Cardiovascular DiseasesESISOPINCT02886169
Effectiveness of Sacha Inchi Supplementation on Postprandial Inflammation
A study testing High fat meal with Sacha Inchi and high saturated fat meal in people with Cardiovascular Diseases, run by Universidad Icesi at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 27 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- High fat meal with Sacha Inchi and high saturated fat meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged between 27 and 59 years.
- Give voluntary, signed informed consent.
- Group A: Be non-obese as defined as Waist circumference < 92 cm (Gallo, 2003)
- Group B: Be obese as defined as Waist circumference > 92 cm
- Physical inactivity (Adults aged 18-64 who do less than 150 minutes of moderate
- intensity aerobic physical activity throughout the week or less than 75 minutes of
- vigorous-intensity aerobic physical activity throughout the week or an equivalent
- combination of moderate- and vigorous-intensity activity).
Who cannot join
- Individuals with known gastrointestinal, renal or cardiovascular diseases, diabetes mellitus, fat intolerance, or those taking medications known to affect lipid metabolism or fat absorption.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
University of San Buenaventura
Cartagena, Departamento de Bolívar, 130010
About this study
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
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.
Read the 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:
- 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).
- 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).
- Follow up: During the week between the two interventions, participants follow the recommendations to maintain their usual diet.
- 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.
- 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- High fat meal with Sacha Inchi, high saturated fat meal
- Keywords
- Sacha Inchi, High-fat meal, Postprandial inflammatory responses
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat meal with Sacha InchiOther
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
high saturated fat mealOther
Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) and 125ml of coffee with 10g of sugar
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: High fat meal with Sacha Inchi |
| 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 Receives: Other: high saturated fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the different meal combinations on change from baseline plasma triglycerides (in mg/dL) at 1 and 4 hours after breakfast
Measured: 0, 1 and 4 hours after breakfast
Secondary outcomes (6)
Effect of the different meal combinations on change from baseline plasma Cholesterol (in mg/dL) at 1 and 4 hours after breakfast
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0, 1 and 4 hours after breakfast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Icesi
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de San Buenaventura
- Responsible party
- Sponsor
- Investigators
- Isabella Echeverri, Doctor, Principal investigator, Icesi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886169
- Sponsor's protocol ID
- CA051356
- Acronym
- ESISOPI
- Status last verified
- Apr 2019
- First submitted
- 11 Aug 2016
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02886169
- Acronym / sponsor ID
- ESISOPI / CA051356
- Conditions
- Cardiovascular Diseases
- Keywords
- Sacha Inchi, High-fat meal, Postprandial inflammatory responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad IcesiUniversity, hospital or other
- Collaborators
- Universidad de San Buenaventura
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- 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).
- Follow up: During the week between the two interventions, participants follow the recommendations to maintain their usual diet.
- 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.
- 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat meal with Sacha Inchi | Experimental | Other: High fat meal with Sacha InchiParticipants 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 | Other: high saturated fat mealParticipants will receive 100 g of bread with 70 g of butter (high saturated fat meal) and 125ml of coffee with 10g of sugar |
Who may qualify
- Ages
- 27 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men aged between 27 and 59 years.
- Give voluntary, signed informed consent.
- Group A: Be non-obese as defined as Waist circumference < 92 cm (Gallo, 2003)
- Group B: Be obese as defined as Waist circumference > 92 cm
- Physical inactivity (Adults aged 18-64 who do less than 150 minutes of moderate
Key exclusion criteria (1 listed)
- Individuals with known gastrointestinal, renal or cardiovascular diseases, diabetes mellitus, fat intolerance, or those taking medications known to affect lipid metabolism or fat absorption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High fat meal with Sacha InchiParticipants 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 | Other | High fat meal with Sacha Inchi |
| high saturated fat mealParticipants will receive 100 g of bread with 70 g of butter (high saturated fat meal) and 125ml of coffee with 10g of sugar | Other | unsupplemented group |
Primary outcome
Effect of the different meal combinations on change from baseline plasma triglycerides (in mg/dL) at 1 and 4 hours after breakfast
Time frame: 0, 1 and 4 hours after breakfast
6 secondary outcomes
Effect of the different meal combinations on change from baseline plasma Cholesterol (in mg/dL) at 1 and 4 hours after breakfast
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0, 1 and 4 hours after breakfast
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabella Echeverri, Doctor principal investigator
Icesi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fat meal with Sacha Inchi and high saturated fat meal in people with Cardiovascular Diseases, run by Universidad Icesi at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the different meal combinations on change from baseline plasma triglycerides (in mg/dL) at 1 and 4 hours after breakfast (time frame: 0, 1 and 4 hours after breakfast). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.