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Macrophage Polarization in Response to Macronutrient Intake in Healthy Humans: A Randomized Clinical Study

Monocyte Differentiation and Macrophage Polarization in Circulation in Response to Macronutrient Intake in Healthy Humans: A Randomized Clinical Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03173677
Enrollment
36
Registered
2017-06-02
Start date
2016-02-02
Completion date
2016-04-29
Last updated
2017-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Keywords

Mononuclear cells, Whey proteins, Metabolically-Activated Macrophage, Macrophage Polarization, Macronutrients

Brief summary

Macrophages can exhibit distinct phenotypes and functions in response to stimuli and can polarize into one of three distinct phenotypes: a pro-inflammatory (M1), an anti-inflammatory pro-tissue (M2) and metabolically-activated (MMe) macrophage phenotypes. Thirty-six healthy volunteers were recruited and randomized into one of three macronutrient intake groups (glucose, lipids, proteins). This study measured the effects of macronutrient intake on the macrophage differentiation.

Detailed description

Thirty-six normal healthy adult volunteers of normal weight were recruited into the study. All were normotensive, had a normal lipid profile, normal renal and liver function tests, and were not on any medications. All subjects gave their written, informed consent. Institutional Review Board (IRB) of the Ministry of National Guard Health Affairs (MNGHA) approved the study protocol. The 36 participants were randomly assigned by the primary investigator (PI) following simple randomization procedure (computerized random numbers) to three different groups, each received one type of macronutrient (Glucose, whey proteins or lipids). Following an overnight fast, a baseline blood sample was taken. Subjects were then given either 300 calories of glucose (NERL Trutol 75) or lipids (90 grams whipping cream, 31.5 grams fat, 1.7 grams protein and 2.25 grams carbohydrate) or protein (Isopure unflavored Whey proteins isolate (WPI) powder containing 26 grams per serving of 100% WPI, stripped of fat, carbs, fillers, sugars and lactose) solution over 5 minutes. Cream and protein preparations were diluted with water up to 300 mL solutions. Further blood samples were obtained at 1, 2 and 3 hours after the macronutrient intake. Subjects, either one week before or after the macronutrient challenge, were given 300 mL of water to drink in the fasting state. Blood samples were obtained before and at 1, 2 and 3 h after water intake as well. Each subject served as his/her own control and was randomly given macronutrient or water intake.

Interventions

DIETARY_SUPPLEMENTLipid Intake

90 grams whipping cream, 31.5 grams fat, 1.7 grams protein, and 2.25 grams carbohydrate

DIETARY_SUPPLEMENTGlucose intake

300 calories of glucose

DIETARY_SUPPLEMENTProtein intake

Isopure unflavored Whey proteins isolate (WPI) powder containing 26 grams per serving of 100% WPI, stripped of fat, carbs, fillers, sugars, and lactose

Sponsors

King Saud Bin Abdulaziz University for Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Normal weight (BMI 18.5-25) * Healthy adults evident by: physical examination, normal lipid profile, normal renal and liver function tests.

Exclusion criteria

* Renal disease * Hepatic disease * Cardiovascular disease * Using multivitamins * Using NSAIDS

Design outcomes

Primary

MeasureTime frameDescription
Detection of markers of M1 and M2 macrophagesSubject recruitment, enrollment and sample collection were carried out in a period of 3 months. Baseline blood samples were drawn before the caloric or water intake, and subsequent blood samples were drawn at 1-, 2- and 3-hour intervals post the intakeThe following markers were used to detect M1 and M2 macrophages (M1:CD86, IL-6, CD11c, and CD169, and M2: CD206, CD163, and CD36)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026