Clincosm LogoSign in Get a demo

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

Sponsor
Imperial College London (Other)
Overall Status
Terminated
CT.gov ID
NCT02101346
Collaborator
(none)
8
Enrollment
1
Location
2
Arms
24
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Mixed High Fat Diet
  • Dietary Supplement: Saturated fat diet
  • Dietary Supplement: Monounsaturated fat diet
  • Dietary Supplement: Polyunsaturated fat diet
  • Dietary Supplement: Triolein 13C
  • Dietary Supplement: Low fat
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Human In Vivo Feeding Study Of The Blood Monocyte Response To Dietary Lipid Intake
Actual Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Healthy, Round 1

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

Dietary Supplement: Mixed High Fat Diet
Healthy, Round 1
Other Names:
  • HFD

    • Dietary Supplement: Saturated fat diet
    Healthy, Round 1 Healthy, Round 2
    Other Names:
  • SF

    • Dietary Supplement: Monounsaturated fat diet
    Healthy, Round 1
    Other Names:
  • MUFA

    • Dietary Supplement: Polyunsaturated fat diet
    Healthy, Round 1
    Other Names:
  • PUFA

    • Dietary Supplement: Low fat
    Healthy, Round 1
    Other Names:
  • LF

    		•
    Experimental: Healthy, Round 2

    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

    Dietary Supplement: Saturated fat diet
    Healthy, Round 1 Healthy, Round 2
    Other Names:
  • SF

    • Dietary Supplement: Triolein 13C
    Healthy, Round 2
    Other Names:
  • 13C Tr

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in ICAM-1 expression by monocytes [3 years]

      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

    1. Intracellular lipid volume [3 years]

      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).

    2. Quantity of dietary fatty acid within postprandial monocytes [3 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Imperial College London United Kingdom W12 0NN

    Sponsors and Collaborators

    • Imperial College London

    Investigators

    • Principal Investigator: Kevin J Woollard, BSc MSc PhD, Imperial College London

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imperial College London
    ClinicalTrials.gov Identifier:
    NCT02101346
    Other Study ID Numbers:
    • Lipophage-14
    First Posted:
    Apr 2, 2014
    Last Update Posted:
    May 17, 2019
    Last Verified:
    May 1, 2019
    Additional relevant MeSH terms:
    Atherosclerosis

    Study Results

    No Results Posted as of May 17, 2019