- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04738929
Comparing EVCO and EVOO
February 3, 2021 updated by: Ziyaerokaymetin, Ankara City Hospital Bilkent
Comparing Acute Effects of Extra Virgin Coconut Oil and Extra Virgin Olive Oil Consumption on Appetite and Food Intake in Normal Weight and Obese Male Subjects
The aim of this study is to compare acute effects of consuming extra virgin coconut oil (EVCO) as a source of medium chain fatty acids and extra virgin olive oil (EVOO) as a source of long chain fatty acids in normal weight and obese subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Twenty male subjects (10 normal weight; 10 obese) consumed breakfast meals containing skimmed milk, fat-free white cheese, bread and EVCO (25 g) or EVOO (25 g).
Visual analog scale evaluations, resting metabolic rate measurements and selected blood parameters analysis (glucose, triglyceride, insulin and plasma peptide YY) were performed before and after the test breakfast meals.
In addition, energy intakes were evaluated by ad libitum lunch meal at 180 min.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Presidency of Republic of Turkey Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Metabolically healthy
- Aged 19-40 years
- Normal weight (BMI=18.5-24.9 kg/m²) and obese men (BMI=30-34.99 kg/m²)
Exclusion Criteria:
- smoking,
- alcohol consumption,
- weight gain/loss recently (> %5, in three months),
- any genetic and metabolic diseases,
- any food allergy/intolerance,
- any medication,
- restrained eating habits.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Normal weight
Normal weight subjects (BMI=18.5-25)
|
Subjects consumed standard breakfast meals containing "extra virgin coconut oil" or "extra virgin olive oil"
|
|
Experimental: Obese
Obese subjects (BMI=30-34.99)
|
Subjects consumed standard breakfast meals containing "extra virgin coconut oil" or "extra virgin olive oil"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy expenditure change
Time Frame: 0, 60, 120, 180 minutes
|
kcal
|
0, 60, 120, 180 minutes
|
|
Subjective appetite feelings change
Time Frame: 0, 30, 60, 120, 180 minutes
|
visual analogue scales rating (0-10 cm)
|
0, 30, 60, 120, 180 minutes
|
|
glucose change
Time Frame: 0, 30, 60, 120, 180 minutes
|
mg/dl
|
0, 30, 60, 120, 180 minutes
|
|
insulin change
Time Frame: 0, 30, 60, 120, 180 minutes
|
mU/L
|
0, 30, 60, 120, 180 minutes
|
|
peptide YY change
Time Frame: 0, 30, 60, 120, 180 minutes
|
pg/dl
|
0, 30, 60, 120, 180 minutes
|
|
triglycerides change
Time Frame: 0, 30, 60, 120, 180 minutes
|
mg/dl
|
0, 30, 60, 120, 180 minutes
|
|
Ad libitum energy intake
Time Frame: 180 minute
|
kcal
|
180 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ziya Erokay Metin, Dr., Ankara City Hospital Bilkent
- Study Chair: Pelin Bilgiç, Assoc. Prof., Hacettepe University
- Study Chair: Mercan Merve Tengilimoğlu Metin, Assis. Prof., Hacettepe University
- Study Chair: Muzaffer Akkoca, Assoc. Prof., Saglik Bilimleri Universitesi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2019
Primary Completion (Actual)
June 3, 2019
Study Completion (Actual)
June 3, 2019
Study Registration Dates
First Submitted
January 20, 2021
First Submitted That Met QC Criteria
February 3, 2021
First Posted (Actual)
February 4, 2021
Study Record Updates
Last Update Posted (Actual)
February 4, 2021
Last Update Submitted That Met QC Criteria
February 3, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EVCO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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