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

Atherosclerosis Clinical Trial

— Lipophage14  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02101346
• Other study ID #: Lipophage-14
• Status: Terminated
• Phase: N/A
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: May 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Dietary Supplement:
• Mixed High Fat Diet
Healthy, Round 1
• Saturated fat diet
Healthy, Round 1 Healthy, Round 2
• Monounsaturated fat diet
Healthy, Round 1
• Polyunsaturated fat diet
Healthy, Round 1
• Triolein 13C
Healthy, Round 2
• Low fat
Healthy, Round 1

Locations

Country	Name	City	State
United Kingdom	Imperial College	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Secondary	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).	3 years
Secondary	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.	3 years