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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism

Conditions
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Healthy Adults, Postmenopausal Women

Intervention / Treatment
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* Dietary Supplement: Interesterified blend of palm kernal and plam stearin
* Dietary Supplement: Un-interesterified blend of palm kernal and plam stearin
* Dietary Supplement: Rapeseed oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interesterified<br>Interesterified blend of palm kernal and plam stearin. 50g fat. | Dietary Supplement: Interesterified blend of palm kernal and plam stearin<br>* 50 g fat provided as interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)<br>* Other names: Interesterified blend;|
| Active Comparator: Un-interesterified<br>Un-interesterified blend of palm kernal and plam stearin. 50g fat. | Dietary Supplement: Un-interesterified blend of palm kernal and plam stearin<br>* 50 g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)<br>* Other names: Un-interesterified blend;|
| Active Comparator: Control<br>Rapeseed oil. 50g fat. | Dietary Supplement: Rapeseed oil<br>* 50 g fat provided as rapeseed oil in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)<br>* Other names: Control fat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under plasma TAG concentration/ time curve | Postprandial 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 | 
| Positional composition retention (chylomicron) | Postprandial chylomicron TAG concentration and composition, TAG sn-2 fatty acid composition, total protein, apoB100 and apoB48 | Up to 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interesterified, Postprandial, Lipid