Clinical trial NCT05264233: The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men
Official title: The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: Coconut oil
Postprandial lipaemia
Platelet function
Gastric emptying
Appetite
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 13
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in postprandial triacylglycerol
timeFrame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
Secondary outcomes:
measure: Fasting blood lipids
timeFrame: Acute study: taken at 0 (baseline)
measure: Change from baseline in postprandial non-esterified fatty acids
timeFrame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
measure: Change from baseline in postprandial insulin
timeFrame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
measure: Change from baseline in postprandial vascular stiffness
timeFrame: Acute study: taken at 0 (baseline), 150, 315, 465 minutes
measure: Change from baseline in postprandial blood pressure
timeFrame: Acute study: taken at 0 (baseline), 180, 300, 480 minutes
measure: Change from baseline in postprandial thrombin generation
timeFrame: Acute study: taken at 0 (baseline), 180, 330, 480 minutes
measure: Change from baseline in postprandial gastric emptying
timeFrame: Acute study: taken at 15 minutes intervals between 0 min (baseline) and 480 minutes
measure: Appetite rating
timeFrame: Acute study: taken at 30 minutes intervals after the test meals up to 8 hours
measure: Change from baseline in postprandial gut hormones
timeFrame: Acute study: taken at 0 (baseline), 30, 60, 120, 240, 330, 360, 390 & 480 minutes
measure: Change from baseline in postprandial endothelial activation
timeFrame: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
measure: Change from baseline in postprandial cytokine
timeFrame: Acute study: taken at 0 (baseline),180, 300 and 420 minutes
measure: Weight
timeFrame: Acute study: taken at 0 (baseline)
measure: Body composition
timeFrame: Acute study: taken at 0 (baseline)
measure: Habitual diet assessment
timeFrame: Prior to the start of the study
Other outcomes:
measure: Genotyping for apolipoprotein E
timeFrame: Acute study: taken at 0 (baseline)
Locations:
city: Reading
country: United Kingdom
facility: Department of Food and Nutritional Sciences, University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Julie A Lovegrove, BSc PhD
role: PRINCIPAL_INVESTIGATOR
References: