |
| Triglycerides | Lipidic profile, measured in mg/dl | It is measured on an empty stomach, change after 56 days of consumption. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing a change of blood pressure | blood pressure is measured with a holter | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Murcia | Murcia | 30107 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Blood glucose |
Glycidic analysis, measured in mg/dL |
| It is measured on an empty stomach, before and after the consumption time (56 days). |
| Glycosylated hemoglobin (HBA1c) | Glycidic analysis, measured in % | It is measured on an empty stomach, before and after the consumption time (56 days). |
| malondialdehyde (MDA) | oxidative damage, measured in ng/ml | It is measured on an empty stomach, before and after the consumption time (56 days). |
| Oxidized LDL | oxidative damage, measured in pg/mL | It is measured on an empty stomach, before and after the consumption time (56 days). |
| Superoxide Dismutase (SOD) | antioxidant defense, measured in pg/mL | It is measured on an empty stomach, before and after the consumption time (56 days). |
| Interleukin-6 (IL-6) | Inflammation, measured in pg/mL | It is measured on an empty stomach, before and after the consumption time (56 days). |
| Proteins C Reactive (PCR) | Inflammation, measured in mg/l | It is measured on an empty stomach, before and after the consumption time (56 days). |
| Fat mass | Bioimpedance, in Kg. | It is measured on an empty stomach, before and after the consumption time (56 days). |
| Muscle mass | Bioimpedance, in Kg. | It is measured on an empty stomach, before and after the consumption time (56 days). |
| Body mass index | Bioimpedance, in Kg/m2. | It is measured on an empty stomach, before and after the consumption time (56 days). |
| Percentage of fat mass | Bioimpedance, in %. | It is measured on an empty stomach, before and after the consumption time (56 days). |
| Control of dietary intake | Diet source | 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 | 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) | It is measured on an empty stomach, before and after the consumption time (56 days). |