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

K

King's College London

Status

Completed

Conditions

Healthy Adults

Treatments

Dietary Supplement: Rapeseed oil
Dietary Supplement: Non- interesterified fat
Dietary Supplement: Interesterified fat
Dietary Supplement: Butter

Study type

Interventional

Funder types

Other

Identifiers

NCT03438084
HR-

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

35 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

50 participants in 4 patient groups

Interesterified
Experimental group
Description:
Commercially available interesterifed fat spread. 50g fat.
Treatment:
Dietary Supplement: Interesterified fat
Non- interesterified
Active Comparator group
Description:
Commercially available non-interesterified fat. 50g fat.
Treatment:
Dietary Supplement: Non- interesterified fat
Control
Active Comparator group
Description:
Rapeseed oil. 50 g fat.
Treatment:
Dietary Supplement: Rapeseed oil
Saturated fat control
Active Comparator group
Description:
Butter. 50g fat
Treatment:
Dietary Supplement: Butter

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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