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

Cardiovascular Risk Factor Clinical Trial

— CocoHeart  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05264233
• Other study ID #: 19/30
• Status: Completed
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2022
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Hyperlipidemias

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences, University of Reading	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Genotyping for apolipoprotein E	Single nucleotide polymorphisms related to the metabolism of dietary fats	Acute study: taken at 0 (baseline)
Primary	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	Fasting blood lipids	Total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol	Acute study: taken at 0 (baseline)
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline in postprandial blood pressure	Systolic and diastolic blood pressure	Acute study: taken at 0 (baseline), 180, 300, 480 minutes
Secondary	Change from baseline in postprandial thrombin generation	Thrombin generation	Acute study: taken at 0 (baseline), 180, 330, 480 minutes
Secondary	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
Secondary	Appetite rating	Assessed using 100 mm visual analogue questionnaire	Acute study: taken at 30 minutes intervals after the test meals up to 8 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Weight	Body mass index will be calculated (kg/ height in m^2)	Acute study: taken at 0 (baseline)
Secondary	Body composition	Fat mass, fat free mass, trunk fat, trunk fat mass, trunk fat free mass	Acute study: taken at 0 (baseline)
Secondary	Habitual diet assessment	4-day food diary	Prior to the start of the study