The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety (INTERFAT)

The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety: a Randomised Controlled Trial. The INTER-FAT Study

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

Study Overview

• Status: Completed
• Conditions: Healthy Men
• Intervention / Treatment: Dietary supplement: Interesterified blend of palm kernal and plam stearin; Dietary supplement: Un-interesterified blend of palm kernal and plam stearin

Detailed Description

Aim: The current study aims to investigate the acute effects of commercially relevant interesterified 'hardstock' versus the corresponding un-interesterified blend on postprandial lipaemia, glycaemia, insulinaemia and gut hormone responses. Due to the previously observed differences in gut hormones following interesterified palm oil and un-interesterified palm oil by our group, we will also explore acute effects of these fats on satiety and rates of gastric emptying.

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 TAG (but the same fatty acid composition), will alter postprandial lipid and glucose metabolism. It is also hypothesised that differences in rates of absorption between the test fats will influence gut hormone responses and feelings of satiety.

Subjects: Participants will include 10 healthy male volunteers. In order to determine the 'typical' response to the test fats, subjects must not be affected by metabolic syndrome in any way (obesity, dyslipidemia, insulin resistance or hypertension), they must be non-smokers (since smoking influences postprandial lipaemia), and be aged between the ages of 18 and 45 years (since above this age metabolic changes may take place that may affect the way that the body digests and metabolises lipids). Male volunteers have been selected as they elicit a higher postprandial lipaemic response to a given fat load and therefore are more sensitive to dietary manipulation.

Power calculation: A sample size of 10 has 80% power to detect a difference between means of 112.74 units in area under the curve in plasma TAG with a significance level (alpha) of 0.05 (two-tailed).

Expected value:

The study will provide novel information on the acute effects of commercially relevant spreads on postprandial lipaemia and satiety. It will also explore possible mechanisms for the predicted reduced lipaemia following the interesterified fat from measurements of gastric emptying.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9NH
    • Diabetes and Nutritional Sciences Division, School of Medicine, Kings College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Age: 18-45
2. Male
3. Healthy (free of diagnosed diseases listed in exclusion criteria)
4. Able to understand the information sheet and willing to comply with study protocol
5. Able to give informed consent

Exclusion criteria:

1. Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes
2. Body mass index < 20 kg/m2 or > 35 kg/m2
3. Plasma cholesterol ≥7.5 mmol/L
4. Plasma triacylglycerol > 3 mmol/L
5. Plasma glucose > 7 mmol/L
6. Blood pressure ≥160/100 mmHg
7. Current use of antihypertensive or lipid lowering medications
8. Alcohol intake exceeding a moderate intake (> 28 units per week)
9. Current cigarette smoker
10. ≥ 20% 10-year risk of cardiovascular disease as calculated using risk calculator
11. Ingestion of paracetamol in the preceding 24 hrs to study days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interesterified; Interesterified blend of palm kernal and plam stearin. 50g fat.	Dietary supplement: Interesterified blend of palm kernal and plam stearin; 50g fat provided as interesterified palm kernal and palm sterin blend in a single meal; Other Names: Interesterified blend
Active Comparator: Un-interesterified; Un-interesterified blend of palm kernal and plam stearin. 50g fat.	Dietary supplement: Un-interesterified blend of palm kernal and plam stearin; 50g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal; Other Names: Un-interesterified blend

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial lipaemia (Postprandial plasma triacylglycerol concentrations)	Postprandial plasma triacylglycerol concentrations	Postprandial 4 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemia (Postprandial plasma glucose and insulin concentrations)	Postprandial plasma glucose and insulin concentrations	Postprandial 4 hrs
Gut hormones (Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations)	Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations	Postprandial 4 hrs

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satiety (Postprandial visual analogue scales)	Postprandial visual analogue scales	Postprandial 4 hrs
Gastric emptying (Postprandial paracetamol concentrations)	Postprandial paracetamol concentrations	Postprandial 4 hrs

Collaborators and Investigators

• Sponsor: King's College London
• Investigators: Principal Investigator: Sarah EE Berry, BSc,MSc,PhD, King's College London

Publications and helpful links

General Publications

• Hall WL, Iqbal S, Li H, Gray R, Berry SEE. Modulation of postprandial lipaemia by a single meal containing a commonly consumed interesterified palmitic acid-rich fat blend compared to a non-interesterified equivalent. Eur J Nutr. 2017 Dec;56(8):2487-2495. doi: 10.1007/s00394-016-1284-z. Epub 2016 Aug 10.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 11, 2015
• First Submitted That Met QC Criteria: February 18, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: postprandial; interesterified
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: BDM/14/15-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No