Postprandial Monocyte Study

NCT05792137 | Completed

• 1 other identifier: 1999385
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Immune System; Nutrition; Inflammation

Keywords

monocyte; postprandial; nonclassical monocytes

Outcome Measures

Primary Outcomes (1)

• 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 from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days

Secondary Outcomes (38)

• Change in white blood cell count

  Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days

• Change in lymphocyte count

  Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days

• Change in monocyte count

  Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days

• Change in change in neutrophil granulocyte count

  Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days

• Change in eosinophil count

  Measured from samples taken at 0 hours (fasting) and 6 hours (postprandial) on 2 test days

Study Arms (2)

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

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

Other: High saturated fat challenge meal; Other: High mono unsaturated fat challenge meal

Interventions

High saturated fat challenge meal OTHER

High saturated fat challenge meal made with palm oil

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 meal OTHER

High mono unsaturated fat challenge meal made with olive oil

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

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18.5 - 29.9 kg/m²
• have a bank account and social security number or taxpayer identification for financial compensation

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead

Study Sites (1)

USDA Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ryan Snodgrass, PhD

  USDA, Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 31, 2023
• Study Start: November 14, 2023
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)