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

Healthy Adults Clinical Trial

— INTERMET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191513
• Other study ID #: HR-16/17-4397
• Status: Completed
• Phase: N/A
• Start date: June 12, 2017
• Est. completion date: May 27, 2018

Study information

• Verified date: May 2017
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 27, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults
• Postmenopausal Women

Intervention

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

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Isotope lablelled parameters	In sub-group, n=12, postprandial 13C TAG concentration and breath CO2 13C	Up to 8 hours
Other	Lipoprotein particle size and number	Lipoprotein size (LDL, VLDL and HDL) and composition (total and small LDL, large VLDL and total and large HDL) measured by NMR	Up to 8 hours
Other	2 and 3 MCPD and glycidyl esters	Postprandial plasma 2 and 3-monochloropropane-1,2-diol or 3-chloropropane-1,2-diol glycidyl esters	Up to 8 hours
Primary	Area under plasma TAG concentration/ time curve	Postprandial area under plasma TAG concentration/ time curve	Up to 8 hours
Secondary	Postprandial lipaemic response	Postprandial plamsa total fatty acid composition and non esterifed fatty acid	Up to 8 hours
Secondary	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