The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men

Study Overview
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Brief Summary
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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.

Official Title
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The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Dietary Supplement: Coconut oil
* Dietary Supplement: Butter
* Dietary Supplement: Vegetable oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meal rich in coconut oil<br>Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in coconut oil | Dietary Supplement: Coconut oil<br>* 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<br>|
| Active Comparator: Meal rich in butter<br>Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in butter | Dietary Supplement: Butter<br>* 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<br>|
| Active Comparator: Meal rich in vegetable oil<br>Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in vegetable oil | Dietary Supplement: Vegetable oil<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in postprandial triacylglycerol | Triacylglycerol | Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood lipids | Total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol | Acute study: taken at 0 (baseline) | 
| Change from baseline in postprandial non-esterified fatty acids | Non-esterified fatty acids | 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 | 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 | Acute study: taken at 0 (baseline), 150, 315, 465 minutes | 
| Change from baseline in postprandial blood pressure | Systolic and diastolic blood pressure | Acute study: taken at 0 (baseline), 180, 300, 480 minutes | 
| Change from baseline in postprandial thrombin generation | Thrombin generation | Acute study: taken at 0 (baseline), 180, 330, 480 minutes | 
| Change from baseline in postprandial gastric emptying | Assessed using gas chromatography-mass spectrometry | Acute study: taken at 15 minutes intervals between 0 min (baseline) and 480 minutes | 
| Appetite rating | Assessed using 100 mm visual analogue questionnaire | 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 | 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 | 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 | Acute study: taken at 0 (baseline),180, 300 and 420 minutes | 
| Weight | Body mass index will be calculated (kg/ height in m^2) | Acute study: taken at 0 (baseline) | 
| Body composition | Fat mass, fat free mass, trunk fat, trunk fat mass, trunk fat free mass | Acute study: taken at 0 (baseline) | 
| Habitual diet assessment | 4-day food diary | Prior to the start of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coconut oil, Postprandial lipaemia, Platelet function, Gastric emptying, Appetite