InflammationNCT02587507
Proteomic Analysis of Mononuclear Cells After a High-Fat, High-Carbohydrate Meal With or Without Orange Juice
A study testing Orange juice, Water and Water with glucose in people with Inflammation, run by University of Sao Paulo.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Orange juice, Water and Water with glucose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- normal weight
- non-vegetarian
Who cannot join
- use of medication
- alcohol consumption,
- intense physical exercise
- pregnant or lactating
- overweight
- obese
- drug abuse
- any disease such as diabetes, inflammatory conditions.
About this study
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
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.
Read the 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.
- Conditions
- Inflammation
- Being tested
- Orange juice, Water, Water with glucose
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juiceOther
Individuals will consume the HFHC meal with 500mL of orange juice.
WaterOther
Individuals will consume the HFHC meal with 500mL of water.
Water with glucoseOther
Individuals will consume the HFHC meal with 500mL of water with glucose.
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | The subjects will ingest the HFHC meal with 500mL of water. Receives: Other: Water |
| Orange juice | Experimental | The subjects will ingest the HFHC meal with 500mL of orange juice. Receives: 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). Receives: Other: Water with glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in protein expression at mononuclear cells of healthy individuals before and after the high fat meal using TMT labeling and mass spectrometry
Measured: before the meal, 1h, 3h and 5h after the meal
Secondary outcomes (12)
Blood glucose
Measured: before the meal
Blood glucose
Measured: 1h after the meal
Blood glucose
Measured: 3h after the meal
Blood glucose
Measured: 5h after the meal
Insulin
Measured: before the meal
Insulin
Measured: 1h after the meal
Insulin
Measured: 3h after the meal
Insulin
Measured: 5h after the meal
Lipid profile
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
Measured: before the meal
Lipid profile
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
Measured: 1h after the meal
Lipid profile
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
Measured: 3h after the meal
Lipid profile
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
Measured: 5h after the meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- The Scripps Research Institute
- Responsible party
- Principal investigator, Daniela Chaves, University of Sao Paulo
- Investigators
- Daniela FS Chaves, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587507
- Sponsor's protocol ID
- TMTMNC
- Status last verified
- Jul 2016
- First submitted
- 22 Oct 2015
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20200256Coelho 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.
PubMed 23417730Chaves 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.
PubMed 28927270
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02587507
- Acronym / sponsor ID
- TMTMNC
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- The Scripps Research Institute
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Other: WaterThe subjects will ingest the HFHC meal with 500mL of water. |
| Orange juice | Experimental | Other: Orange juiceThe subjects will ingest the HFHC meal with 500mL of orange juice. |
| Water with glucose | Active comparator | Other: Water with glucoseThe subjects will ingest the HFHC meal with 500mL of water with glucose (isocaloric control of the orange juice). |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- normal weight
- non-vegetarian
Key exclusion criteria (8 listed)
- use of medication
- alcohol consumption,
- intense physical exercise
- pregnant or lactating
- overweight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange juiceIndividuals will consume the HFHC meal with 500mL of orange juice. | Other | Orange juice |
| WaterIndividuals will consume the HFHC meal with 500mL of water. | Other | Water |
| Water with glucoseIndividuals will consume the HFHC meal with 500mL of water with glucose. | Other | Water with glucose |
Primary outcome
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
12 secondary outcomes
Blood glucose
Time frame: before the meal
Blood glucose
Time frame: 1h after the meal
Blood glucose
Time frame: 3h after the meal
Blood glucose
Time frame: 5h after the meal
Insulin
Time frame: before the meal
Insulin
Time frame: 1h after the meal
Insulin
Time frame: 3h after the meal
Insulin
Time frame: 5h after the meal
Lipid profile
Time frame: before the meal
Lipid profile
Time frame: 1h after the meal
Lipid profile
Time frame: 3h after the meal
Lipid profile
Time frame: 5h after the meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Results publication: PubMed 20200256Ghanim 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.
- Results publication: PubMed 23417730Coelho 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.
- Derived from this study: PubMed 28927270Chaves 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela FS Chaves, PhD principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice, Water and Water with glucose in people with Inflammation, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02587507, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.