- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02587507
Proteomic Analysis of Mononuclear Cells After a High-Fat, High-Carbohydrate Meal With or Without Orange Juice
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Water
The subjects will ingest the HFHC meal with 500mL of water.
|
Individuals will consume the HFHC meal with 500mL of water.
|
|
Experimental: Orange juice
The subjects will ingest the HFHC meal with 500mL of orange juice.
|
Individuals will consume the HFHC meal with 500mL of orange juice.
|
|
Active Comparator: Water with glucose
The subjects will ingest the HFHC meal with 500mL of water with glucose (isocaloric control of the orange juice).
|
Individuals will consume the HFHC meal with 500mL of water with glucose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
before the meal, 1h, 3h and 5h after the meal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose
Time Frame: before the meal
|
before the meal
|
|
|
Blood glucose
Time Frame: 1h after the meal
|
1h after the meal
|
|
|
Blood glucose
Time Frame: 3h after the meal
|
3h after the meal
|
|
|
Blood glucose
Time Frame: 5h after the meal
|
5h after the meal
|
|
|
Insulin
Time Frame: before the meal
|
before the meal
|
|
|
Insulin
Time Frame: 1h after the meal
|
1h after the meal
|
|
|
Insulin
Time Frame: 3h after the meal
|
3h after the meal
|
|
|
Insulin
Time Frame: 5h after the meal
|
5h after the meal
|
|
|
Lipid profile
Time Frame: before the meal
|
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
|
before the meal
|
|
Lipid profile
Time Frame: 1h after the meal
|
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
|
1h after the meal
|
|
Lipid profile
Time Frame: 3h after the meal
|
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
|
3h after the meal
|
|
Lipid profile
Time Frame: 5h after the meal
|
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
|
5h after the meal
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniela FS Chaves, PhD, University of Sao Paulo
Publications and helpful links
General Publications
- 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].
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMTMNC
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