Trial | NCT03173677  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    glucose ...

  • Study Participants

    36
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.
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.
Study Started
Feb 02
2016
Primary Completion
Apr 24
2016
Study Completion
Apr 29
2016
Last Update
Jun 02
2017

Dietary Supplement Lipid Intake

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

Dietary Supplement Glucose intake

300 calories of glucose

Dietary Supplement Protein intake

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

Lipid intake Active Comparator

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.

Glucose intake Active Comparator

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.

Protein intake Active Comparator

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.

Criteria 

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
No Results Posted