The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men (CocoHeart)
Primary Purpose
Cardiovascular Risk Factor
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Coconut oil
Butter
Vegetable oil
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Risk Factor focused on measuring Coconut oil, Postprandial lipaemia, Platelet function, Gastric emptying, Appetite
Eligibility Criteria
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
Sites / Locations
- Department of Food and Nutritional Sciences, University of Reading
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Meal rich in coconut oil
Meal rich in butter
Meal rich in vegetable oil
Arm Description
Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in coconut oil
Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in butter
Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in vegetable oil
Outcomes
Primary Outcome Measures
Change from baseline in postprandial triacylglycerol
Triacylglycerol
Secondary Outcome Measures
Fasting blood lipids
Total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol
Change from baseline in postprandial non-esterified fatty acids
Non-esterified fatty acids
Change from baseline in postprandial insulin
Insulin
Change from baseline in postprandial vascular stiffness
Measured via pulse wave assessment using the Mobil-O-graph device
Change from baseline in postprandial blood pressure
Systolic and diastolic blood pressure
Change from baseline in postprandial thrombin generation
Thrombin generation
Change from baseline in postprandial gastric emptying
Assessed using gas chromatography-mass spectrometry
Appetite rating
Assessed using 100 mm visual analogue questionnaire
Change from baseline in postprandial gut hormones
Ghrelin, peptide YY, gastric inhibitory polypeptide, glucagon-like peptide-1
Change from baseline in postprandial endothelial activation
E-selectin, P-selectin, vascular cell adhesion molecule 1, intercellular adhesion molecule-1
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
Weight
Body mass index will be calculated (kg/ height in m^2)
Body composition
Fat mass, fat free mass, trunk fat, trunk fat mass, trunk fat free mass
Habitual diet assessment
4-day food diary
Full Information
NCT ID
NCT05264233
First Posted
December 16, 2021
Last Updated
February 21, 2022
Sponsor
University of Reading
1. Study Identification
Unique Protocol Identification Number
NCT05264233
Brief Title
The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men
Acronym
CocoHeart
Official Title
The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor
Keywords
Coconut oil, Postprandial lipaemia, Platelet function, Gastric emptying, Appetite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meal rich in coconut oil
Arm Type
Active Comparator
Arm Description
Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in coconut oil
Arm Title
Meal rich in butter
Arm Type
Active Comparator
Arm Description
Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in butter
Arm Title
Meal rich in vegetable oil
Arm Type
Active Comparator
Arm Description
Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in vegetable oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Coconut oil
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Butter
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Vegetable oil
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in postprandial triacylglycerol
Description
Triacylglycerol
Time Frame
Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
Secondary Outcome Measure Information:
Title
Fasting blood lipids
Description
Total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol
Time Frame
Acute study: taken at 0 (baseline)
Title
Change from baseline in postprandial non-esterified fatty acids
Description
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
Title
Change from baseline in postprandial insulin
Description
Insulin
Time Frame
Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
Title
Change from baseline in postprandial vascular stiffness
Description
Measured via pulse wave assessment using the Mobil-O-graph device
Time Frame
Acute study: taken at 0 (baseline), 150, 315, 465 minutes
Title
Change from baseline in postprandial blood pressure
Description
Systolic and diastolic blood pressure
Time Frame
Acute study: taken at 0 (baseline), 180, 300, 480 minutes
Title
Change from baseline in postprandial thrombin generation
Description
Thrombin generation
Time Frame
Acute study: taken at 0 (baseline), 180, 330, 480 minutes
Title
Change from baseline in postprandial gastric emptying
Description
Assessed using gas chromatography-mass spectrometry
Time Frame
Acute study: taken at 15 minutes intervals between 0 min (baseline) and 480 minutes
Title
Appetite rating
Description
Assessed using 100 mm visual analogue questionnaire
Time Frame
Acute study: taken at 30 minutes intervals after the test meals up to 8 hours
Title
Change from baseline in postprandial gut hormones
Description
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
Title
Change from baseline in postprandial endothelial activation
Description
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
Title
Change from baseline in postprandial cytokine
Description
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
Title
Weight
Description
Body mass index will be calculated (kg/ height in m^2)
Time Frame
Acute study: taken at 0 (baseline)
Title
Body composition
Description
Fat mass, fat free mass, trunk fat, trunk fat mass, trunk fat free mass
Time Frame
Acute study: taken at 0 (baseline)
Title
Habitual diet assessment
Description
4-day food diary
Time Frame
Prior to the start of the study
Other Pre-specified Outcome Measures:
Title
Genotyping for apolipoprotein E
Description
Single nucleotide polymorphisms related to the metabolism of dietary fats
Time Frame
Acute study: taken at 0 (baseline)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie A Lovegrove, BSc PhD
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Food and Nutritional Sciences, University of Reading
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG6 6AP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men
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