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

February 21, 2022 updated by: Julie Lovegrove, University of Reading
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6AP
        • Department of Food and Nutritional Sciences, University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Meal rich in coconut oil
Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in coconut oil
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
ACTIVE_COMPARATOR: Meal rich in butter
Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in butter
Dietary supplement: 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
ACTIVE_COMPARATOR: Meal rich in vegetable oil
Participants will be asked to consume a breakfast (0 minute) and lunch (330 minute) rich in vegetable oil
Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fasting blood lipids
Time Frame: Acute study: taken at 0 (baseline)
Total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol
Acute study: taken at 0 (baseline)
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
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
Time Frame: Acute study: taken at 0 (baseline), 30, 60, 90, 120, 180, 240, 300, 330, 360, 390, 420, 480 minutes
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
Time Frame: Acute study: taken at 0 (baseline), 150, 315, 465 minutes
Measured via pulse wave assessment using the Mobil-O-graph device
Acute study: taken at 0 (baseline), 150, 315, 465 minutes
Change from baseline in postprandial blood pressure
Time Frame: Acute study: taken at 0 (baseline), 180, 300, 480 minutes
Systolic and diastolic blood pressure
Acute study: taken at 0 (baseline), 180, 300, 480 minutes
Change from baseline in postprandial thrombin generation
Time Frame: Acute study: taken at 0 (baseline), 180, 330, 480 minutes
Thrombin generation
Acute study: taken at 0 (baseline), 180, 330, 480 minutes
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
Acute study: taken at 15 minutes intervals between 0 min (baseline) and 480 minutes
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
Acute study: taken at 30 minutes intervals after the test meals up to 8 hours
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
Acute study: taken at 0 (baseline), 30, 60, 120, 240, 330, 360, 390 & 480 minutes
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
Acute study: taken at 0 (baseline),180, 300 and 420 minutes
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
Acute study: taken at 0 (baseline),180, 300 and 420 minutes
Weight
Time Frame: Acute study: taken at 0 (baseline)
Body mass index will be calculated (kg/ height in m^2)
Acute study: taken at 0 (baseline)
Body composition
Time Frame: Acute study: taken at 0 (baseline)
Fat mass, fat free mass, trunk fat, trunk fat mass, trunk fat free mass
Acute study: taken at 0 (baseline)
Habitual diet assessment
Time Frame: Prior to the start of the study
4-day food diary
Prior to the start of the study

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Genotyping for apolipoprotein E
Time Frame: Acute study: taken at 0 (baseline)
Single nucleotide polymorphisms related to the metabolism of dietary fats
Acute study: taken at 0 (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Reading

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19/30

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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