Cardiovascular DiseasesNCT05208346
Effects of Canola Oil and Coconut Oil on Postprandial Metabolism in Older Adults With Increased Cardiometabolic Risk
A study testing Mixed meals in people with Cardiovascular Diseases and Metabolic Syndrome, run by University of Bonn at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Metabolic Syndrome
- What is being tested?
- Mixed meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 9 Mar 2022to 18 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome
- Being tested
- Mixed meals
- Keywords
- Postprandial metabolic events
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed mealsDietary supplement
Mixed meals enriched with either 25 or 50 g of canola or coconut oil
| Study group | Role | What they receive |
|---|---|---|
| Canola oil high-fat | Experimental | Participants randomized to receive a mixed meal with 50 g canola oil Receives: Dietary Supplement: Mixed meals |
| Coconut oil high-fat | Experimental | Participants randomized to receive a mixed meal with 50 g coconut oil Receives: Dietary Supplement: Mixed meals |
| Canola oil low-fat | Experimental | Participants randomized to receive a mixed meal with 25 g canola oil Receives: Dietary Supplement: Mixed meals |
| Coconut oil low-fat | Experimental | Participants randomized to receive a mixed meal with 25 g coconut oil Receives: Dietary Supplement: Mixed meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters of lipid metabolism in blood I
Measurement of triglycerides (mg/dl)
Measured: Postprandial period of 6 hours
Parameters of lipid metabolism in blood II
Measurement of total cholesterol (mg/dl)
Measured: Postprandial period of 6 hours
Parameters of lipid metabolism in blood III
Measurement of LDL cholesterol (mg/dl)
Measured: Postprandial period of 6 hours
Parameters of lipid metabolism in blood IV
Measurement of HDL cholesterol (mg/dl)
Measured: Postprandial period of 6 hours
Parameters of lipid metabolism in blood VI
Measurement of free fatty acids (mmol/L)
Measured: Postprandial period of 6 hours
Parameters of glucose metabolism in blood I
Measurement of glucose (mg/dl)
Measured: Postprandial period of 6 hours
Parameters of glucose metabolism in blood II
Measurement of insulin (nmol/L)
Measured: Postprandial period of 6 hours
Secondary outcomes (7)
Assessment of hunger and satiety
Assessment via visual analogue scales (e.g., 0 = not hungry at all, 10 = very hungry)
Measured: Postprandial period of 6 hours
Assessment of gut hormones
Measurement of gut hormones associated with hunger and satiety in blood (ghrelin in pg/ml; PYY in pg/ml)
Measured: Postprandial period of 6 hours
Assessment of attention and memory
Assessment via validated neuropsychological questionnaires (paper-pencil)
Measured: Postprandial period of 6 hours
Postprandial endothelial function
Assessment via the Vicorder device (e.g., measurement of pulse wave velocity in m/s)
Measured: Postprandial period of 6 hours
Postprandial inflammation
Measurement of parameters of inflammation in blood (e.g., IL-6 in pg/ml)
Measured: Postprandial period of 6 hours
Antioxidant system
Measurement of parameters of antioxidant system in blood (e.g., TEAC in mmol Trolox equivalents/L)
Measured: Postprandial period of 6 hours
Fatty acid profile
Analysis of fatty acid profile in serum (e.g., alpha-linolenic acid in µmol/L)
Measured: Postprandial period of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start9 Mar 2022
- Primary completion18 Oct 2022
- Study completion18 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Union for the Promotion of Oil and Protein Plants (UFOP, Germany)
- Responsible party
- Principal investigator, Prof. Dr. Sarah Egert, University of Bonn
- Investigators
- Sarah Egert, Prof. Dr., Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208346
- Sponsor's protocol ID
- 528/191
- Status last verified
- Apr 2025
- First submitted
- 23 Nov 2021
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Diekmann C, Schiemann TB, Kienes HF, Wiechmann C, Kopp C, Stoffel-Wagner B, Coenen M, Nemeth R, Wagner M, Egert S. Fat Amount Rather Than Fatty Acid Composition Influences Postprandial Hunger, Satiety and Attention in Men and Women with a Risk Phenotype for Cardiometabolic Diseases: A Randomized Crossover Trial. J Nutr. 2026 Jan;156(1):101232. doi: 10.1016/j.tjnut.2025.11.003. Epub 2025 Nov 11.
PubMed 41232773
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Canola Oil Compared With Coconut Oil on Postprandial Metabolism in Women and Men With Increased Risk for Cardiometabolic Diseases
- ClinicalTrials.gov ID
- NCT05208346
- Acronym / sponsor ID
- 528/191
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome
- Keywords
- Postprandial metabolic events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Collaborators
- Union for the Promotion of Oil and Protein Plants (UFOP, Germany)
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Canola oil high-fat | Experimental | Dietary Supplement: Mixed mealsParticipants randomized to receive a mixed meal with 50 g canola oil |
| Coconut oil high-fat | Experimental | Dietary Supplement: Mixed mealsParticipants randomized to receive a mixed meal with 50 g coconut oil |
| Canola oil low-fat | Experimental | Dietary Supplement: Mixed mealsParticipants randomized to receive a mixed meal with 25 g canola oil |
| Coconut oil low-fat | Experimental | Dietary Supplement: Mixed mealsParticipants randomized to receive a mixed meal with 25 g coconut oil |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed mealsMixed meals enriched with either 25 or 50 g of canola or coconut oil | Dietary supplement | Canola oil high-fat, Canola oil low-fat, Coconut oil high-fat, Coconut oil low-fat |
Primary outcome
Parameters of lipid metabolism in blood I
Time frame: Postprandial period of 6 hours
Measurement of triglycerides (mg/dl)
Parameters of lipid metabolism in blood II
Time frame: Postprandial period of 6 hours
Measurement of total cholesterol (mg/dl)
Parameters of lipid metabolism in blood III
Time frame: Postprandial period of 6 hours
Measurement of LDL cholesterol (mg/dl)
Parameters of lipid metabolism in blood IV
Time frame: Postprandial period of 6 hours
Measurement of HDL cholesterol (mg/dl)
Parameters of lipid metabolism in blood VI
Time frame: Postprandial period of 6 hours
Measurement of free fatty acids (mmol/L)
Parameters of glucose metabolism in blood I
Time frame: Postprandial period of 6 hours
Measurement of glucose (mg/dl)
Parameters of glucose metabolism in blood II
Time frame: Postprandial period of 6 hours
Measurement of insulin (nmol/L)
7 secondary outcomes
Assessment of hunger and satiety
Time frame: Postprandial period of 6 hours
Assessment of gut hormones
Time frame: Postprandial period of 6 hours
Assessment of attention and memory
Time frame: Postprandial period of 6 hours
Postprandial endothelial function
Time frame: Postprandial period of 6 hours
Postprandial inflammation
Time frame: Postprandial period of 6 hours
Antioxidant system
Time frame: Postprandial period of 6 hours
Fatty acid profile
Time frame: Postprandial period of 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Derived from this study: PubMed 41232773Diekmann C, Schiemann TB, Kienes HF, Wiechmann C, Kopp C, Stoffel-Wagner B, Coenen M, Nemeth R, Wagner M, Egert S. Fat Amount Rather Than Fatty Acid Composition Influences Postprandial Hunger, Satiety and Attention in Men and Women with a Risk Phenotype for Cardiometabolic Diseases: A Randomized Crossover Trial. J Nutr. 2026 Jan;156(1):101232. doi: 10.1016/j.tjnut.2025.11.003. Epub 2025 Nov 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Egert, Prof. Dr. principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed meals in people with Cardiovascular Diseases and Metabolic Syndrome, run by University of Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameters of lipid metabolism in blood I (time frame: Postprandial period of 6 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05208346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.