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

About this trial
This is an interventional basic science trial for Inflammation
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.
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
NCT ID
NCT02587507
First Posted
October 22, 2015
Last Updated
July 27, 2016
Sponsor
University of Sao Paulo
Collaborators
The Scripps Research Institute
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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