NCT02886169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

August 11, 2016

Last Update Submit

April 22, 2019

Conditions

Cardiovascular Diseases

Keywords

Sacha InchiHigh-fat mealPostprandial inflammatory responses

Outcome Measures

Primary Outcomes (1)

  • 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

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

    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

    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

  • +1 more secondary outcomes

Study Arms (2)

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

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

Other: high saturated fat meal

Interventions

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 fat meal with Sacha Inchi
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

unsupplemented group

Eligibility Criteria

Age27 Years - 59 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Individuals with known gastrointestinal, renal or cardiovascular diseases, diabetes mellitus, fat intolerance, or those taking medications known to affect lipid metabolism or fat absorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of San Buenaventura

Cartagena, Departamento de Bolívar, 130010, Colombia

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Isabella Echeverri, Doctor

    Icesi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

September 1, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

November 1, 2017

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

Locations

CO(1)