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NCT Number: NCT02587507

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

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.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orange juice

Other

Individuals will consume the HFHC meal with 500mL of orange juice.

Water

Other

Individuals will consume the HFHC meal with 500mL of water.

Water with glucose

Other

Individuals will consume the HFHC meal with 500mL of water with glucose.

Primary outcomes

  1. 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

Secondary outcomes

  1. Blood glucose

    Time frame: before the meal

  2. Blood glucose

    Time frame: 1h after the meal

  3. Blood glucose

    Time frame: 3h after the meal

  4. Blood glucose

    Time frame: 5h after the meal

  5. Insulin

    Time frame: before the meal

  6. Insulin

    Time frame: 1h after the meal

  7. Insulin

    Time frame: 3h after the meal

  8. Insulin

    Time frame: 5h after the meal

  9. Lipid profile

    Time frame: before the meal

    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides

  10. Lipid profile

    Time frame: 1h after the meal

    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides

  11. Lipid profile

    Time frame: 3h after the meal

    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides

  12. Lipid profile

    Time frame: 5h after the meal

    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • The Scripps Research Institute

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 27, 2015
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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