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

NCT ID: NCT02101346

Last Updated: 2019-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Mixed High Fat Diet

Intervention Type DIETARY_SUPPLEMENT

Healthy, Round 1

Saturated fat diet

Intervention Type DIETARY_SUPPLEMENT

Healthy, Round 1 Healthy, Round 2

Monounsaturated fat diet

Intervention Type DIETARY_SUPPLEMENT

Healthy, Round 1

Polyunsaturated fat diet

Intervention Type DIETARY_SUPPLEMENT

Healthy, Round 1

Low fat

Intervention Type DIETARY_SUPPLEMENT

Healthy, Round 1

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

Group Type EXPERIMENTAL

Saturated fat diet

Intervention Type DIETARY_SUPPLEMENT

Healthy, Round 1 Healthy, Round 2

Triolein 13C

Intervention Type DIETARY_SUPPLEMENT

Healthy, Round 2

Interventions

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Mixed High Fat Diet

Healthy, Round 1

Intervention Type DIETARY_SUPPLEMENT

Saturated fat diet

Healthy, Round 1 Healthy, Round 2

Intervention Type DIETARY_SUPPLEMENT

Monounsaturated fat diet

Healthy, Round 1

Intervention Type DIETARY_SUPPLEMENT

Polyunsaturated fat diet

Healthy, Round 1

Intervention Type DIETARY_SUPPLEMENT

Triolein 13C

Healthy, Round 2

Intervention Type DIETARY_SUPPLEMENT

Low fat

Healthy, Round 1

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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HFD SF MUFA PUFA 13C Tr LF

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin J Woollard, BSc MSc PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Lipophage-14

Identifier Type: -

Identifier Source: org_study_id

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