The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- King's College London
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Area under plasma TAG concentration/ time curve
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control
Rapeseed oil. 50g fat.
Intervention: Rapeseed oil (Dietary Supplement)
Interesterified
Interesterified blend of palm kernal and plam stearin. 50g fat.
Intervention: Interesterified blend of palm kernal and plam stearin (Dietary Supplement)
Un-interesterified
Un-interesterified blend of palm kernal and plam stearin. 50g fat.
Intervention: Un-interesterified blend of palm kernal and plam stearin (Dietary Supplement)
Outcomes
Primary Outcomes
Area under plasma TAG concentration/ time curve
Time Frame: Up to 8 hours
Postprandial area under plasma TAG concentration/ time curve
Secondary Outcomes
- Positional composition retention (chylomicron)(Up to 6 hours)
- Postprandial lipaemic response(Up to 8 hours)