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

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lipid Intake
Glucose intake
Protein intake
Sponsored by
King Saud Bin Abdulaziz University for Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atherosclerosis focused on measuring Mononuclear cells, Whey proteins, Metabolically-Activated Macrophage, Macrophage Polarization, Macronutrients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Lipid intake

    Glucose intake

    Protein intake

    Arm 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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Detection of markers of M1 and M2 macrophages
    The following markers were used to detect M1 and M2 macrophages (M1:CD86, IL-6, CD11c, and CD169, and M2: CD206, CD163, and CD36)

    Secondary Outcome Measures

    Full Information

    First Posted
    May 28, 2017
    Last Updated
    May 31, 2017
    Sponsor
    King Saud Bin Abdulaziz University for Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03173677
    Brief Title
    Macrophage Polarization in Response to Macronutrient Intake in Healthy Humans: A Randomized Clinical Study
    Official Title
    Monocyte Differentiation and Macrophage Polarization in Circulation in Response to Macronutrient Intake in Healthy Humans: A Randomized Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2, 2016 (Actual)
    Primary Completion Date
    April 24, 2016 (Actual)
    Study Completion Date
    April 29, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Saud Bin Abdulaziz University for Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atherosclerosis
    Keywords
    Mononuclear cells, Whey proteins, Metabolically-Activated Macrophage, Macrophage Polarization, Macronutrients

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lipid intake
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Glucose intake
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Protein intake
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lipid Intake
    Intervention Description
    90 grams whipping cream, 31.5 grams fat, 1.7 grams protein, and 2.25 grams carbohydrate
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Glucose intake
    Intervention Description
    300 calories of glucose
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Protein intake
    Intervention Description
    Isopure unflavored Whey proteins isolate (WPI) powder containing 26 grams per serving of 100% WPI, stripped of fat, carbs, fillers, sugars, and lactose
    Primary Outcome Measure Information:
    Title
    Detection of markers of M1 and M2 macrophages
    Description
    The following markers were used to detect M1 and M2 macrophages (M1:CD86, IL-6, CD11c, and CD169, and M2: CD206, CD163, and CD36)
    Time Frame
    Subject 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 intake

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Awad Alshahrani, MD
    Organizational Affiliation
    Ministry of Natioanl Guard Health Affairs
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Macrophage Polarization in Response to Macronutrient Intake in Healthy Humans: A Randomized Clinical Study

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