The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular Health; a Randomised Controlled Trial (INTER-CARDIO)

The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular

The purpose of this study is to investigate whether there are differences in postprandial cardiometabolic metabolic indices following interesterified fats used commercially versus application appropriate non- interesterifed alternative fat.

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Dietary supplement: Interesterified fat; Dietary supplement: Non- interesterified fat; Dietary supplement: Rapeseed oil; Dietary supplement: Butter

Detailed Description

Aim: The current study aims to investigate the acute effects of commercially available interesterified fat versus versus application appropriate non- interesterifed alternative fat on 8 h postprandial cardiometabolic outcomes.

Hypothesis: Interesterified fat will induce a different cardiomtabolic response compared to a non interesterifed, application appropriate fat.

Subjects: Participants will include 40 healthy male and female volunteers aged between the ages of 35 and 75 years (since during this age metabolic changes start to take place).

Power calculation: Based on previous studies carried out by our group at King's College London, a sample size of 20 participants (males and females separately) will allow a 2.16% (percentage unit) difference in FMD to be detected (90% power, 0.05 alpha, SD 2.9. 50 participants will be recruited allowing for a 20% dropout rate.

Expected value:The study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9NH
    • King's College London
  • London, United Kingdom, SE1 9NH
    • Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, Kings College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females aged 35-75 years
• Healthy (free of diagnosed diseases listed in exclusion criteria)
• Able to understand the information sheet and willing to comply with study protocol
• Able to give informed consent

Exclusion Criteria:

• Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes
• Body mass index < 20 kg/m2 or > 35 kg/m2
• Plasma cholesterol ≥7.5 mmol/L
• Plasma triacylglycerol > 3 mmol/L
• Plasma glucose > 7 mmol/L
• Blood pressure ≥140/90 mmHg
• Current use of antihypertensive or lipid lowering medications
• Alcohol intake exceeding a moderate intake (> 28 units per week)
• Current cigarette smoker (or quit within the last 6 months)
• ≥ 20% 10-year risk of CVD as calculated using a risk calculator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interesterified; Commercially available interesterifed fat spread. 50g fat.	Dietary supplement: Interesterified fat; 50 g fat provided as commercially available interesterified fat.
Active Comparator: Non- interesterified; Commercially available non-interesterified fat. 50g fat.	Dietary supplement: Non- interesterified fat; 50 g fat provided as commercially available non-interesterified fat.
Active Comparator: Control; Rapeseed oil. 50 g fat.	Dietary supplement: Rapeseed oil; 50 g fat provided as commercially available rapeseed oil.
Active Comparator: Saturated fat control; Butter. 50g fat	Dietary supplement: Butter; 50g fat provided as commercially available spreadable butter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial function	Flow mediated dilatation	Up to 8 hours
Postprandial lipaemic response	Area under plasma TAG concentration/ time curve	Up to 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial lipaemic response	Postprandial plamsa total fatty acid composition and non esterifed fatty acid	Up to 8 hours
Metabolomic for assessment of atherogenic potential (lipoprotein) analysis	Lipid concentrations and compositions of 14 lipoprotein subclasses, measured by NMR	Up to 8 hours
Glycaemic response	Plasma glucose concentration	Up to 8 hours
Insulinaemic response	Plasma insulin concnetration	Up to 8 hours
Nitric oxide bioavailability	Plasma nitric oxide species and NADPH oxidase activity	Up to 8 hours
Oxidative stress	Plasma 8-isoprostane F2a	Up to 8 hours
Inflammatory response	Plasma IL-6	Up to 8 hours

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Lipid; Postprandial; Interesterified
• Other Study ID Numbers: HR-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No