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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02886169 |
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Date of registration:
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11/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of Sacha Inchi Supplementation on Postprandial Inflammation
ESISOPI |
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Scientific title:
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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 |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02886169 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Colombia
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Contacts
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Name:
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Isabella Echeverri, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Icesi University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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).
Exclusion Criteria:
- Individuals with known gastrointestinal, renal or cardiovascular diseases, diabetes
mellitus, fat intolerance, or those taking medications known to affect lipid
metabolism or fat absorption.
Age minimum:
27 Years
Age maximum:
59 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Cardiovascular Diseases
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Intervention(s)
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Other: high saturated fat meal
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Other: High fat meal with Sacha Inchi
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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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]
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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]
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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]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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