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| Name | Class |
|---|---|
| Universidad de San Buenaventura | OTHER |
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The postprandial state increases triglyceride-rich lipoproteins and lipopolysaccharide (LPS) levels, promoting cellular lipids accumulation, insulin resistance, increased inflammatory markers and the formation of foam cells, a situation that can have different effects depending the type of dietary fat and presence of metabolic conditions such as abdominal obesity and insulin resistance.
Given that the diet of the Colombian population is rich in saturated fats, and taking into consideration the general resistance to complex dietary changes, the purpose of this study is to evaluate whether Sacha Inchi oil supplementation of a high-fat meal is effective in reducing levels of biochemical markers of cardiovascular risk in adults with and without abdominal obesity.
Study population:
The sample will be taken from the population of administrative staff and professors of San Buenaventura University of Cartagena. They will be invited to participate adult men aged between 27 and 59 years with and without abdominal obesity.
Sample size:
To calculate the sample size, a statistical formula was used which allows the comparison of two paired means (repeated measures) in 2 groups. Since there may be a substantial degree of correlation between the magnitude of the baseline measurement and the subsequent, It is necessary to correct the formula for the correlation coefficient, that it was estimated, like the standard deviation (SD), from previous experiences.
The minimum number of subjects (n) for each study group was defined according to the estimate for similar studies in design and study variables, considering as main study variable the levels of triglycerides. Considering the following values: Za = 1,64; Z = 1,28; Mde - Mdc = expected minimum difference = 48; Standard deviation of the primary endpoint = 78,6 and a correlation coefficient of 0,6. With these values the n in both groups was 18 subjects. 21 participants with abdominal obesity and 21 without abdominal obesity will be included providing a 20% of losses.
Method:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High fat meal with Sacha Inchi | Experimental | Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) added with 15ml of Sacha Inchi oil and 125ml of coffee with 10g of sugar |
|
| unsupplemented group | Placebo Comparator | Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) and 125ml of coffee with 10g of sugar |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High fat meal with Sacha Inchi | Other | Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) added with 15ml of Sacha Inchi oil and 125ml of coffee with 10g of sugar |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the different meal combinations on change from baseline plasma triglycerides (in mg/dL) at 1 and 4 hours after breakfast | 0, 1 and 4 hours after breakfast |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the different meal combinations on change from baseline plasma Cholesterol (in mg/dL) at 1 and 4 hours after breakfast | 0, 1 and 4 hours after breakfast | |
| Effect of the different meal combinations on change from baseline plasma High density lipoprotein cholesterol (HDL-Cholesterol , in mg/dL) at 1 and 4 hours after breakfast |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabella Echeverri, Doctor | Icesi University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of San Buenaventura | Cartagena | Departamento de BolÃvar | 130010 | Colombia |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| high saturated fat meal | Other | Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) and 125ml of coffee with 10g of sugar |
|
| 0, 1 and 4 hours after breakfast |
| Effect of the different meal combinations on change from baseline plasma Glucose (in mg/dL) at 1 and 4 hours | 0, 1 and 4 hours after breakfast |
| Effect of the different meal combinations on change from baseline plasma insulin (in uIU/mL) at 1 and 4 hours | 0, 1 and 4 hours after breakfast |
| Effect of the different meal combinations on change from baseline plasma Homeostatic model assessment (HOMA index) (in uIU/mL) at 1 and 4 hours | 0, 1 and 4 hours after breakfast |
| Effect of the different meal combinations on change from baseline plasma Lipopolysaccharides (EU/mL) at 1 and 4 hours | 0, 1 and 4 hours after breakfast |