Condition category
Circulatory System
Date applied
30/06/2018
Date assigned
13/08/2018
Last edited
31/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to analyze the effects of the consumption of oranges on cardiovascular risk biomarkers (biological molecules found in the blood, other body fluids, or tissues that are a sign of heart disease).

Who can participate?
Healthy men and women

What does the study involve?
After a minimum of 8 hours fasting participants are randomly allocated to eat 500 g of peeled oranges or an isocaloric (same energy as the oranges) solution of sucrose in water. No other food is allowed for 4 hours. At the start and after 4 hours blood and urine samples are taken as well as blood pressure and body measurements and questionnaire data. Biomarkers are measured in the blood and urine samples. After a 1-week break the two groups swap over and the study is repeated. In a longer study with a subgroup of the initial volunteers, participants are randomly allocated to be told to either eat oranges every day for a month, or to reduce their intake of oranges for a month. At the start and after 1 month, samples of blood and urine are taken for biomarker measurements.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Valencia (Spain)

When is the study starting and how long is it expected to run for?
April 2015 to December 2019

Who is funding the study?
University of Valencia (Spain)

Who is the main contact?
Prof. Dolores Corella

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dolores Corella

ORCID ID

Contact details

Avda. Blasco Ibanez
15
Valencia
46010
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UV111

Study information

Scientific title

Effects of the consumption of oranges on gene expression and other biomarkers of disease and intake in a healthy population in a randomized intervention trial

Acronym

ORANGOMICS

Study hypothesis

The short-term intake of oranges will have a favorable effect on biochemical markers related with cardiovascular risk, also including gene expression, metabolomic and epigenomic markers. As a secondary aim, metabolomic studies will provide a panel of markers for intake.

Ethics approval

Institutional Review Board of Valencia University (human subjects), 26/03/2015, ref: H1425917369905

Study design

Cross-over randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Effect of eating oranges on cardiovascular disease biomarkers in healthy people

Intervention

For the short-term cross-over randomized trial. In a computer generated random order, 15 of the 30 study participants were assigned to the intervention with oranges. 500 g of peeled oranges were administered after a minimum of 8 h fasting. No other food was administered or ingested during 4 h. The other 15 subjects were the control arm and after a minimum of 8 h fasting received an isocaloric (same energy than the oranges) solution of sucrose in water. No other food was administered of ingested during 4 h. At baseline and after 4 h plasma, urine, serum and buffy coat samples were obtained as well as blood pressure, anthropometric and questionnaire data. The DNA and RNA are isolated. RNA is used for the study of gene expression and biomarkers are determined in plasma and urine samples, including metabolomic analyses. The wash-out period was 1 week and the interventions cross-over.

Subsequently, a longer intervention study is carried out with nutritional advice to increase the consumption of oranges in a subgroup of the initial volunteers. It is a parallel and randomized design of 1 month. Subjects were randomly allocated to two groups (oranges and control group) and the intervention arm consisted of the advice of eating oranges all days during a month. The control arm received advise of a reduced intake of oranges during a month. At baseline and monthly, biological samples of plasma, urine, serum and buffy coat are also taken for subsequent measurements. It is analyzed if the consumption of oranges has a favorable effect on these markers.

In parallel, a metabolomic study is proposed to identify markers of the intake of oranges since the short-term intervention study provides a unique intervention with this food. The subsequent longer-term study along with other foods in the diet will also allow validation of the use of metabolomic markers for consumption of oranges and secondary analyses of metabolomic biomarkers of other foods.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Classical biochemical parameters related to cardiovascular risk at baseline and 4 h/1 month, also including novel omics markers (in plasma and/or urine) analyzed by metabolomics (also including markers of intake), gene expression and other omics

Secondary outcome measures

For the short-term crossover intervention trial, measured at baseline and 4 h:
1. Blood pressure
2. Anthropometric variables (weight, height, waist circumference and body composition by bioimpedance)
3. Genetic polymorphisms
4. Food intake measured by a validated food frequency questionnaire
5. Taste perception tests with standardized tastants for bitter, sour, sweet, umami and salty

For the 1-month intervention, measured at baseline and 1 month:
1. Blood pressure
2. Anthropometric variables (weight, height, waist circumference and body composition by bioimpedance)
3. Genetic polymorphisms

Overall trial start date

01/04/2015

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Healthy men and women

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Diseased
2. Allergic to oranges
3. Immunodeficiency or HIV-positive status
4. Liver cirrhosis or chronic renal failure
5. Serious psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression, etc
6. Any severe co-morbid condition
7. Alcohol abuse or addition
8. History of major organ transplantation
9. Concurrent therapy with immunosuppressive drugs or cytotoxic agents
10. Current treatment with systemic corticosteroids
11. Current use of weight loss medication
12. Patients with an acute infection or inflammation
13. Any other condition that may interfere with the completion of the study protocol

Recruitment start date

05/04/2015

Recruitment end date

05/05/2015

Locations

Countries of recruitment

Spain

Trial participating centre

Universidad de Valencia
Avda. Blasco Ibanez, 13
Valencia
46010
Spain

Sponsor information

Organisation

Universitat de Valencia

Sponsor details

Avda. Blasco Ibanez
13
Valencia
46010
Spain

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Universitat de València

Alternative name(s)

University of Valencia

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

Spain

Results and Publications

Publication and dissemination plan

Publication in international journals and scientific meetings.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as the patients did not provide informed content for sharing.

Intention to publish date

15/09/2018

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes