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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587507
• Other study ID #: TMTMNC
• Status: Completed
• Phase: N/A
• First received: October 22, 2015
• Last updated: July 27, 2016
• Start date: June 2015
• Est. completion date: October 2015

Study information

• Verified date: July 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation

Intervention

Other:
• Orange juice
Individuals will consume the HFHC meal with 500mL of orange juice.
• Water
Individuals will consume the HFHC meal with 500mL of water.
• Water with glucose
Individuals will consume the HFHC meal with 500mL of water with glucose.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	The Scripps Research Institute

References & Publications (2)

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. Review. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Blood glucose		before the meal	No
Secondary	Blood glucose		1h after the meal	No
Secondary	Blood glucose		3h after the meal	No
Secondary	Blood glucose		5h after the meal	No
Secondary	Insulin		before the meal	No
Secondary	Insulin		1h after the meal	No
Secondary	Insulin		3h after the meal	No
Secondary	Insulin		5h after the meal	No
Secondary	Lipid profile	total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides	before the meal	No
Secondary	Lipid profile	total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides	1h after the meal	No
Secondary	Lipid profile	total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides	3h after the meal	No
Secondary	Lipid profile	total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides	5h after the meal	No