Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 11:00 AM
Study NCT ID:
NCT02886169
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2016-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Sacha Inchi Supplementation on Postprandial Inflammation
Sponsor:
Universidad Icesi
Organization:
Study Overview
Official Title:
Effect of Supplementation of a High-fat Meal With Sacha Inchi Oil on Postprandial Metabolic and Inflammatory Responses in Adults With Low Physical Activity and Without Abdominal Obesity
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESISOPI
Brief Summary:
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.
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.
Detailed Description:
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:
1. Catchment: The initial selection of potential participants in the study will be made from the review of the lists of administrators and professors at the University of San Buenaventura in Cartagena. From this list will be selected randomly using random numbers of Excel program a total of 100 participants. People who meet the inclusion criteria will be informed of the study and invited to participate by reading and signing informed consent. They will conduct a survey and anthropometric measurements were taken (weight, height, waist circumference).
2. Intervention: Participants will be cited on two occasions, one week apart, in the morning and after fasting for 12 hours, for breakfast and perform blood sampling. Before the intervention the order in which they will receive breakfast (AB or BA) will be drawn. On each occasion three blood samples were taken per participant (fasting, 1 and 4 hours postprandial).
3. Follow up: During the week between the two interventions, participants follow the recommendations to maintain their usual diet.
4. Sampling: The samples will be taken by a clinical laboratory assistant in EDTA tubes and dry tubes. At the laboratory, plasma and serum will be separated by centrifugation. The samples will be stored at -20 ° C until quantification of the variables of interest.
5. Quantification of biochemical variables: lipopolysaccharide (LPS) will be quantified in plasma by the Limulus amebocyte lysate test. The concentrations of glucose, total cholesterol and triglycerides will be quantified by spectrophotometric enzyme assays. Insulin will be measured by immunoassay.
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:
1. Catchment: The initial selection of potential participants in the study will be made from the review of the lists of administrators and professors at the University of San Buenaventura in Cartagena. From this list will be selected randomly using random numbers of Excel program a total of 100 participants. People who meet the inclusion criteria will be informed of the study and invited to participate by reading and signing informed consent. They will conduct a survey and anthropometric measurements were taken (weight, height, waist circumference).
2. Intervention: Participants will be cited on two occasions, one week apart, in the morning and after fasting for 12 hours, for breakfast and perform blood sampling. Before the intervention the order in which they will receive breakfast (AB or BA) will be drawn. On each occasion three blood samples were taken per participant (fasting, 1 and 4 hours postprandial).
3. Follow up: During the week between the two interventions, participants follow the recommendations to maintain their usual diet.
4. Sampling: The samples will be taken by a clinical laboratory assistant in EDTA tubes and dry tubes. At the laboratory, plasma and serum will be separated by centrifugation. The samples will be stored at -20 ° C until quantification of the variables of interest.
5. Quantification of biochemical variables: lipopolysaccharide (LPS) will be quantified in plasma by the Limulus amebocyte lysate test. The concentrations of glucose, total cholesterol and triglycerides will be quantified by spectrophotometric enzyme assays. Insulin will be measured by immunoassay.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: