Immune SystemPPMSNCT05792137
Postprandial Monocyte Study
A study testing High saturated fat challenge meal and High mono unsaturated fat challenge meal in people with Immune System and Nutrition, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this research is to determine the role of a type of immune cell in blood, called a non-classical monocytes (NCMs), following consumption of a high-fat meal. Previous studies have found that monocytes are important for blood vessel health. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System, Nutrition, Inflammation
- What is being tested?
- High saturated fat challenge meal and High mono unsaturated fat challenge meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2023to 11 Oct 2024
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5 - 29.9 kg/m²
- have a bank account and social security number or taxpayer identification for financial compensation
Who cannot join
- Pregnant or lactating women
- Known allergy or hindering intolerance to study meal ingredients
- Systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg measured
- Fasting glucose above 105 mg/dL
- Triglycerides above 150 mg/dL
- HDL cholesterol less than 40 mg/dL (men) and 50 mg/dL (women)
Show all 21Show fewer
- Self-reported history of difficulties with blood drawing procedures including prior fainting or dizziness, or veins assessed as not suitable for four separate venipunctures by licensed phlebotomist
- Diagnosed active chronic diseases for which the individual is currently taking daily medication, including but not limited to Diabetes mellitus, Cardiovascular disease, Cancer, Gastrointestinal disorders, Kidney disease, Liver disease, Bleeding disorders, Asthma, Autoimmune disorders, Hypertension, Osteoporosis
- Recent minor surgery (within 4 wk) or major surgery (within 16 wk)
- History of gastrointestinal surgery, including gastric bypass surgery or resection
- Recent antibiotic therapy (within 4 wk)
- Known gallbladder disease or history of cholecystectomy
- Recent hospitalization (within 4 wk)
- Use of prescription medications at the time of the study that directly affect endpoints of interest (e.g. hyperlipidemia, glycemic control, steroids, statins, anti-inflammatory agents, and over-the-counter weight loss aids)
- Current participation in another research study
- Less than 18 and over 39 years old
- BMI less than 18.5 and above 29.9 kg/m²
- Has HIV/AIDS or another disease that affects the immune system
- Unable to fast for 12 hours
- Gives regular blood donations and is unwilling to stop during the study
- Has monocytosis (>0.8 x 10³/microliter) or other abnormalities in hematologic parameters based on a screening complete blood count (CBC) with differential
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Western Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Western Human Nutrition Research Center (WHNRC) Postprandial Monocyte Study
The purpose of this research is to determine the role of a type of immune cell in blood, called a non-classical monocytes (NCMs), following consumption of a high-fat meal. Previous studies have found that monocytes are important for blood vessel health. In this study, two different high-fat meals will be used to study the effect of different types of dietary fat on postprandial NCMs. The investigators will characterize NCMs in both fasting conditions and following consumption of two different high-fat meals, and will evaluate whether the type of fat in a meal affects NCMs in blood.
Read the detailed description
Monocytes are a heterogeneous population of circulating blood cells that contribute to tissue integrity as well as to innate and adaptive immune defense. There are three well-characterized subsets based on their relative expression of surface antigens, cluster of differentiation 14 (CD14) and cluster of differentiation 16 (CD16). Monocytes originate from myeloid precursors in the bone marrow and enter the circulation as classical monocytes (CLMs). CLMs represent a transient cell population with a diverse differentiation potential. CLMs comprise 80-90% of the circulating blood monocyte pool and remain in circulation for approximately one day before either migrating into tissue to repopulate the tissue resident macrophage population or maturing into non-classical monocytes (NCMs). NCMs comprise only 5-10% of the circulating blood monocyte pool but have a much longer circulating lifespan of approximately 7 days. NCMs exhibit conflicting functions as anti-inflammatory caretakers of vascular tissue and as contributors to the pathogenesis of disease.
Metabolic responses to food consumption influence the risk of cardiometabolic disease. Postprandial glycemia and lipemia modulate vascular health by altering endothelial function and inducing oxidative stress, inflammation, and apoptosis. Consumption of a single high-fat meal increases circulating interleukin 6 (IL-6), enhances expression of monocyte adhesion molecules, reduces flow-mediated dilation, and increases markers of oxidative stress in human subjects. Although NCMs are described as vascular housekeepers with distinct motility and crawling patterns allowing them to actively surveil endothelium and scavenge luminal debris, their role in the postprandial state is currently unknown.
To better understand the function of postprandial NCMs following consumption of a single high-fat mixed macronutrient challenge meal, the investigators propose a study following a crossover design in which participants will consume one of two isocaloric high-fat challenge meals spaced two-weeks apart, a high-saturated fat mixed macronutrient challenge meal or a high-monounsaturated fat mixed macronutrient challenge meal. Blood at fasting and at six hours postprandial will be collected and the proportion of NCMs and their integrin expression will be analyzed by flow cytometry while changes in global gene expression will be measured by RNA-sequencing.
- Conditions
- Immune System, Nutrition, Inflammation
- Being tested
- High saturated fat challenge meal, High mono unsaturated fat challenge meal
- Keywords
- monocyte, postprandial, nonclassical monocytes
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High saturated fat challenge mealOther
High saturated fat challenge meal made with palm oil
High mono unsaturated fat challenge mealOther
High mono unsaturated fat challenge meal made with olive oil
| Study group | Role | What they receive |
|---|---|---|
| High saturated fat challenge meal followed by high mono-unsaturated fat challenge meal | Experimental | High saturated fat mixed macronutrient challenge meal with palm oil followed by high mono-unsaturated fat mixed macronutrient challenge meal with olive oil two weeks later Receives: Other: High saturated fat challenge meal; Other: High mono unsaturated fat challenge meal |
| High mono-unsaturated fat challenge meal followed by high saturated fat challenge meal | Experimental | High mono-unsaturated fat mixed macronutrient challenge meal with olive oil followed by high saturated fat mixed macronutrient challenge meal with palm oil two weeks later Receives: Other: High saturated fat challenge meal; Other: High mono unsaturated fat challenge meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Monocyte subsets
Monocyte subsets will be analyzed using flow cytometry. Subset analysis will be performed by labeling immune cells with anti-cluster of differentiation antigen 45 (anti-CD45), cluster of differentiation antigen 91 (anti-CD91), anti-CD14, and anti-CD16 fluorescently labeled antibodies.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Secondary outcomes (38)
Change in white blood cell count
White blood cell (WBC) count will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in lymphocyte count
Lymphocyte (LY) count will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in monocyte count
Monocyte (MO) count will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in change in neutrophil granulocyte count
Neutrophil granulocyte (NE) count will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in eosinophil count
Eosinophil (EO) count will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in basophil count
Basophil (BA) count will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in red blood cell count
Red blood cell (RBC) count will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in hemoglobin
Hemoglobin (HGB) will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in hematocrit
Hematocrit (HCT) will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in mean corpuscular volume
Mean corpuscular volume (MCV) will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in mean corpuscular hemoglobin
Mean corpuscular hemoglobin (MCH) will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in mean corpuscular hemoglobin concentration
Mean corpuscular hemoglobin concentration (MCHC) will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in red blood cell distribution width
Red blood cell distribution width (RDW) will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in red blood cell distribution width standard deviation
Red blood cell distribution width standard deviation (RDW-SD) will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in platelet count
Platelet (PLT) count will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in mean platelet volume
Mean platelet volume (MPV) will be measured by a DxH 520 Hematology analyzer.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in CD45 gene expression
Transcriptional changes in non-classical and classical monocytes will be measured by RNA-sequencing following the isolation of non-classical monocytes from peripheral blood by fluorescence-activated cell sorting (FACS) using anti-CD45 fluorescently labeled antibodies.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in CD91 gene expression
Transcriptional changes in non-classical and classical monocytes will be measured by RNA-sequencing following the isolation of non-classical monocytes from peripheral blood by fluorescence-activated cell sorting (FACS) using anti-CD91 fluorescently labeled antibodies.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in CD14 gene expression
Transcriptional changes in non-classical and classical monocytes will be measured by RNA-sequencing following the isolation of non-classical monocytes from peripheral blood by fluorescence-activated cell sorting (FACS) using anti-CD14 fluorescently labeled antibodies.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in CD16 gene expression
Transcriptional changes in non-classical and classical monocytes will be measured by RNA-sequencing following the isolation of non-classical monocytes from peripheral blood by fluorescence-activated cell sorting (FACS) using anti-CD16 fluorescently labeled antibodies.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in expression of very late antigen-4
Monocyte adhesion molecule expression of very late antigen-4 (VLA-4) will be assessed using flow cytometry.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in expression of C-X3-C motif chemokine receptor 1
Monocyte adhesion molecule expression of C-X3-C motif chemokine receptor 1 (CX3CR1) will be assessed using flow cytometry.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in expression of Notch2
Monocyte adhesion molecule expression of Notch2 will be assessed using flow cytometry.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in expression of colony stimulating factor 1 receptor
Monocyte adhesion molecule expression of colony stimulating factor 1 receptor (CSFR1) will be assessed using flow cytometry.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in expression of scavenger receptor class B, member 3
Monocyte adhesion molecule expression of scavenger receptor class B, member 3 (CD36) will be assessed using flow cytometry.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in intensity of filamentous-actin
Filamentous-actin (F-actin) intensity will be assessed using phalloidin.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of interleukin-6
Plasma markers of systemic inflammation including interleukin-6 will be measured by ELISA.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of interleukin-8
Plasma markers of systemic inflammation including interleukin-8 will be measured by ELISA.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of C-reactive protein
Acute phase reactants including C-reactive protein (CRP) will be measured by ELISA.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of serum amyloid A
Acute phase reactants including serum amyloid A (SAA) will be measured by ELISA.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of chemokine ligand 2
Chemokines including chemokine ligand 2 will be measured by ELISA.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of 8-isoprostane F2alpha
Plasma markers of oxidative stress including 8-isoprostane F2alpha will be measured by ELISA.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in soluble cluster of differentiation antigen 146
Endothelial activation including soluble cluster of differentiation antigen 146 (CD146) will be measured by ELISA.
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of triglycerides
Lipid-related markers including triglycerides will be measured by auto-analyzer, Cobas Integra 400+ instrument
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of total cholesterol
Lipid-related markers including total cholesterol will be measured by auto-analyzer, Cobas Integra 400+ instrument
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of HDL-cholesterol
Lipid-related markers including HDL-cholesterol (HDL-C) will be measured by auto-analyzer, Cobas Integra 400+ instrument
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of LDL-cholesterol
Lipid-related markers including LDL-cholesterol (LDL-C) will be measured by auto-analyzer, Cobas Integra 400+ instrument
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of glucose
Plasma glucose will be measured by auto-analyzer, Cobas Integra 400+ instrument
Measured: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start14 Nov 2023
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SystemStudies of the same condition, open and under way.
- 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, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ryan Snodgrass, PhD, Principal investigator, USDA, Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792137
- Sponsor's protocol ID
- 1999385
- Acronym
- PPMS
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Western Human Nutrition Research Center (WHNRC) Postprandial Monocyte Study
- ClinicalTrials.gov ID
- NCT05792137
- Acronym / sponsor ID
- PPMS / 1999385
- Conditions
- Immune System, Nutrition, Inflammation
- Keywords
- monocyte, postprandial, nonclassical monocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 31 Mar 2023 (actual)
- 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 purpose of this research is to determine the role of a type of immune cell in blood, called a non-classical monocytes (NCMs), following consumption of a high-fat meal. Previous studies have found that monocytes are important for blood vessel health. In this study, two different high-fat meals will be used to study the effect of different types of dietary fat on postprandial NCMs. The investigators will characterize NCMs in both fasting conditions and following consumption of two different high-fat meals, and will evaluate whether the type of fat in a meal affects NCMs in blood.
Detailed description
Monocytes are a heterogeneous population of circulating blood cells that contribute to tissue integrity as well as to innate and adaptive immune defense. There are three well-characterized subsets based on their relative expression of surface antigens, cluster of differentiation 14 (CD14) and cluster of differentiation 16 (CD16). Monocytes originate from myeloid precursors in the bone marrow and enter the circulation as classical monocytes (CLMs). CLMs represent a transient cell population with a diverse differentiation potential. CLMs comprise 80-90% of the circulating blood monocyte pool and remain in circulation for approximately one day before either migrating into tissue to repopulate the tissue resident macrophage population or maturing into non-classical monocytes (NCMs). NCMs comprise only 5-10% of the circulating blood monocyte pool but have a much longer circulating lifespan of approximately 7 days. NCMs exhibit conflicting functions as anti-inflammatory caretakers of vascular tissue and as contributors to the pathogenesis of disease.
Metabolic responses to food consumption influence the risk of cardiometabolic disease. Postprandial glycemia and lipemia modulate vascular health by altering endothelial function and inducing oxidative stress, inflammation, and apoptosis. Consumption of a single high-fat meal increases circulating interleukin 6 (IL-6), enhances expression of monocyte adhesion molecules, reduces flow-mediated dilation, and increases markers of oxidative stress in human subjects. Although NCMs are described as vascular housekeepers with distinct motility and crawling patterns allowing them to actively surveil endothelium and scavenge luminal debris, their role in the postprandial state is currently unknown.
To better understand the function of postprandial NCMs following consumption of a single high-fat mixed macronutrient challenge meal, the investigators propose a study following a crossover design in which participants will consume one of two isocaloric high-fat challenge meals spaced two-weeks apart, a high-saturated fat mixed macronutrient challenge meal or a high-monounsaturated fat mixed macronutrient challenge meal. Blood at fasting and at six hours postprandial will be collected and the proportion of NCMs and their integrin expression will be analyzed by flow cytometry while changes in global gene expression will be measured by RNA-sequencing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High saturated fat challenge meal followed by high mono-unsaturated fat challenge meal | Experimental | Other: High saturated fat challenge meal, Other: High mono unsaturated fat challenge mealHigh saturated fat mixed macronutrient challenge meal with palm oil followed by high mono-unsaturated fat mixed macronutrient challenge meal with olive oil two weeks later |
| High mono-unsaturated fat challenge meal followed by high saturated fat challenge meal | Experimental | Other: High saturated fat challenge meal, Other: High mono unsaturated fat challenge mealHigh mono-unsaturated fat mixed macronutrient challenge meal with olive oil followed by high saturated fat mixed macronutrient challenge meal with palm oil two weeks later |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18.5 - 29.9 kg/m²
- have a bank account and social security number or taxpayer identification for financial compensation
Key exclusion criteria (21 listed)
- Pregnant or lactating women
- Known allergy or hindering intolerance to study meal ingredients
- Systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg measured
- Fasting glucose above 105 mg/dL
- Triglycerides above 150 mg/dL
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 |
|---|---|---|
| High saturated fat challenge mealHigh saturated fat challenge meal made with palm oil | Other | High mono-unsaturated fat challenge meal followed by high saturated fat challenge meal, High saturated fat challenge meal followed by high mono-unsaturated fat challenge meal |
| High mono unsaturated fat challenge mealHigh mono unsaturated fat challenge meal made with olive oil | Other | High mono-unsaturated fat challenge meal followed by high saturated fat challenge meal, High saturated fat challenge meal followed by high mono-unsaturated fat challenge meal |
Primary outcome
Change in Monocyte subsets
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Monocyte subsets will be analyzed using flow cytometry. Subset analysis will be performed by labeling immune cells with anti-cluster of differentiation antigen 45 (anti-CD45), cluster of differentiation antigen 91 (anti-CD91), anti-CD14, and anti-CD16 fluorescently labeled antibodies.
38 secondary outcomes
Change in white blood cell count
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in lymphocyte count
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in monocyte count
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in change in neutrophil granulocyte count
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in eosinophil count
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in basophil count
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in red blood cell count
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in hemoglobin
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in hematocrit
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in mean corpuscular volume
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in mean corpuscular hemoglobin
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in mean corpuscular hemoglobin concentration
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in red blood cell distribution width
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in red blood cell distribution width standard deviation
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in platelet count
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in mean platelet volume
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in CD45 gene expression
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in CD91 gene expression
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in CD14 gene expression
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in CD16 gene expression
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in expression of very late antigen-4
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in expression of C-X3-C motif chemokine receptor 1
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in expression of Notch2
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in expression of colony stimulating factor 1 receptor
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in expression of scavenger receptor class B, member 3
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in intensity of filamentous-actin
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of interleukin-6
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of interleukin-8
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of C-reactive protein
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of serum amyloid A
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of chemokine ligand 2
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of 8-isoprostane F2alpha
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in soluble cluster of differentiation antigen 146
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of triglycerides
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of total cholesterol
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of HDL-cholesterol
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of LDL-cholesterol
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Change in levels of glucose
Time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP
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.
Ryan Snodgrass, PhD principal investigator
USDA, Western Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High saturated fat challenge meal and High mono unsaturated fat challenge meal in people with Immune System and Nutrition, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
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 2 inclusion and 21 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: finished, as of the sponsor's last update on 12 Mar 2025. 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 States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Monocyte subsets (time frame: Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days). 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 12 Mar 2025.