- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05208346
Effects of Canola Oil and Coconut Oil on Postprandial Metabolism in Older Adults With Increased Cardiometabolic Risk
November 2, 2023 updated by: Prof. Dr. Sarah Egert, University of Bonn
Acute Effects of Canola Oil Compared With Coconut Oil on Postprandial Metabolism in Women and Men With Increased Risk for Cardiometabolic Diseases
The aim of this study is to investigate the postprandial effects of fat content and fatty acid composition of mixed meals on parameters associated with cardiometabolic diseases.
Therefore, older subjects with increased risk of cardiometabolic diseases consume 4 mixed meals with 25 or 50 g of either canola or coconut oil.
In a postprandial period of 6 hours, outcomes associated with cardiometabolic risk (e.g., triglycerides) are analyzed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In a crossover design, 30 older men and women with increased risk of cardiometabolic diseases consume 4 mixed meals, enriched with either 25 or 50 g canola or coconut oil.
During a postprandial period of 6 hours, parameters of lipid metabolism (e.g., plasma triglycerides), glucose metabolism (e.g., plasma glucose, serum insulin), as well as markers of inflammation (e.g., IL-6), vascular system (e.g., pulse wave velocity) and antioxidant system (e.g., trolox equivalent antioxidative capacity) are analyzed.
Furthermore, fatty acid profile, neuropsychologic parameters (e.g., appetite) and satiety-associated hormones (e.g., Ghrelin) are assessed.
Each intervention arm will be separated by a washout period of about 14 days.
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
-
Bonn, Germany, 53115
- University of Bonn
-
-
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
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- BMI: 27 - 34,9 kg/m2
- Waist circumference: women ≥ 80 cm, men ≥ 94 cm
- At least two of the following criteria of metabolic syndrome:
Fasting triglycerides in serum: ≥ 150 mg/dl Fasting HDL-Cholesterol in serum: women < 50 mg/dl, men < 40 mg/dl Systolic blood pressure: ≥ 130 mmHg, diastolic blood pressure: ≥ 85 mmHg Fasting glucose in plasma: ≥ 100 mg/dL
Exclusion Criteria:
- Smoking
- Diseases that may impact outcome measures (e.g., thyroid diseases, insulin-dependent diabetes mellitus, impaired renal function, tumors, anemia)
- Intake of immunosuppressives or supplements (e.g., fish oil)
- Participation in another study
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Canola oil high-fat
Participants randomized to receive a mixed meal with 50 g canola oil
|
Mixed meals enriched with either 25 or 50 g of canola or coconut oil
|
Experimental: Coconut oil high-fat
Participants randomized to receive a mixed meal with 50 g coconut oil
|
Mixed meals enriched with either 25 or 50 g of canola or coconut oil
|
Experimental: Canola oil low-fat
Participants randomized to receive a mixed meal with 25 g canola oil
|
Mixed meals enriched with either 25 or 50 g of canola or coconut oil
|
Experimental: Coconut oil low-fat
Participants randomized to receive a mixed meal with 25 g coconut oil
|
Mixed meals enriched with either 25 or 50 g of canola or coconut oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parameters of lipid metabolism in blood I
Time Frame: Postprandial period of 6 hours
|
Measurement of triglycerides (mg/dl)
|
Postprandial period of 6 hours
|
Parameters of lipid metabolism in blood II
Time Frame: Postprandial period of 6 hours
|
Measurement of total cholesterol (mg/dl)
|
Postprandial period of 6 hours
|
Parameters of lipid metabolism in blood III
Time Frame: Postprandial period of 6 hours
|
Measurement of LDL cholesterol (mg/dl)
|
Postprandial period of 6 hours
|
Parameters of lipid metabolism in blood IV
Time Frame: Postprandial period of 6 hours
|
Measurement of HDL cholesterol (mg/dl)
|
Postprandial period of 6 hours
|
Parameters of lipid metabolism in blood VI
Time Frame: Postprandial period of 6 hours
|
Measurement of free fatty acids (mmol/L)
|
Postprandial period of 6 hours
|
Parameters of glucose metabolism in blood I
Time Frame: Postprandial period of 6 hours
|
Measurement of glucose (mg/dl)
|
Postprandial period of 6 hours
|
Parameters of glucose metabolism in blood II
Time Frame: Postprandial period of 6 hours
|
Measurement of insulin (nmol/L)
|
Postprandial period of 6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial inflammation
Time Frame: Postprandial period of 6 hours
|
Measurement of parameters of inflammation in blood (e.g., IL-6 in pg/ml)
|
Postprandial period of 6 hours
|
Antioxidant system
Time Frame: Postprandial period of 6 hours
|
Measurement of parameters of antioxidant system in blood (e.g., TEAC in mmol Trolox equivalents/L)
|
Postprandial period of 6 hours
|
Fatty acid profile
Time Frame: Postprandial period of 6 hours
|
Analysis of fatty acid profile in serum (e.g., alpha-linolenic acid in µmol/L)
|
Postprandial period of 6 hours
|
Assessment of hunger and satiety
Time Frame: Postprandial period of 6 hours
|
Assessment via visual analogue scales (e.g., 0 = not hungry at all, 10 = very hungry)
|
Postprandial period of 6 hours
|
Assessment of attention and memory
Time Frame: Postprandial period of 6 hours
|
Assessment via validated neuropsychological questionnaires (paper-pencil)
|
Postprandial period of 6 hours
|
Postprandial endothelial function
Time Frame: Postprandial period of 6 hours
|
Assessment via the Vicorder device (e.g., measurement of pulse wave velocity in m/s)
|
Postprandial period of 6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah Egert, Prof. Dr., University of Bonn
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)
March 9, 2022
Primary Completion (Actual)
October 18, 2022
Study Completion (Actual)
October 18, 2022
Study Registration Dates
First Submitted
November 23, 2021
First Submitted That Met QC Criteria
January 12, 2022
First Posted (Actual)
January 26, 2022
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 2, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 528/191
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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