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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438084
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
King's College London

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Adults Dietary Supplement: Interesterified fat Dietary Supplement: Non- interesterified fat Dietary Supplement: Rapeseed oil Dietary Supplement: Butter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 31, 2019

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




Primary Outcome Measures :
  1. Endothelial function [ Time Frame: Up to 8 hours ]
    Flow mediated dilatation

  2. Postprandial lipaemic response [ Time Frame: Up to 8 hours ]
    Area under plasma TAG concentration/ time curve


Secondary Outcome Measures :
  1. Postprandial lipaemic response [ Time Frame: Up to 8 hours ]
    Postprandial plamsa total fatty acid composition and non esterifed fatty acid

  2. Metabolomic for assessment of atherogenic potential (lipoprotein) analysis [ Time Frame: Up to 8 hours ]
    Lipid concentrations and compositions of 14 lipoprotein subclasses, measured by NMR

  3. Glycaemic response [ Time Frame: Up to 8 hours ]
    Plasma glucose concentration

  4. Insulinaemic response [ Time Frame: Up to 8 hours ]
    Plasma insulin concnetration

  5. Nitric oxide bioavailability [ Time Frame: Up to 8 hours ]
    Plasma nitric oxide species and NADPH oxidase activity

  6. Oxidative stress [ Time Frame: Up to 8 hours ]
    Plasma 8-isoprostane F2a

  7. Inflammatory response [ Time Frame: Up to 8 hours ]
    Plasma IL-6



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438084


Locations
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United Kingdom
Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, Kings College London
London, United Kingdom, SE1 9NH
King's College London
London, United Kingdom, SE1 9NH
Sponsors and Collaborators
King's College London
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03438084    
Other Study ID Numbers: HR-
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
Interesterified
Postprandial
Lipid