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Completed

NCT Number: NCT05264233

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

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.

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Key information

Conditions

Cardiovascular Risk Factor

Age range

30 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coconut oil

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

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 outcomes

  1. Change from baseline in postprandial triacylglycerol

    Time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes

    Triacylglycerol

Secondary outcomes

  1. Fasting blood lipids

    Time frame: Acute study: taken at 0 (baseline)

    Total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol

  2. Change from baseline in postprandial 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

    Non-esterified fatty acids

  3. Change from baseline in postprandial insulin

    Time frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes

    Insulin

  4. Change from baseline in postprandial vascular stiffness

    Time frame: Acute study: taken at 0 (baseline), 150, 315, 465 minutes

    Measured via pulse wave assessment using the Mobil-O-graph device

  5. Change from baseline in postprandial blood pressure

    Time frame: Acute study: taken at 0 (baseline), 180, 300, 480 minutes

    Systolic and diastolic blood pressure

  6. Change from baseline in postprandial thrombin generation

    Time frame: Acute study: taken at 0 (baseline), 180, 330, 480 minutes

    Thrombin generation

  7. Change from baseline in postprandial gastric emptying

    Time frame: Acute study: taken at 15 minutes intervals between 0 min (baseline) and 480 minutes

    Assessed using gas chromatography-mass spectrometry

  8. Appetite rating

    Time frame: Acute study: taken at 30 minutes intervals after the test meals up to 8 hours

    Assessed using 100 mm visual analogue questionnaire

  9. Change from baseline in postprandial gut hormones

    Time frame: Acute study: taken at 0 (baseline), 30, 60, 120, 240, 330, 360, 390 & 480 minutes

    Ghrelin, peptide YY, gastric inhibitory polypeptide, glucagon-like peptide-1

  10. Change from baseline in postprandial endothelial activation

    Time frame: Acute study: taken at 0 (baseline),180, 300 and 420 minutes

    E-selectin, P-selectin, vascular cell adhesion molecule 1, intercellular adhesion molecule-1

  11. Change from baseline in postprandial cytokine

    Time frame: Acute study: taken at 0 (baseline),180, 300 and 420 minutes

    Interleukin 6, interleukin 1 beta, interleukin 10, tumour necrosis factor alpha, C-C motif chemokine ligand 5, C-X-C motif chemokine ligand 5

  12. Weight

    Time frame: Acute study: taken at 0 (baseline)

    Body mass index will be calculated (kg/ height in m^2)

  13. Body composition

    Time frame: Acute study: taken at 0 (baseline)

    Fat mass, fat free mass, trunk fat, trunk fat mass, trunk fat free mass

  14. Habitual diet assessment

    Time frame: Prior to the start of the study

    4-day food diary

Other outcomes

  1. Genotyping for apolipoprotein E

    Time frame: Acute study: taken at 0 (baseline)

    Single nucleotide polymorphisms related to the metabolism of dietary fats

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Acronym: CocoHeart

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2022
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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