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
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
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
academic
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