Identification of New Biomarkers of Banana and Tomato Intake (BioBanaTom)

July 12, 2018 updated by: Claudine MANACH
The intake of fruits and vegetables has been associated to a lower risk of developing metabolic diseases and cancer. The intake of tomato has been proposed to decrease the risk of prostate cancer while the high content of pro-vitamine A carotenes in banana have shown to alleviate Vitamin A deficiency in different countries. Interestingly in spite of their popularity, there are no biomarkers of banana intake reported in the literature while lycopene is the most frequently used metabolite to indicate tomato consumption however, its limited specificity and between-subjects variation sets doubt of its accuracy. Therefore, the identification of novel biomarkers for both banana and tomato is of great value. Untargeted metabolomics, allows a holistic analysis of the food metabolome allowing a deeper inquiry in the metabolism of different compounds and the recognition of patterns and individual differences that may lead to new hypothesis and further research. Therefore, the aim of the present study is to identify biomarkers of acute intake of banana and tomato using an untargeted approach on urine serum of 12 volunteers that participated in a crossover, randomized, controlled study. Volunteers consumed three different test foods: 1) 240g of banana, 2) 300g of tomato and 3) Fresubin 2kcal as control. Serum and urine samples were collected in kinetics over 24h and processed to be analyzed using LC-QTof analysis. The metabolomics profiles are compared using univariate (ANOVA) and multivariate statistical methods (PCA, PLSDA). The identification of discriminant compounds was performed by tandem mass fragmentation with a high-resolution LTQ-Orbitrab Mass spectrometer and by an extensive inquiry of different online databases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The rise of metabolomics along with different platforms such as liquid chromatography mass spectrometers (LC-MS) have allowed the assessment of thousands of metabolites simultaneously in biological samples and the recognition of patterns that may constitute a fingerprint of the intake of different foods. Recent studies demonstrated the great potential of metabolomics to discover new biomarkers of intake in intervention and cohort studies.The diversity of compounds found in food metabolomics represents a major challenge and so in an international effort to improve dietary biomarkers identification and validation, the Food Biomarkers Alliance (FOODBALL) has been created. In this project, 22 institutions from 11 different countries will collaborate in three main tasks: 1) Discovery of new dietary biomarker using a metabolomic approach, 2) systemic validation of existing and newly discovered biomarker to achieve a good coverage of food intake in different European populations and 3) exploring biological effects using biomarkers of intake (http://foodmetabolome.org/). With the latter, the necessity of building a chemical library that allows the use of standards for further identification arises. Along with FOODBALL, The Food Compound Exchange (FoodComEx) aims to improve the availability of analytical standards of biological compounds to achieve a better and easier biomarker identification (http://foodcomex.org/).

As part of INRA collaboration to FOODBALL and FoodComEx, the present project attempts to identify biomarkers of banana and tomato intake, through the exploration of the serum and urine metabolome of 12 subjects who consumed these foods following a randomized, controlled, crossover design. The present study was comprised of 3 different intervention periods and a minimum of 3 days washout between interventions. The intervention periods were comprised of 2 run in days, 1 intervention day and 1 post intervention day. In the first day of the run in period, subjects were instructed to avoid the intake of banana or tomato or any of their products; the day prior to the intervention volunteers were asked to avoid the intake of phytochemical rich foods and beverages such as wine, coffee, chocolate, tea, and other plant based foods including banana and tomato.In the morning of the intervention, day subjects arrived in fasting state to the research center at 7.30 am. Volunteers were randomly assigned to one of the three interventions, Fresubin ® 2kcal fiber, 240g of banana plus control drink, or 300g of tomato plus control drink plus 12g of refined sunflower oil. Throughout the intervention, subjects had free access to water, maximum 250ml of water per hour until 6 hours after the intake of the test food.

A trained phlebotomist placed a catheter on the subject's arm before the intake of the test foods to collect the baseline sample. Then four other samples were collected postprandially after 1h, 2h, 4h, and 6h. A total of 7 urine samples were collected. The first void of urine was collected by the subjects at home upon the morning of Day 3 and the rest of the samples after the intake of the test foods as follows: 0-1h, 1h-2h, 2h-4h, 4h-6h. The urine samples corresponding to 6h-12h and 12-24h interval were collected by volunteers at home until the morning after the intake of the food.

After the 6h collection of blood, the peripheral catheter was removed and subjects had lunch composed of white bread and cooked pasta, then subjects were allowed to go home. Before leaving the Investigation center, participants were instructed to prepare a standardized dinner based on pan fried chicken with butter and boiled rice with salt. Volunteers were not allowed to eat or drink anything except water and the standardized dinner.

On the morning of the post intervention day, subjects arrived in fasting state to the research center to give the 24h blood sample and deliver the 06-12h and 12-24h urine collection. Afterward, subjects were served breakfast at the research center and resumed their normal diet until the next run in days of the next intervention period.

Urine samples and serum samples were aliquoted and stored at -80° C until analysis.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhône-Alpes-Auvergne
      • Clermont-Ferrand, Rhône-Alpes-Auvergne, France, 63122
        • INRA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and females
  • Aged 18- 40 years
  • BMI >18.5 and < 30 kg/m2
  • Willing/able to consume all test foods (tomato, banana, Fresubin drink) and the standardized meals (rice and chicken)

Exclusion Criteria:

  • Smokers
  • Diagnosed health condition (chronic or infectious disease)
  • Taking nutritional supplements (e.g. vitamins, minerals) several times a week.
  • Taking medication (oral contraceptive pill is allowed).
  • Pregnant, lactating.
  • Antibiotics treatment within 3 months prior to intervention.
  • Vegetarians, as standardized meals will contain meat.
  • Not willing to follow nutritional restrictions, including drinking alcohol during study days
  • Not willing/able to give informed consent or to sign informed consent.
  • Not affiliated to National Health Insurance.
  • Being in exclusion on the National Volunteers Data file or refusing to be registered on the National Volunteers Data file.
  • Currently participating or who having got 4500€ in this year to have participated in another clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Banana Cavendish
240g of fruit plus 150ml of Fresubin ® 2kcal fiber neutral flavor
Other: Banana Cavendish
240g of fruit plus 150ml of control drink (Fresubin ® 2kcal fiber neutral flavor)
Other Names:
  • Test Food
Experimental: Control drink
250ml of Fresubin ® 2kcal fiber neutral flavor
Other: Fresubin ® 2kcal fiber neutral flavor
250 ml Fresubin ® 2kcal fiber neutral flavor
Other Names:
  • Control
Experimental: Tomato
300g of tomato plus of Fresubin ® 2kcal fiber neutral flavor plus 12g of refined sunflower oil.
Other: Tomato
300g of raw tomato ("coeur de boeuf") with refined sunflower oil (12g) and 150ml of control drink (Fresubin ® 2kcal fiber neutral flavor).
Other Names:
  • Test Food

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in metabolite profiles present in blood serum and urine before the dietary intervention (t=0) and in kinetics over 24 hours.
Time Frame: 0-24 hours
Metabolite profiles analyzed using a non-targeted metabolomics approach with a UPLC-MS platform. Blood serum samples collected at time 0, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours. Urine fractions collected at 0-1 hours, 1-2 hours, 2-4 hours, 4-6 hours, 6-12 hours, 12-24 hours. Identification of biomarkers of acute intake of the foods of interest through the comparison of metabolomes after either single dose of tomato, banana or control drink.
0-24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of pools of urine and serum samples after acute intake of tomato or banana to be used as analytical standards or for the identification of specific metabolites of banana or tomato components.
Time Frame: 0-24 hours
The collection of pools of biofluids that result from this study may be shared with the scientific community through the FoodComEx library in order to be used as an analytical standard or for the identification of metabolites that are specific of banana or tomato intake.
0-24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Claudine MANACH

Collaborators

National Research Agency, France

Investigators

  • Principal Investigator: Claudine Manach, Researcher, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2016

Primary Completion (Actual)

May 19, 2016

Study Completion (Actual)

June 16, 2016

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-A00153-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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