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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Proteomic Analysis of the Peripheral-Blood Mononuclear Cells Response After a High-Fat, High-Carbohydrate Meal With or Without Orange Juice in Healthy Subjects

Conditions
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Inflammation

Intervention / Treatment
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* Other: Orange juice
* Other: Water
* Other: Water with glucose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Water<br>The subjects will ingest the HFHC meal with 500mL of water. | Other: Water<br>* Individuals will consume the HFHC meal with 500mL of water.<br>|
| Experimental: Orange juice<br>The subjects will ingest the HFHC meal with 500mL of orange juice. | Other: Orange juice<br>* Individuals will consume the HFHC meal with 500mL of orange juice.<br>|
| Active Comparator: Water with glucose<br>The subjects will ingest the HFHC meal with 500mL of water with glucose (isocaloric control of the orange juice). | Other: Water with glucose<br>* Individuals will consume the HFHC meal with 500mL of water with glucose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | before the meal, 1h, 3h and 5h after the meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose |  | before the meal | 
| Blood glucose |  | 1h after the meal | 
| Blood glucose |  | 3h after the meal | 
| Blood glucose |  | 5h after the meal | 
| Insulin |  | before the meal | 
| Insulin |  | 1h after the meal | 
| Insulin |  | 3h after the meal | 
| Insulin |  | 5h after the meal | 
| Lipid profile | total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides | before the meal | 
| Lipid profile | total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides | 1h after the meal | 
| Lipid profile | total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides | 3h after the meal | 
| Lipid profile | total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides | 5h after the meal |