An interventional study of Coconut oil and Butter in Cardiovascular Risk Factor, sponsored by University of Reading. Completed at 1 site in United Kingdom. Open to male participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by University of Reading · Not applicable, Interventional, and Treatment
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.
University of Reading is the lead sponsor of 150 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in coconut oil
Dietary Supplement: Coconut oil
Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in butter
Dietary Supplement: Butter
Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in vegetable oil
Dietary Supplement: Vegetable oil
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
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
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
Change from baseline in postprandial triacylglycerol
Triacylglycerol
Time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
Fasting blood lipids
Total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol
Time frame: Acute study: taken at 0 (baseline)
Change from baseline in postprandial non-esterified fatty acids
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
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
Measured via pulse wave assessment using the Mobil-O-graph device
Time frame: Acute study: taken at 0 (baseline), 150, 315, 465 minutes
Change from baseline in postprandial blood pressure
Systolic and diastolic blood pressure
Time frame: Acute study: taken at 0 (baseline), 180, 300, 480 minutes
Change from baseline in postprandial thrombin generation
Thrombin generation
Time frame: Acute study: taken at 0 (baseline), 180, 330, 480 minutes
Change from baseline in postprandial gastric emptying
Assessed using gas chromatography-mass spectrometry
Time frame: Acute study: taken at 15 minutes intervals between 0 min (baseline) and 480 minutes
Appetite rating
Assessed using 100 mm visual analogue questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
Weight
Body mass index will be calculated (kg/ height in m\^2)
Time frame: Acute study: taken at 0 (baseline)
Body composition
Fat mass, fat free mass, trunk fat, trunk fat mass, trunk fat free mass
Time frame: Acute study: taken at 0 (baseline)
Habitual diet assessment
4-day food diary
Time frame: Prior to the start of the study
Genotyping for apolipoprotein E
Single nucleotide polymorphisms related to the metabolism of dietary fats
Time frame: Acute study: taken at 0 (baseline)
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Coconut Oil · Plant Oils