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Proteomic Analysis of Mononuclear Cells After a High-Fat, High-Carbohydrate Meal With or Without Orange Juice

Primary Purpose

Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Orange juice
Water
Water with glucose
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy
  • normal weight
  • non-vegetarian

Exclusion Criteria:

  • use of medication
  • alcohol consumption,
  • intense physical exercise
  • pregnant or lactating
  • overweight
  • obese
  • drug abuse
  • any disease such as diabetes, inflammatory conditions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Active Comparator

    Arm Label

    Water

    Orange juice

    Water with glucose

    Arm Description

    The subjects will ingest the HFHC meal with 500mL of water.

    The subjects will ingest the HFHC meal with 500mL of orange juice.

    The subjects will ingest the HFHC meal with 500mL of water with glucose (isocaloric control of the orange juice).

    Outcomes

    Primary Outcome Measures

    Change in protein expression at mononuclear cells of healthy individuals before and after the high fat meal using TMT labeling and mass spectrometry

    Secondary Outcome Measures

    Blood glucose
    Blood glucose
    Blood glucose
    Blood glucose
    Insulin
    Insulin
    Insulin
    Insulin
    Lipid profile
    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
    Lipid profile
    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
    Lipid profile
    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
    Lipid profile
    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides

    Full Information

    First Posted
    October 22, 2015
    Last Updated
    July 27, 2016
    Sponsor
    University of Sao Paulo
    Collaborators
    The Scripps Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02587507
    Brief Title
    Proteomic Analysis of Mononuclear Cells After a High-Fat, High-Carbohydrate Meal With or Without Orange Juice
    Official Title
    Proteomic Analysis of the Peripheral-Blood Mononuclear Cells Response After a High-Fat, High-Carbohydrate Meal With or Without Orange Juice in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    The Scripps Research Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A high-fat, high-carbohydrate meal (HFHC) induces an increase in inflammation in peripheral-blood mononuclear cells in healthy subjects. A few studies have shown that orange juice, when consumed together with the high-fat meal, is able to revert the increase in inflammatory markers. The present study will assess the effect of a single HFHC meal taken with water, orange juice or an isocaloric glucose drink on protein expression in peripheral blood mononuclear cells of healthy individuals. Twelve healthy, normal weight individuals consumed a HFHC meal with water, water with glucose or orange juice in a cross-over design with at least one week interval between the meals. Blood samples were collected before, 1, 3 and 5h after the meals.
    Detailed Description
    BACKGROUND: A high-fat, high-carbohydrate meal (HFHC) induces an increase in inflammation in peripheral-blood mononuclear cells in healthy subjects. A few studies have shown that orange juice, when consumed together with the high-fat meal, is able to revert the increase in inflammatory markers. OBJECTIVES: To study the effect of a single HFHC meal taken with water, orange juice (500ml) or an isocaloric glucose drink on protein expression in peripheral blood mononuclear cells of healthy individuals. DESIGN AND METHODOLOGY: Twelve healthy, normal weight individuals consumed a HFHC meal with water, water with glucose or orange juice in a cross-over design with at least one week interval between the meals. Blood samples were collected before, 1, 3 and 5h after the meals. Blood glucose, insulin and lipid profile were measured. Also, proteome analysis using TMT labeling was performed on peripheral-blood mononuclear cells collected before and at times 3 and 5h after the meal.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Water
    Arm Type
    Placebo Comparator
    Arm Description
    The subjects will ingest the HFHC meal with 500mL of water.
    Arm Title
    Orange juice
    Arm Type
    Experimental
    Arm Description
    The subjects will ingest the HFHC meal with 500mL of orange juice.
    Arm Title
    Water with glucose
    Arm Type
    Active Comparator
    Arm Description
    The subjects will ingest the HFHC meal with 500mL of water with glucose (isocaloric control of the orange juice).
    Intervention Type
    Other
    Intervention Name(s)
    Orange juice
    Intervention Description
    Individuals will consume the HFHC meal with 500mL of orange juice.
    Intervention Type
    Other
    Intervention Name(s)
    Water
    Intervention Description
    Individuals will consume the HFHC meal with 500mL of water.
    Intervention Type
    Other
    Intervention Name(s)
    Water with glucose
    Intervention Description
    Individuals will consume the HFHC meal with 500mL of water with glucose.
    Primary Outcome Measure Information:
    Title
    Change in protein expression at mononuclear cells of healthy individuals before and after the high fat meal using TMT labeling and mass spectrometry
    Time Frame
    before the meal, 1h, 3h and 5h after the meal
    Secondary Outcome Measure Information:
    Title
    Blood glucose
    Time Frame
    before the meal
    Title
    Blood glucose
    Time Frame
    1h after the meal
    Title
    Blood glucose
    Time Frame
    3h after the meal
    Title
    Blood glucose
    Time Frame
    5h after the meal
    Title
    Insulin
    Time Frame
    before the meal
    Title
    Insulin
    Time Frame
    1h after the meal
    Title
    Insulin
    Time Frame
    3h after the meal
    Title
    Insulin
    Time Frame
    5h after the meal
    Title
    Lipid profile
    Description
    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
    Time Frame
    before the meal
    Title
    Lipid profile
    Description
    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
    Time Frame
    1h after the meal
    Title
    Lipid profile
    Description
    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
    Time Frame
    3h after the meal
    Title
    Lipid profile
    Description
    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
    Time Frame
    5h after the meal

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy normal weight non-vegetarian Exclusion Criteria: use of medication alcohol consumption, intense physical exercise pregnant or lactating overweight obese drug abuse any disease such as diabetes, inflammatory conditions.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniela FS Chaves, PhD
    Organizational Affiliation
    University of Sao Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20200256
    Citation
    Ghanim H, Sia CL, Upadhyay M, Korzeniewski K, Viswanathan P, Abuaysheh S, Mohanty P, Dandona P. Orange juice neutralizes the proinflammatory effect of a high-fat, high-carbohydrate meal and prevents endotoxin increase and Toll-like receptor expression. Am J Clin Nutr. 2010 Apr;91(4):940-9. doi: 10.3945/ajcn.2009.28584. Epub 2010 Mar 3. Erratum In: Am J Clin Nutr. 2011 Mar;93(3):674. Upadhyay, Mannish [corrected to Upadhyay, Manish].
    Results Reference
    result
    PubMed Identifier
    23417730
    Citation
    Coelho RC, Hermsdorff HH, Bressan J. Anti-inflammatory properties of orange juice: possible favorable molecular and metabolic effects. Plant Foods Hum Nutr. 2013 Mar;68(1):1-10. doi: 10.1007/s11130-013-0343-3.
    Results Reference
    result
    PubMed Identifier
    28927270
    Citation
    Chaves DFS, Carvalho PC, Brasili E, Rogero MM, Hassimotto NA, Diedrich JK, Moresco JJ, Yates JR 3rd, Lajolo FM. Proteomic Analysis of Peripheral Blood Mononuclear Cells after a High-Fat, High-Carbohydrate Meal with Orange Juice. J Proteome Res. 2017 Nov 3;16(11):4086-4092. doi: 10.1021/acs.jproteome.7b00476.
    Results Reference
    derived

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    Proteomic Analysis of Mononuclear Cells After a High-Fat, High-Carbohydrate Meal With or Without Orange Juice

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