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

King Saud Bin Abdulaziz University for Health Sciences

Status: Completed

Conditions: Atherosclerosis

Treatments: Dietary Supplement: Protein intake; Dietary Supplement: Glucose intake; Dietary Supplement: Lipid Intake

Study type: Interventional

Funder types: Other

Identifiers

NCT03173677

SP15/026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 3 patient groups

Lipid intake

Active Comparator group

Description:

12 subjects had 300 Calories of lipids or 300 mL of water. Blood samples were drawn at 0, 1, 2, and 3 hrs post intake. There was a one week period between the 2 intakes.

Treatment:

Dietary Supplement: Lipid Intake

Glucose intake

Active Comparator group

Description:

12 subjects had 300 Calories of glucose or 300 mL of water. Blood samples were drawn at 0, 1, 2, and 3 hrs post intake. There was a one week period between the 2 intakes.

Treatment:

Dietary Supplement: Glucose intake

Protein intake

Active Comparator group

Description:

12 subjects had 300 Calories Whey protein intake or 300 mL of water. Blood samples were drawn at 0, 1, 2, and 3 hrs post intake. There was a one week period between the 2 intakes.

Treatment:

Dietary Supplement: Protein intake