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Effects of Canola Oil and Coconut Oil on Postprandial Metabolism in Older Adults With Increased Cardiometabolic Risk

Primary Purpose

Cardiovascular Diseases, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mixed meals
Sponsored by
University of Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiovascular Diseases focused on measuring Postprandial metabolic events

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Bonn

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Canola oil high-fat

Coconut oil high-fat

Canola oil low-fat

Coconut oil low-fat

Arm Description

Participants randomized to receive a mixed meal with 50 g canola oil

Participants randomized to receive a mixed meal with 50 g coconut oil

Participants randomized to receive a mixed meal with 25 g canola oil

Participants randomized to receive a mixed meal with 25 g coconut oil

Outcomes

Primary Outcome Measures

Parameters of lipid metabolism in blood I
Measurement of triglycerides (mg/dl)
Parameters of lipid metabolism in blood II
Measurement of total cholesterol (mg/dl)
Parameters of lipid metabolism in blood III
Measurement of LDL cholesterol (mg/dl)
Parameters of lipid metabolism in blood IV
Measurement of HDL cholesterol (mg/dl)
Parameters of lipid metabolism in blood V
Measurement of ApoB48 (g/L)
Parameters of lipid metabolism in blood VI
Measurement of free fatty acids (mmol/L)
Parameters of glucose metabolism in blood I
Measurement of glucose (mg/dl)
Parameters of glucose metabolism in blood II
Measurement of insulin (nmol/L)

Secondary Outcome Measures

Assessment of hunger
Assessment of hunger via visual analogue scale (0 = not hungry at all, 10 = very hungry)
Assessment of attention
Assessment of attention via validated neuropsychological questionnaires (paper-pencil)
Postprandial endothelial function
Performance of pulse wave analysis with the Vicorder device (measurement of pulse wave velocity in m/s)
Parameters of endothelial function in blood
Measurement of blood parameters of endothelial function (e.g., ADMA in µmol/L)
Postprandial inflammation
Measurement of parameters of inflammation in blood (e.g., IL-6 in pg/ml)
Antioxidant system
Measurement of parameters of antioxidant system in blood (e.g., TEAC in mmol Trolox equivalents/L)
Fatty acid profile
Analysis of fatty acid profile in serum (e.g., alpha-linolenic acid in µmol/L)
Amino acid profile
Analysis of amino acid profile in blood (e.g., L-arginine in nmol/ml)

Full Information

First Posted
November 23, 2021
Last Updated
March 8, 2023
Sponsor
University of Bonn
Collaborators
Union for the Promotion of Oil and Protein Plants (UFOP, Germany)
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1. Study Identification

Unique Protocol Identification Number
NCT05208346
Brief Title
Effects of Canola Oil and Coconut Oil on Postprandial Metabolism in Older Adults With Increased Cardiometabolic Risk
Official Title
Acute Effects of Canola Oil Compared With Coconut Oil on Postprandial Metabolism in Women and Men With Increased Risk for Cardiometabolic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
October 18, 2022 (Actual)
Study Completion Date
October 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bonn
Collaborators
Union for the Promotion of Oil and Protein Plants (UFOP, Germany)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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, amino acid profile (e.g., L-arginine), fatty acid profile, neuropsychologic parameters (e.g., appetite) and satiety-associated hormones (e.g., PYY) are assessed. Each intervention arm will be separated by a washout period of 14 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Metabolic Syndrome
Keywords
Postprandial metabolic events

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canola oil high-fat
Arm Type
Experimental
Arm Description
Participants randomized to receive a mixed meal with 50 g canola oil
Arm Title
Coconut oil high-fat
Arm Type
Experimental
Arm Description
Participants randomized to receive a mixed meal with 50 g coconut oil
Arm Title
Canola oil low-fat
Arm Type
Experimental
Arm Description
Participants randomized to receive a mixed meal with 25 g canola oil
Arm Title
Coconut oil low-fat
Arm Type
Experimental
Arm Description
Participants randomized to receive a mixed meal with 25 g coconut oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixed meals
Intervention Description
Mixed meals enriched with either 25 or 50 g of canola or coconut oil
Primary Outcome Measure Information:
Title
Parameters of lipid metabolism in blood I
Description
Measurement of triglycerides (mg/dl)
Time Frame
Postprandial period of 6 hours
Title
Parameters of lipid metabolism in blood II
Description
Measurement of total cholesterol (mg/dl)
Time Frame
Postprandial period of 6 hours
Title
Parameters of lipid metabolism in blood III
Description
Measurement of LDL cholesterol (mg/dl)
Time Frame
Postprandial period of 6 hours
Title
Parameters of lipid metabolism in blood IV
Description
Measurement of HDL cholesterol (mg/dl)
Time Frame
Postprandial period of 6 hours
Title
Parameters of lipid metabolism in blood V
Description
Measurement of ApoB48 (g/L)
Time Frame
Postprandial period of 6 hours
Title
Parameters of lipid metabolism in blood VI
Description
Measurement of free fatty acids (mmol/L)
Time Frame
Postprandial period of 6 hours
Title
Parameters of glucose metabolism in blood I
Description
Measurement of glucose (mg/dl)
Time Frame
Postprandial period of 6 hours
Title
Parameters of glucose metabolism in blood II
Description
Measurement of insulin (nmol/L)
Time Frame
Postprandial period of 6 hours
Secondary Outcome Measure Information:
Title
Assessment of hunger
Description
Assessment of hunger via visual analogue scale (0 = not hungry at all, 10 = very hungry)
Time Frame
Postprandial period of 6 hours
Title
Assessment of attention
Description
Assessment of attention via validated neuropsychological questionnaires (paper-pencil)
Time Frame
Postprandial period of 6 hours
Title
Postprandial endothelial function
Description
Performance of pulse wave analysis with the Vicorder device (measurement of pulse wave velocity in m/s)
Time Frame
Postprandial period of 6 hours
Title
Parameters of endothelial function in blood
Description
Measurement of blood parameters of endothelial function (e.g., ADMA in µmol/L)
Time Frame
Postprandial period of 6 hours
Title
Postprandial inflammation
Description
Measurement of parameters of inflammation in blood (e.g., IL-6 in pg/ml)
Time Frame
Postprandial period of 6 hours
Title
Antioxidant system
Description
Measurement of parameters of antioxidant system in blood (e.g., TEAC in mmol Trolox equivalents/L)
Time Frame
Postprandial period of 6 hours
Title
Fatty acid profile
Description
Analysis of fatty acid profile in serum (e.g., alpha-linolenic acid in µmol/L)
Time Frame
Postprandial period of 6 hours
Title
Amino acid profile
Description
Analysis of amino acid profile in blood (e.g., L-arginine in nmol/ml)
Time Frame
Postprandial period of 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Egert, Prof. Dr.
Organizational Affiliation
University of Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bonn
City
Bonn
ZIP/Postal Code
53115
Country
Germany

12. IPD Sharing Statement

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Effects of Canola Oil and Coconut Oil on Postprandial Metabolism in Older Adults With Increased Cardiometabolic Risk

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