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

NCT02101346 | Terminated DMC

• 1 other identifier: Lipophage-14
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intracellular lipid volume

  3 years

• Quantity of dietary fatty acid within postprandial monocytes

  3 years

Study Arms (2)

Healthy, Round 1

EXPERIMENTAL

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; Dietary Supplement: Saturated fat diet; Dietary Supplement: Monounsaturated fat diet; Dietary Supplement: Polyunsaturated fat diet; Dietary Supplement: Low fat

Healthy, Round 2

EXPERIMENTAL

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; Dietary Supplement: Triolein 13C

Interventions

Mixed High Fat Diet DIETARY_SUPPLEMENT

Healthy, Round 1

Also known as: HFD

Healthy, Round 1

Saturated fat diet DIETARY_SUPPLEMENT

Healthy, Round 1 Healthy, Round 2

Also known as: SF

Healthy, Round 1; Healthy, Round 2

Monounsaturated fat diet DIETARY_SUPPLEMENT

Healthy, Round 1

Also known as: MUFA

Healthy, Round 1

Polyunsaturated fat diet DIETARY_SUPPLEMENT

Healthy, Round 1

Also known as: PUFA

Healthy, Round 1

Triolein 13C DIETARY_SUPPLEMENT

Healthy, Round 2

Also known as: 13C Tr

Healthy, Round 2

Low fat DIETARY_SUPPLEMENT

Healthy, Round 1

Also known as: LF

Healthy, Round 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Kevin J Woollard, BSc MSc PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: April 2, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 17, 2019

Record last verified: 2019-05

Locations

GB (1)