NCT05264233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

December 16, 2021

Last Update Submit

February 21, 2022

Conditions

Cardiovascular Risk Factor

Keywords

Coconut oilPostprandial lipaemiaPlatelet functionGastric emptyingAppetite

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Fasting blood lipids

    Acute study: taken at 0 (baseline)

  • Change from baseline in postprandial 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

    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

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

  • Change from baseline in postprandial blood pressure

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

  • +9 more secondary outcomes

Other Outcomes (1)

  • Genotyping for apolipoprotein E

    Acute study: taken at 0 (baseline)

Study Arms (3)

Meal rich in coconut oil

ACTIVE COMPARATOR

Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in coconut oil

Dietary Supplement: Coconut oil

Meal rich in butter

ACTIVE COMPARATOR

Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in butter

Dietary Supplement: Butter

Meal rich in vegetable oil

ACTIVE COMPARATOR

Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in vegetable oil

Dietary Supplement: Vegetable oil

Interventions

Coconut oilDIETARY_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

Meal rich in coconut oil
ButterDIETARY_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

Meal rich in butter
Vegetable oilDIETARY_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

Meal rich in vegetable oil

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related Publications (1)

  • Wong G, Clegg ME, Ross D, Lovegrove JA, Jackson KG. Sequential Meals Containing Animal and Plant-Based Saturated Fats Have Differential Effects on Postprandial Gut Hormones but No Impact on Satiety Compared with Unsaturated Fats in Generally Healthy Males: Findings from the Randomized Controlled Crossover CocoHeart Study. J Nutr. 2025 Jul 1:S0022-3166(25)00416-X. doi: 10.1016/j.tjnut.2025.06.027. Online ahead of print.

    PMID: 40609691DERIVED

MeSH Terms

Interventions

Coconut OilButterPlant Oils

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsOilsDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Julie A Lovegrove, BSc PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Hugh Sinclair Unit

Study Record Dates

First Submitted

December 16, 2021

First Posted

March 3, 2022

Study Start

January 13, 2020

Primary Completion

June 30, 2021

Study Completion

September 30, 2021

Last Updated

March 3, 2022

Record last verified: 2022-02

Locations

GB(1)