NCT03173677

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2016

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
Last Updated

June 2, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

May 28, 2017

Last Update Submit

May 31, 2017

Conditions

Atherosclerosis

Keywords

Mononuclear cellsWhey proteinsMetabolically-Activated MacrophageMacrophage PolarizationMacronutrients

Outcome Measures

Primary Outcomes (1)

  • 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)

    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

Study Arms (3)

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.

Dietary Supplement: Lipid Intake

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.

Dietary Supplement: Glucose intake

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.

Dietary Supplement: Protein intake

Interventions

Lipid IntakeDIETARY_SUPPLEMENT

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

Lipid intake
Glucose intakeDIETARY_SUPPLEMENT

300 calories of glucose

Glucose intake
Protein intakeDIETARY_SUPPLEMENT

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

Protein intake

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Renal disease
  • Hepatic disease
  • Cardiovascular disease
  • Using multivitamins
  • Using NSAIDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Italiani P, Boraschi D. From Monocytes to M1/M2 Macrophages: Phenotypical vs. Functional Differentiation. Front Immunol. 2014 Oct 17;5:514. doi: 10.3389/fimmu.2014.00514. eCollection 2014.

    PMID: 25368618BACKGROUND

  • Martinez FO, Gordon S. The M1 and M2 paradigm of macrophage activation: time for reassessment. F1000Prime Rep. 2014 Mar 3;6:13. doi: 10.12703/P6-13. eCollection 2014.

    PMID: 24669294BACKGROUND

  • Billiau A, Matthys P. Interferon-gamma: a historical perspective. Cytokine Growth Factor Rev. 2009 Apr;20(2):97-113. doi: 10.1016/j.cytogfr.2009.02.004. Epub 2009 Mar 5.

    PMID: 19268625BACKGROUND

  • Guha M, Mackman N. LPS induction of gene expression in human monocytes. Cell Signal. 2001 Feb;13(2):85-94. doi: 10.1016/s0898-6568(00)00149-2.

    PMID: 11257452BACKGROUND

  • Feghali CA, Wright TM. Cytokines in acute and chronic inflammation. Front Biosci. 1997 Jan 1;2:d12-26. doi: 10.2741/a171.

    PMID: 9159205BACKGROUND

  • Stein M, Keshav S, Harris N, Gordon S. Interleukin 4 potently enhances murine macrophage mannose receptor activity: a marker of alternative immunologic macrophage activation. J Exp Med. 1992 Jul 1;176(1):287-92. doi: 10.1084/jem.176.1.287.

    PMID: 1613462BACKGROUND

  • Hotamisligil GS, Shargill NS, Spiegelman BM. Adipose expression of tumor necrosis factor-alpha: direct role in obesity-linked insulin resistance. Science. 1993 Jan 1;259(5091):87-91. doi: 10.1126/science.7678183.

    PMID: 7678183BACKGROUND

  • Visser M, Bouter LM, McQuillan GM, Wener MH, Harris TB. Elevated C-reactive protein levels in overweight and obese adults. JAMA. 1999 Dec 8;282(22):2131-5. doi: 10.1001/jama.282.22.2131.

    PMID: 10591334BACKGROUND

  • Fried SK, Bunkin DA, Greenberg AS. Omental and subcutaneous adipose tissues of obese subjects release interleukin-6: depot difference and regulation by glucocorticoid. J Clin Endocrinol Metab. 1998 Mar;83(3):847-50. doi: 10.1210/jcem.83.3.4660.

    PMID: 9506738BACKGROUND

  • Shoelson SE, Lee J, Goldfine AB. Inflammation and insulin resistance. J Clin Invest. 2006 Jul;116(7):1793-801. doi: 10.1172/JCI29069.

    PMID: 16823477BACKGROUND

  • Stoger JL, Gijbels MJ, van der Velden S, Manca M, van der Loos CM, Biessen EA, Daemen MJ, Lutgens E, de Winther MP. Distribution of macrophage polarization markers in human atherosclerosis. Atherosclerosis. 2012 Dec;225(2):461-8. doi: 10.1016/j.atherosclerosis.2012.09.013. Epub 2012 Sep 26.

    PMID: 23078881BACKGROUND

  • Mohanty P, Ghanim H, Hamouda W, Aljada A, Garg R, Dandona P. Both lipid and protein intakes stimulate increased generation of reactive oxygen species by polymorphonuclear leukocytes and mononuclear cells. Am J Clin Nutr. 2002 Apr;75(4):767-72. doi: 10.1093/ajcn/75.4.767.

    PMID: 11916766BACKGROUND

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Awad Alshahrani, MD

    Ministry of Natioanl Guard Health Affairs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biochemistry

Study Record Dates

First Submitted

May 28, 2017

First Posted

June 2, 2017

Study Start

February 2, 2016

Primary Completion

April 24, 2016

Study Completion

April 29, 2016

Last Updated

June 2, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share