Clinical trial NCT05208346: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Metabolic Syndrome
Keywords: Postprandial metabolic events
Lead sponsor: University of Bonn
Sponsor class: OTHER
Collaborators: name: Union for the Promotion of Oil and Protein Plants (UFOP, Germany)
First posted: 2022-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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, fatty acid profile, neuropsychologic parameters (e.g., attention), subjective feeling of hunger and satiety, and satiety-associated hormones (e.g., ghrelin) are assessed. Each intervention arm will be separated by a washout period of about 14 days.

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

Primary outcomes:
measure: Parameters of lipid metabolism in blood I
timeFrame: Postprandial period of 6 hours
measure: Parameters of lipid metabolism in blood II
timeFrame: Postprandial period of 6 hours
measure: Parameters of lipid metabolism in blood III
timeFrame: Postprandial period of 6 hours
measure: Parameters of lipid metabolism in blood IV
timeFrame: Postprandial period of 6 hours
measure: Parameters of lipid metabolism in blood VI
timeFrame: Postprandial period of 6 hours
measure: Parameters of glucose metabolism in blood I
timeFrame: Postprandial period of 6 hours
measure: Parameters of glucose metabolism in blood II
timeFrame: Postprandial period of 6 hours
Secondary outcomes:
measure: Assessment of hunger and satiety
timeFrame: Postprandial period of 6 hours
measure: Assessment of gut hormones
timeFrame: Postprandial period of 6 hours
measure: Assessment of attention and memory
timeFrame: Postprandial period of 6 hours
measure: Postprandial endothelial function
timeFrame: Postprandial period of 6 hours
measure: Postprandial inflammation
timeFrame: Postprandial period of 6 hours
measure: Antioxidant system
timeFrame: Postprandial period of 6 hours
measure: Fatty acid profile
timeFrame: Postprandial period of 6 hours
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn
Study officials:
affiliation: University of Bonn
name: Sarah Egert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: