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

Healthy Adults Clinical Trial

— INTER-CARDIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438084
• Other study ID #: HR-
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: August 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Dietary Supplement:
• Interesterified fat
50 g fat provided as commercially available interesterified fat.
• Non- interesterified fat
50 g fat provided as commercially available non-interesterified fat.
• Rapeseed oil
50 g fat provided as commercially available rapeseed oil.
• Butter
50g fat provided as commercially available spreadable butter

Locations

Country	Name	City	State
United Kingdom	Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, Kings College London	London
United Kingdom	King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function	Flow mediated dilatation	Up to 8 hours
Primary	Postprandial lipaemic response	Area under plasma TAG concentration/ time curve	Up to 8 hours
Secondary	Postprandial lipaemic response	Postprandial plamsa total fatty acid composition and non esterifed fatty acid	Up to 8 hours
Secondary	Metabolomic for assessment of atherogenic potential (lipoprotein) analysis	Lipid concentrations and compositions of 14 lipoprotein subclasses, measured by NMR	Up to 8 hours
Secondary	Glycaemic response	Plasma glucose concentration	Up to 8 hours
Secondary	Insulinaemic response	Plasma insulin concnetration	Up to 8 hours
Secondary	Nitric oxide bioavailability	Plasma nitric oxide species and NADPH oxidase activity	Up to 8 hours
Secondary	Oxidative stress	Plasma 8-isoprostane F2a	Up to 8 hours
Secondary	Inflammatory response	Plasma IL-6	Up to 8 hours