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

Imperial College London

Status: Terminated

Conditions: Atherosclerosis

Treatments: Dietary Supplement: Triolein 13C; Dietary Supplement: Polyunsaturated fat diet; Dietary Supplement: Saturated fat diet; Dietary Supplement: Mixed High Fat Diet; Dietary Supplement: Low fat; Dietary Supplement: Monounsaturated fat diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02101346

Lipophage-14

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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8 participants in 2 patient groups

Healthy, Round 1

Experimental group

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

Treatment:

Dietary Supplement: Monounsaturated fat diet

Dietary Supplement: Low fat

Dietary Supplement: Mixed High Fat Diet

Dietary Supplement: Saturated fat diet

Dietary Supplement: Polyunsaturated fat diet

Healthy, Round 2

Experimental group

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

Treatment:

Dietary Supplement: Saturated fat diet

Dietary Supplement: Triolein 13C