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

July 27, 2016 updated by: Daniela Chaves, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniela FS Chaves, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMTMNC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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