Clinical trial NCT02587507: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: The Scripps Research Institute
First posted: 2015-10-27
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in protein expression at mononuclear cells of healthy individuals before and after the high fat meal using TMT labeling and mass spectrometry
timeFrame: before the meal, 1h, 3h and 5h after the meal
Secondary outcomes:
measure: Blood glucose
timeFrame: before the meal
measure: Blood glucose
timeFrame: 1h after the meal
measure: Blood glucose
timeFrame: 3h after the meal
measure: Blood glucose
timeFrame: 5h after the meal
measure: Insulin
timeFrame: before the meal
measure: Insulin
timeFrame: 1h after the meal
measure: Insulin
timeFrame: 3h after the meal
measure: Insulin
timeFrame: 5h after the meal
measure: Lipid profile
timeFrame: before the meal
measure: Lipid profile
timeFrame: 1h after the meal
measure: Lipid profile
timeFrame: 3h after the meal
measure: Lipid profile
timeFrame: 5h after the meal
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Daniela FS Chaves, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.