NCT02587507

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

October 22, 2015

Last Update Submit

July 27, 2016

Conditions

Inflammation

Outcome Measures

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

    before the meal, 1h, 3h and 5h after the meal

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (3)

Water

PLACEBO COMPARATOR

The subjects will ingest the HFHC meal with 500mL of water.

Other: Water

Orange juice

EXPERIMENTAL

The subjects will ingest the HFHC meal with 500mL of orange juice.

Other: Orange juice

Water with glucose

ACTIVE COMPARATOR

The subjects will ingest the HFHC meal with 500mL of water with glucose (isocaloric control of the orange juice).

Other: Water with glucose

Interventions

Orange juiceOTHER

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

Orange juice
WaterOTHER

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

Water
Water with glucoseOTHER

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

Water with glucose

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • normal weight
  • non-vegetarian

You may not qualify if:

  • use of medication
  • alcohol consumption,
  • intense physical exercise
  • pregnant or lactating
  • overweight
  • obese
  • drug abuse
  • any disease such as diabetes, inflammatory conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 20200256RESULT

  • 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.

    PMID: 23417730RESULT

  • 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.

    PMID: 28927270DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

WaterGlucose

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Daniela FS Chaves, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 27, 2015

Study Start

June 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

July 29, 2016

Record last verified: 2016-07