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

Cardiovascular Diseases Clinical Trial

Official title:

Acute Effects of Canola Oil Compared With Coconut Oil on Postprandial Metabolism in Women and Men With Increased Risk for Cardiometabolic Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05208346
• Other study ID #: 528/191
• Status: Completed
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: October 18, 2022

Study information

• Verified date: November 2023
• Source: University of Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 18, 2022
• Est. primary completion date: October 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Syndrome

Intervention

Dietary Supplement:
• Mixed meals
Mixed meals enriched with either 25 or 50 g of canola or coconut oil

Locations

Country	Name	City	State
Germany	University of Bonn	Bonn

Sponsors (2)

Lead Sponsor	Collaborator
University of Bonn	Union for the Promotion of Oil and Protein Plants (UFOP, Germany)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parameters of lipid metabolism in blood I	Measurement of triglycerides (mg/dl)	Postprandial period of 6 hours
Primary	Parameters of lipid metabolism in blood II	Measurement of total cholesterol (mg/dl)	Postprandial period of 6 hours
Primary	Parameters of lipid metabolism in blood III	Measurement of LDL cholesterol (mg/dl)	Postprandial period of 6 hours
Primary	Parameters of lipid metabolism in blood IV	Measurement of HDL cholesterol (mg/dl)	Postprandial period of 6 hours
Primary	Parameters of lipid metabolism in blood VI	Measurement of free fatty acids (mmol/L)	Postprandial period of 6 hours
Primary	Parameters of glucose metabolism in blood I	Measurement of glucose (mg/dl)	Postprandial period of 6 hours
Primary	Parameters of glucose metabolism in blood II	Measurement of insulin (nmol/L)	Postprandial period of 6 hours
Secondary	Assessment of hunger and satiety	Assessment via visual analogue scales (e.g., 0 = not hungry at all, 10 = very hungry)	Postprandial period of 6 hours
Secondary	Assessment of attention and memory	Assessment via validated neuropsychological questionnaires (paper-pencil)	Postprandial period of 6 hours
Secondary	Postprandial endothelial function	Assessment via the Vicorder device (e.g., measurement of pulse wave velocity in m/s)	Postprandial period of 6 hours
Secondary	Postprandial inflammation	Measurement of parameters of inflammation in blood (e.g., IL-6 in pg/ml)	Postprandial period of 6 hours
Secondary	Antioxidant system	Measurement of parameters of antioxidant system in blood (e.g., TEAC in mmol Trolox equivalents/L)	Postprandial period of 6 hours
Secondary	Fatty acid profile	Analysis of fatty acid profile in serum (e.g., alpha-linolenic acid in µmol/L)	Postprandial period of 6 hours