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

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 Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Dietary supplement: Coconut oil; Dietary supplement: Butter; Dietary supplement: Vegetable oil

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6AP
      • Department of Food and Nutritional Sciences, University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Meal rich in coconut oil; Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in coconut oil	Dietary supplement: Coconut 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
ACTIVE_COMPARATOR: Meal rich in butter; Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in butter	Dietary supplement: Butter; 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
ACTIVE_COMPARATOR: Meal rich in vegetable oil; 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 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genotyping for apolipoprotein E	Single nucleotide polymorphisms related to the metabolism of dietary fats	Acute study: taken at 0 (baseline)

Collaborators and Investigators

• Sponsor: University of Reading

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2020
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (ACTUAL): March 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Gastric emptying; Platelet function; Appetite; Coconut oil; Postprandial lipaemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: 19/30

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No