AtherosclerosisLipophage14NCT02101346
A Human In Vivo Feeding Study Of The Blood Monocyte Response To Dietary Lipid Intake
A study testing Mixed High Fat Diet, Saturated fat diet and Monounsaturated fat diet in people with Atherosclerosis, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Mixed High Fat Diet, Saturated fat diet and Monounsaturated fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy men
- aged between 18-65 years (inclusive)
- body mass index of between 18.5-25kg/m2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Mixed High Fat Diet, Saturated fat diet, Monounsaturated fat diet, Polyunsaturated fat diet, Triolein 13C
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed High Fat DietDietary supplement
Also called HFD
Healthy, Round 1
Saturated fat dietDietary supplement
Also called SF
Healthy, Round 1 Healthy, Round 2
Monounsaturated fat dietDietary supplement
Also called MUFA
Healthy, Round 1
Polyunsaturated fat dietDietary supplement
Also called PUFA
Healthy, Round 1
Triolein 13CDietary supplement
Also called 13C Tr
Healthy, Round 2
Low fatDietary supplement
Also called LF
Healthy, Round 1
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Saturated fat diet; Dietary Supplement: Triolein 13C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (2)
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).
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Change in scientific information obtained resulting in early cessation of protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin J Woollard, BSc MSc PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101346
- Sponsor's protocol ID
- Lipophage-14
- Acronym
- Lipophage14
- Status last verified
- May 2019
- First submitted
- 13 Mar 2014
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human In Vivo Feeding Study Of The Blood Monocyte Response To Dietary Lipid Intake
- ClinicalTrials.gov ID
- NCT02101346
- Acronym / sponsor ID
- Lipophage14 / Lipophage-14
- Conditions
- Atherosclerosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in scientific information obtained resulting in early cessation of protocol.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy, Round 1 | Experimental | Dietary Supplement: Mixed High Fat Diet, Dietary Supplement: Saturated fat diet, Dietary Supplement: Monounsaturated fat diet, Dietary Supplement: Polyunsaturated fat diet, Dietary Supplement: Low fatFor 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 |
| Healthy, Round 2 | Experimental | Dietary Supplement: Saturated fat diet, Dietary Supplement: Triolein 13CFor feeding of 2 different fatty meals, in order to assess the molecular monocyte response and track the fate of fats. Saturated fat Triolein 13C |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy men
- aged between 18-65 years (inclusive)
- body mass index of between 18.5-25kg/m2
Key exclusion criteria (8 listed)
- Female
- Undiagnosed metabolic syndrome (assessed at initial screening)
- Current smokers
- Substance abuse
- Excess alcohol intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed High Fat DietAlso: HFDHealthy, Round 1 | Dietary supplement | Healthy, Round 1 |
| Saturated fat dietAlso: SFHealthy, Round 1 Healthy, Round 2 | Dietary supplement | Healthy, Round 1, Healthy, Round 2 |
| Monounsaturated fat dietAlso: MUFAHealthy, Round 1 | Dietary supplement | Healthy, Round 1 |
| Polyunsaturated fat dietAlso: PUFAHealthy, Round 1 | Dietary supplement | Healthy, Round 1 |
| Triolein 13CAlso: 13C TrHealthy, Round 2 | Dietary supplement | Healthy, Round 2 |
| Low fatAlso: LFHealthy, Round 1 | Dietary supplement | Healthy, Round 1 |
Primary outcome
Change in ICAM-1 expression by monocytes
Time frame: 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.
2 secondary outcomes
Intracellular lipid volume
Time frame: 3 years
Quantity of dietary fatty acid within postprandial monocytes
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Change in scientific information obtained resulting in early cessation of protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin J Woollard, BSc MSc PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed High Fat Diet, Saturated fat diet and Monounsaturated fat diet in people with Atherosclerosis, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in scientific information obtained resulting in early cessation of protocol.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ICAM-1 expression by monocytes (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.