Cardiovascular Risk FactorCocoHeartNCT05264233
The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men
A study testing Coconut oil, Butter and Vegetable oil in people with Cardiovascular Risk Factor, run by University of Reading at 1 site in United Kingdom.
Trial summary
Current dietary recommendations suggest that lowering intake of saturated fats or replacing it with unsaturated fats will decrease the risk of developing cardiovascular disease. Coconut oil has gained popularity in recent years but it contains 90% saturated fat, which has higher percentage of saturated fat than… Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Coconut oil, Butter and Vegetable oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jan 2020to 30 Sep 2021
- 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 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men
- Aged between 30 to 70 years
- Serum triacylglycerol < 2.3 mmol/l
- Body mass index between 19-32 kg/m2
- Total cholesterol < 7.5 mmol/l
Who cannot join
- Females
- Smokers
- Medical history of myocardial infarction or stroke in the past 12 months
- Diabetes (defined as fasting glucose > 7.0 mmol/l) or other endocrine disorders
- Kidney, liver, pancreas or gastrointestinal disorder
- Hypertension (blood pressure > 140/90 mmHg), cancer, medication for hyperlipidaemia (e.g. statins), hypertension or, inflammation
Show all 12Show fewer
- Anaemia (<130 g/L haemoglobin)
- Taking any dietary supplements known to influence lipids/gut microbiota (e.g. plant stanols, fish oil, phytochemicals, natural laxatives, probiotics and prebiotics)
- Drinking in excess of 14 units of alcohol per week
- Planning on a weight-reducing regime
- Parallel participation in another dietary intervention study
- Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention and metabolic study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, RG6 6AP
About this study
Current dietary recommendations suggest that lowering intake of saturated fats or replacing it with unsaturated fats will decrease the risk of developing cardiovascular disease. Coconut oil has gained popularity in recent years but it contains 90% saturated fat, which has higher percentage of saturated fat than butter. To date, only limited studies have determined the acute effects of meals containing coconut oil on blood lipids, but findings are inconsistent. Therefore, further studies are needed to address this knowledge gap and compare the postprandial effects of test meals rich in coconut oil with other sources of saturated fatty acids such as butter and unsaturated fatty acids (vegetable oils). A cross-over, double-blind, randomised acute postprandial study will be conducted in 15 healthy men. Participants will be assigned to consume the test meals rich in saturated or unsaturated fatty acids in random order on 3 separate occasions, with 3-4 weeks between each study visit. Participants will be provided with breakfast (toast with jam and milkshake, 50g fat) and lunch (toast with jam and milkshake, 30g fat). The anthropometric, blood pressure, arterial stiffness, and breath samples will be taken for each study visit. Blood samples will be collected for the measurement of fasting lipids, glucose, insulin, inflammatory markers, whole blood culture as well as blood clotting. Breath samples are collected for the measurement of gastric emptying as well as assessment of satiety using questionnaires (100 mm visual analogue scale) completed throughout the day. The findings from this study will contribute to the evidence base on how consuming meals rich in coconut oil influence the level of blood lipids as well as other biomarkers for cardiovascular disease.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Coconut oil, Butter, Vegetable oil
- Keywords
- Coconut oil, Postprandial lipaemia, Platelet function, Gastric emptying, Appetite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut oilDietary supplement
50 g of coconut oil will be added to the test meal for breakfast and 30 g of coconut oil will be added to the test meal for lunch
ButterDietary supplement
50 g of butter will be added to the test meal for breakfast and 30 g of butter will be added to the test meal for lunch
Vegetable oilDietary supplement
50 g of vegetable oil will be added to the test meal for breakfast and 30 g of vegetable oil will be added to the test meal for lunch
| Study group | Role | What they receive |
|---|---|---|
| Meal rich in coconut oil | Active comparator | Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in coconut oil Receives: Dietary Supplement: Coconut oil |
| Meal rich in butter | Active comparator | Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in butter Receives: Dietary Supplement: Butter |
| Meal rich in vegetable oil | Active comparator | Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in vegetable oil Receives: Dietary Supplement: Vegetable oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in postprandial triacylglycerol
Triacylglycerol
Measured: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
Secondary outcomes (14)
Fasting blood lipids
Total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol
Measured: Acute study: taken at 0 (baseline)
Change from baseline in postprandial non-esterified fatty acids
Non-esterified fatty acids
Measured: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
Change from baseline in postprandial insulin
Insulin
Measured: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
Change from baseline in postprandial vascular stiffness
Measured via pulse wave assessment using the Mobil-O-graph device
Measured: Acute study: taken at 0 (baseline), 150, 315, 465 minutes
Change from baseline in postprandial blood pressure
Systolic and diastolic blood pressure
Measured: Acute study: taken at 0 (baseline), 180, 300, 480 minutes
Change from baseline in postprandial thrombin generation
Thrombin generation
Measured: Acute study: taken at 0 (baseline), 180, 330, 480 minutes
Change from baseline in postprandial gastric emptying
Assessed using gas chromatography-mass spectrometry
Measured: Acute study: taken at 15 minutes intervals between 0 min (baseline) and 480 minutes
Appetite rating
Assessed using 100 mm visual analogue questionnaire
Measured: Acute study: taken at 30 minutes intervals after the test meals up to 8 hours
Change from baseline in postprandial gut hormones
Ghrelin, peptide YY, gastric inhibitory polypeptide, glucagon-like peptide-1
Measured: Acute study: taken at 0 (baseline), 30, 60, 120, 240, 330, 360, 390 & 480 minutes
Change from baseline in postprandial endothelial activation
E-selectin, P-selectin, vascular cell adhesion molecule 1, intercellular adhesion molecule-1
Measured: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
Change from baseline in postprandial cytokine
Interleukin 6, interleukin 1 beta, interleukin 10, tumour necrosis factor alpha, C-C motif chemokine ligand 5, C-X-C motif chemokine ligand 5
Measured: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
Weight
Body mass index will be calculated (kg/ height in m^2)
Measured: Acute study: taken at 0 (baseline)
Body composition
Fat mass, fat free mass, trunk fat, trunk fat mass, trunk fat free mass
Measured: Acute study: taken at 0 (baseline)
Habitual diet assessment
4-day food diary
Measured: Prior to the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start13 Jan 2020
- Primary completion30 Jun 2021
- Study completion30 Sep 2021
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 Risk FactorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie A Lovegrove, BSc PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264233
- Sponsor's protocol ID
- 19/30
- Acronym
- CocoHeart
- Status last verified
- Feb 2022
- First submitted
- 16 Dec 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong G, Clegg ME, Ross D, Lovegrove JA, Jackson KG. Sequential Meals Containing Animal and Plant-Based Saturated Fats Have Differential Effects on Postprandial Gut Hormones but No Impact on Satiety Compared with Unsaturated Fats in Generally Healthy Males: Findings from the Randomized Controlled Crossover CocoHeart Study. J Nutr. 2025 Jul 1;155(9):3020-9. doi: 10.1016/j.tjnut.2025.06.027. Online ahead of print.
PubMed 40609691
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men
- ClinicalTrials.gov ID
- NCT05264233
- Acronym / sponsor ID
- CocoHeart / 19/30
- Conditions
- Cardiovascular Risk Factor
- Keywords
- Coconut oil, Postprandial lipaemia, Platelet function, Gastric emptying, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 3 Mar 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.
Current dietary recommendations suggest that lowering intake of saturated fats or replacing it with unsaturated fats will decrease the risk of developing cardiovascular disease. Coconut oil has gained popularity in recent years but it contains 90% saturated fat, which has higher percentage of saturated fat than butter. To date, only limited studies have determined the acute effects of meals containing coconut oil on blood lipids, but findings are inconsistent. Therefore, further studies are needed to address this knowledge gap and compare the postprandial effects of test meals rich in coconut oil with other sources of saturated fatty acids such as butter and unsaturated fatty acids (vegetable oils). A cross-over, double-blind, randomised acute postprandial study will be conducted in 15 healthy men. Participants will be assigned to consume the test meals rich in saturated or unsaturated fatty acids in random order on 3 separate occasions, with 3-4 weeks between each study visit. Participants will be provided with breakfast (toast with jam and milkshake, 50g fat) and lunch (toast with jam and milkshake, 30g fat). The anthropometric, blood pressure, arterial stiffness, and breath samples will be taken for each study visit. Blood samples will be collected for the measurement of fasting lipids, glucose, insulin, inflammatory markers, whole blood culture as well as blood clotting. Breath samples are collected for the measurement of gastric emptying as well as assessment of satiety using questionnaires (100 mm visual analogue scale) completed throughout the day. The findings from this study will contribute to the evidence base on how consuming meals rich in coconut oil influence the level of blood lipids as well as other biomarkers for cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meal rich in coconut oil | Active comparator | Dietary Supplement: Coconut oilParticipants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in coconut oil |
| Meal rich in butter | Active comparator | Dietary Supplement: ButterParticipants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in butter |
| Meal rich in vegetable oil | Active comparator | Dietary Supplement: Vegetable oilParticipants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in vegetable oil |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy men
- Aged between 30 to 70 years
- Serum triacylglycerol < 2.3 mmol/l
- Body mass index between 19-32 kg/m2
- Total cholesterol < 7.5 mmol/l
Key exclusion criteria (12 listed)
- Females
- Smokers
- Medical history of myocardial infarction or stroke in the past 12 months
- Diabetes (defined as fasting glucose > 7.0 mmol/l) or other endocrine disorders
- Kidney, liver, pancreas or gastrointestinal disorder
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 |
|---|---|---|
| Coconut oil50 g of coconut oil will be added to the test meal for breakfast and 30 g of coconut oil will be added to the test meal for lunch | Dietary supplement | Meal rich in coconut oil |
| Butter50 g of butter will be added to the test meal for breakfast and 30 g of butter will be added to the test meal for lunch | Dietary supplement | Meal rich in butter |
| Vegetable oil50 g of vegetable oil will be added to the test meal for breakfast and 30 g of vegetable oil will be added to the test meal for lunch | Dietary supplement | Meal rich in vegetable oil |
Primary outcome
Change from baseline in postprandial triacylglycerol
Time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
Triacylglycerol
14 secondary outcomes
Fasting blood lipids
Time frame: Acute study: taken at 0 (baseline)
Change from baseline in postprandial non-esterified fatty acids
Time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
Change from baseline in postprandial insulin
Time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
Change from baseline in postprandial vascular stiffness
Time frame: Acute study: taken at 0 (baseline), 150, 315, 465 minutes
Change from baseline in postprandial blood pressure
Time frame: Acute study: taken at 0 (baseline), 180, 300, 480 minutes
Change from baseline in postprandial thrombin generation
Time frame: Acute study: taken at 0 (baseline), 180, 330, 480 minutes
Change from baseline in postprandial gastric emptying
Time frame: Acute study: taken at 15 minutes intervals between 0 min (baseline) and 480 minutes
Appetite rating
Time frame: Acute study: taken at 30 minutes intervals after the test meals up to 8 hours
Change from baseline in postprandial gut hormones
Time frame: Acute study: taken at 0 (baseline), 30, 60, 120, 240, 330, 360, 390 & 480 minutes
Change from baseline in postprandial endothelial activation
Time frame: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
Change from baseline in postprandial cytokine
Time frame: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
Weight
Time frame: Acute study: taken at 0 (baseline)
Body composition
Time frame: Acute study: taken at 0 (baseline)
Habitual diet assessment
Time frame: Prior to the start of the study
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 3 Mar 2022.
- Derived from this study: PubMed 40609691Wong G, Clegg ME, Ross D, Lovegrove JA, Jackson KG. Sequential Meals Containing Animal and Plant-Based Saturated Fats Have Differential Effects on Postprandial Gut Hormones but No Impact on Satiety Compared with Unsaturated Fats in Generally Healthy Males: Findings from the Randomized Controlled Crossover CocoHeart Study. J Nutr. 2025 Jul 1;155(9):3020-9. doi: 10.1016/j.tjnut.2025.06.027. Online ahead of print.
Related trials for Cardiovascular Risk Factor
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
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.
Julie A Lovegrove, BSc PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coconut oil, Butter and Vegetable oil in people with Cardiovascular Risk Factor, run by University of Reading at 1 site in United Kingdom.
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 5 inclusion and 12 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 3 Mar 2022. 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 United Kingdom. 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?
Change from baseline in postprandial triacylglycerol (time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes). 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 NCT05264233, 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 3 Mar 2022.