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A Human In Vivo Feeding Study Of The Blood Monocyte Response To Dietary Lipid Intake (Lipophage14)

Primary Purpose

Atherosclerosis

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mixed High Fat Diet
Saturated fat diet
Monounsaturated fat diet
Polyunsaturated fat diet
Triolein 13C
Low fat
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atherosclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy men
  • aged between 18-65 years (inclusive)
  • body mass index of between 18.5-25kg/m2

Exclusion Criteria:

  • Female
  • Undiagnosed metabolic syndrome (assessed at initial screening)
  • Current smokers
  • Substance abuse
  • Excess alcohol intake
  • Significant medical illness including: diabetes, established cardiovascular disease, cancer, gastrointestinal disease (e.g. inflammatory bowel disease or irritable bowel syndrome), kidney, liver or pancreatic disease or autoimmune or inflammatory disease processes.
  • Taking regular medications
  • Major surgery in last 6 months

Sites / Locations

  • Imperial College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy, Round 1

Healthy, Round 2

Arm Description

For feeding of 5 different fatty acid meals in order to assess the monocyte response ex vivo Mixed high fat diet Low fat diet Saturated fat diet Monounsaturated fat diet Polyunsaturated fat diet

For feeding of 2 different fatty meals, in order to assess the molecular monocyte response and track the fate of fats. Saturated fat Triolein 13C

Outcomes

Primary Outcome Measures

Change in ICAM-1 expression by monocytes
ICAM-1 is a marker of monocyte activation (inflammation). ICAM-1 expression can be measured using flow cytometry techniques to quantify expression and therefore inflammation.

Secondary Outcome Measures

Intracellular lipid volume
Lipid uptake by monocyte subsets will be measured as a % of cell volume by staining monocytes with Oil-red-O for neutral intracellular lipid. The % of cell volume with lipid will be compared between the 5 interventional arms of the trial (mixed high fat, low fat, saturated fat, monounsaturated fat and polyunsaturated fat meals).
Quantity of dietary fatty acid within postprandial monocytes
The quantity of dietary fat incorporated into a monocyte will be measured through the use of isotope labelled dietary fat that will be tracked using gas chromatography to provide an exact quantity of how much intracellular lipid within the monocyte originated from the dietary intervention.

Full Information

First Posted
March 13, 2014
Last Updated
May 15, 2019
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT02101346
Brief Title
A Human In Vivo Feeding Study Of The Blood Monocyte Response To Dietary Lipid Intake
Acronym
Lipophage14
Official Title
A Human In Vivo Feeding Study Of The Blood Monocyte Response To Dietary Lipid Intake
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Change in scientific information obtained resulting in early cessation of protocol.
Study Start Date
October 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the present study is to identify the effects of different dietary fats on the body's immune system and how different types of cells respond. There will be two rounds of recruitment in order to satisfy different aims of the study. In the first round, volunteers will be asked to undergo five separate 1-day assessments where you will be given diets in the form of milkshakes differing in amounts of fats. Volunteers recruited for this round will also be given the opportunity to participate in the second round of recruitment and feeding. A second round of recruitment will then take place to complete recruitment, if required. In the second round, volunteers will be asked to undergo two separate 1-day assessments in the form of milkshakes with differing fats, one of which will contain a tracking label added to the food during preparation. This label is in the form of is a 'stable isotope' and safe to consume (used commonly in some medical tests - see below for further information) and will allow the researchers to later find the food particles within blood cells. During these 1-day assessments blood samples will be collected to identify the impact different diets have on the immune system, specifically monocyte cells thought to play an important role in the development of atherosclerosis, a primary cause of cardiovascular disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy, Round 1
Arm Type
Experimental
Arm Description
For feeding of 5 different fatty acid meals in order to assess the monocyte response ex vivo Mixed high fat diet Low fat diet Saturated fat diet Monounsaturated fat diet Polyunsaturated fat diet
Arm Title
Healthy, Round 2
Arm Type
Experimental
Arm Description
For feeding of 2 different fatty meals, in order to assess the molecular monocyte response and track the fate of fats. Saturated fat Triolein 13C
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixed High Fat Diet
Other Intervention Name(s)
HFD
Intervention Description
Healthy, Round 1
Intervention Type
Dietary Supplement
Intervention Name(s)
Saturated fat diet
Other Intervention Name(s)
SF
Intervention Description
Healthy, Round 1 Healthy, Round 2
Intervention Type
Dietary Supplement
Intervention Name(s)
Monounsaturated fat diet
Other Intervention Name(s)
MUFA
Intervention Description
Healthy, Round 1
Intervention Type
Dietary Supplement
Intervention Name(s)
Polyunsaturated fat diet
Other Intervention Name(s)
PUFA
Intervention Description
Healthy, Round 1
Intervention Type
Dietary Supplement
Intervention Name(s)
Triolein 13C
Other Intervention Name(s)
13C Tr
Intervention Description
Healthy, Round 2
Intervention Type
Dietary Supplement
Intervention Name(s)
Low fat
Other Intervention Name(s)
LF
Intervention Description
Healthy, Round 1
Primary Outcome Measure Information:
Title
Change in ICAM-1 expression by monocytes
Description
ICAM-1 is a marker of monocyte activation (inflammation). ICAM-1 expression can be measured using flow cytometry techniques to quantify expression and therefore inflammation.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Intracellular lipid volume
Description
Lipid uptake by monocyte subsets will be measured as a % of cell volume by staining monocytes with Oil-red-O for neutral intracellular lipid. The % of cell volume with lipid will be compared between the 5 interventional arms of the trial (mixed high fat, low fat, saturated fat, monounsaturated fat and polyunsaturated fat meals).
Time Frame
3 years
Title
Quantity of dietary fatty acid within postprandial monocytes
Description
The quantity of dietary fat incorporated into a monocyte will be measured through the use of isotope labelled dietary fat that will be tracked using gas chromatography to provide an exact quantity of how much intracellular lipid within the monocyte originated from the dietary intervention.
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy men aged between 18-65 years (inclusive) body mass index of between 18.5-25kg/m2 Exclusion Criteria: Female Undiagnosed metabolic syndrome (assessed at initial screening) Current smokers Substance abuse Excess alcohol intake Significant medical illness including: diabetes, established cardiovascular disease, cancer, gastrointestinal disease (e.g. inflammatory bowel disease or irritable bowel syndrome), kidney, liver or pancreatic disease or autoimmune or inflammatory disease processes. Taking regular medications Major surgery in last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin J Woollard, BSc MSc PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom

12. IPD Sharing Statement

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A Human In Vivo Feeding Study Of The Blood Monocyte Response To Dietary Lipid Intake

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