The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism (INTERMET)

King's College London

Status: Completed

Conditions: Postmenopausal Women; Healthy Adults

Treatments: Dietary Supplement: Rapeseed oil; Dietary Supplement: Interesterified blend of palm kernal and plam stearin; Dietary Supplement: Un-interesterified blend of palm kernal and plam stearin

Study type: Interventional

Funder types: Other

Identifiers

NCT03191513

HR-16/17-4397

Details and patient eligibility

About

The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used commercially versus the corresponding un-interesterified blend.

Full description

Aim: The current study aims to investigate the acute effects of commercially relevant interesterified 'hardstock' versus the corresponding un-interesterified blend on 8 h postprandial fat metabolism.

Hypothesis: Interesterification of a palm kernel and palm stearin fat blend, to produce a fat with a higher proportion of palmitic acid in the middle position of the triglyceride (TAG; but the same fatty acid composition), will alter postprandial lipid metabolism.

Subjects: Participants will include 24 healthy male and female (postmenopausal) volunteers aged between the ages of 45 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 10 males and 10 females is required to detect a (clinically relevant) difference (for males and females separately) between means of 0.3 mmol/L maximal difference in 8 h plasma TAG concentration (standard deviation 0.33 mmol/L, significance level (alpha) of 0.05 and 80% power). 12 males and 12 females will be recruited to allow for a 20% drop out rate.

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

Enrollment: 24 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females aged 45-75 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
• Premenopausal (for women)
• Alcohol intake exceeding a moderate intake (> 28 units per week)
• Current cigarette smoker (or quit withint 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

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24 participants in 3 patient groups

Interesterified

Experimental group

Description:

Interesterified blend of palm kernal and plam stearin. 50g fat.

Treatment:

Dietary Supplement: Interesterified blend of palm kernal and plam stearin

Un-interesterified

Active Comparator group

Description:

Un-interesterified blend of palm kernal and plam stearin. 50g fat.

Treatment:

Dietary Supplement: Un-interesterified blend of palm kernal and plam stearin

Control

Active Comparator group

Description:

Rapeseed oil. 50g fat.

Treatment:

Dietary Supplement: Rapeseed oil