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

Primary Purpose

Healthy Men

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Interesterified blend of palm kernal and plam stearin
Un-interesterified blend of palm kernal and plam stearin
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Men focused on measuring interesterified, postprandial

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Diabetes and Nutritional Sciences Division, School of Medicine, Kings College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interesterified

Un-interesterified

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postprandial lipaemia (Postprandial plasma triacylglycerol concentrations)
Postprandial plasma triacylglycerol concentrations

Secondary Outcome Measures

Glycemia (Postprandial plasma glucose and insulin concentrations)
Postprandial plasma glucose and insulin concentrations
Gut hormones (Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations)
Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations

Full Information

First Posted
February 11, 2015
Last Updated
March 7, 2017
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT02365987
Brief Title
The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety
Acronym
INTERFAT
Official Title
The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety: a Randomised Controlled Trial. The INTER-FAT Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Men
Keywords
interesterified, postprandial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interesterified
Arm Type
Experimental
Arm Description
Interesterified blend of palm kernal and plam stearin. 50g fat.
Arm Title
Un-interesterified
Arm Type
Active Comparator
Arm Description
Un-interesterified blend of palm kernal and plam stearin. 50g fat.
Intervention Type
Dietary Supplement
Intervention Name(s)
Interesterified blend of palm kernal and plam stearin
Other Intervention Name(s)
Interesterified blend
Intervention Description
50g fat provided as interesterified palm kernal and palm sterin blend in a single meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Un-interesterified blend of palm kernal and plam stearin
Other Intervention Name(s)
Un-interesterified blend
Intervention Description
50g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal
Primary Outcome Measure Information:
Title
Postprandial lipaemia (Postprandial plasma triacylglycerol concentrations)
Description
Postprandial plasma triacylglycerol concentrations
Time Frame
Postprandial 4 hrs
Secondary Outcome Measure Information:
Title
Glycemia (Postprandial plasma glucose and insulin concentrations)
Description
Postprandial plasma glucose and insulin concentrations
Time Frame
Postprandial 4 hrs
Title
Gut hormones (Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations)
Description
Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations
Time Frame
Postprandial 4 hrs
Other Pre-specified Outcome Measures:
Title
Satiety (Postprandial visual analogue scales)
Description
Postprandial visual analogue scales
Time Frame
Postprandial 4 hrs
Title
Gastric emptying (Postprandial paracetamol concentrations)
Description
Postprandial paracetamol concentrations
Time Frame
Postprandial 4 hrs

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 18-45 Male 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 ≥160/100 mmHg Current use of antihypertensive or lipid lowering medications Alcohol intake exceeding a moderate intake (> 28 units per week) Current cigarette smoker ≥ 20% 10-year risk of cardiovascular disease as calculated using risk calculator Ingestion of paracetamol in the preceding 24 hrs to study days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah EE Berry, BSc,MSc,PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes and Nutritional Sciences Division, School of Medicine, Kings College London
City
London
ZIP/Postal Code
SE1 9NH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27511058
Citation
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.
Results Reference
derived

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

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