BiomarkersBioBanaTomNCT03581955
Identification of New Biomarkers of Banana and Tomato Intake
A study testing Banana Cavendish, Tomato and Fresubin ® 2kcal fiber neutral flavor in people with Biomarkers and Food Intake, run by Claudine MANACH at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomarkers, Food Intake
- What is being tested?
- Banana Cavendish, Tomato and Fresubin ® 2kcal fiber neutral flavor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2016to 16 Jun 2016
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Biomarkers, Food Intake
- Being tested
- Banana Cavendish, Tomato, Fresubin ® 2kcal fiber neutral flavor
- Keywords
- biomarkers, diet, banana, tomato, urine, plasma, intake, exposure, metabolomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Banana CavendishOther
Also called Test Food
240g of fruit plus 150ml of control drink (Fresubin ® 2kcal fiber neutral flavor)
TomatoOther
Also called Test Food
300g of raw tomato ("coeur de boeuf") with refined sunflower oil (12g) and 150ml of control drink (Fresubin ® 2kcal fiber neutral flavor).
Fresubin ® 2kcal fiber neutral flavorOther
Also called Control
250 ml Fresubin ® 2kcal fiber neutral flavor
| Study group | Role | What they receive |
|---|---|---|
| Banana Cavendish | Experimental | 240g of fruit plus 150ml of Fresubin ® 2kcal fiber neutral flavor Receives: Other: Banana Cavendish |
| Control drink | Experimental | 250ml of Fresubin ® 2kcal fiber neutral flavor Receives: Other: Fresubin ® 2kcal fiber neutral flavor |
| Tomato | Experimental | 300g of tomato plus of Fresubin ® 2kcal fiber neutral flavor plus 12g of refined sunflower oil. Receives: Other: Tomato |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in metabolite profiles present in blood serum and urine before the dietary intervention (t=0) and in kinetics over 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.
Measured: 0-24 hours
Secondary outcomes (1)
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.
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.
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start26 Mar 2016
- Primary completion19 May 2016
- Study completion16 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The present project is a randomized, controlled, crossover study with 12 subjects. A cross-over design has been selected as each subject can serve as his/her own control thereby minimizing variations. The intervention order was randomized. The study design does not allow blinding as intervention is the ingestion of different foods.In this study, we assessed the metabolomic profiles of human biofluids after consumption of two different foods: banana (240g peeled fruit) and tomato (300g fresh fruit) in order to identify novel biomarkers for each food. As a control diet, a high energy high protein drink, Fresubin ® 2kcal fiber (Fresinius kabi) was used. The study comprised three dietary interventions of 4 days each and a wash-out period no shorter than 3 days.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudine MANACH
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor-investigator, Claudine MANACH, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Claudine Manach, Researcher, Principal investigator, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581955
- Sponsor's protocol ID
- 2016-A00153-48
- Acronym
- BioBanaTom
- Status last verified
- Jul 2018
- First submitted
- 31 Aug 2017
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andersen MB, Kristensen M, Manach C, Pujos-Guillot E, Poulsen SK, Larsen TM, Astrup A, Dragsted L. Discovery and validation of urinary exposure markers for different plant foods by untargeted metabolomics. Anal Bioanal Chem. 2014 Mar;406(7):1829-44. doi: 10.1007/s00216-013-7498-5. Epub 2014 Jan 4.
PubMed 24390407Manach C, Hubert J, Llorach R, Scalbert A. The complex links between dietary phytochemicals and human health deciphered by metabolomics. Mol Nutr Food Res. 2009 Oct;53(10):1303-15. doi: 10.1002/mnfr.200800516.
PubMed 19764066Scalbert A, Brennan L, Manach C, Andres-Lacueva C, Dragsted LO, Draper J, Rappaport SM, van der Hooft JJ, Wishart DS. The food metabolome: a window over dietary exposure. Am J Clin Nutr. 2014 Jun;99(6):1286-308. doi: 10.3945/ajcn.113.076133. Epub 2014 Apr 23.
PubMed 24760973Re R, Bramley PM, Rice-Evans C. Effects of food processing on flavonoids and lycopene status in a Mediterranean tomato variety. Free Radic Res. 2002 Jul;36(7):803-10. doi: 10.1080/10715760290032584.
PubMed 12180131Giovannucci E. Tomatoes, tomato-based products, lycopene, and cancer: review of the epidemiologic literature. J Natl Cancer Inst. 1999 Feb 17;91(4):317-31. doi: 10.1093/jnci/91.4.317.
PubMed 10050865Pereira A, Maraschin M. Banana (Musa spp) from peel to pulp: ethnopharmacology, source of bioactive compounds and its relevance for human health. J Ethnopharmacol. 2015 Feb 3;160:149-63. doi: 10.1016/j.jep.2014.11.008. Epub 2014 Nov 13.
PubMed 25449450Pujos-Guillot E, Hubert J, Martin JF, Lyan B, Quintana M, Claude S, Chabanas B, Rothwell JA, Bennetau-Pelissero C, Scalbert A, Comte B, Hercberg S, Morand C, Galan P, Manach C. Mass spectrometry-based metabolomics for the discovery of biomarkers of fruit and vegetable intake: citrus fruit as a case study. J Proteome Res. 2013 Apr 5;12(4):1645-59. doi: 10.1021/pr300997c. Epub 2013 Mar 5.
PubMed 23425595Peralta I, Spooner DM. Genetic Improvement of Solanaceous Crops Volume 2: Tomato. CRC Press; 2006. https://books.google.com/books?hl=en&lr=&id=1m7RBQAAQBAJ&pgis=1. Accessed December 18, 2015
Manach C., Brennan L, Drasgted L.O. Metabolomics to evaluate food intake and utilization in nutritional epidemiology. In: Metabolomics as a Tool in Nutritional Research, Woodhead publishing 2015. pp.167-196
Kesse-Guyot E, Castetbon K, Touvier M, Hercberg S, Galan P. Relative validity and reproducibility of a food frequency questionnaire designed for French adults. Ann Nutr Metab. 2010;57(3-4):153-62. doi: 10.1159/000321680. Epub 2010 Nov 16.
PubMed 21079389Vazquez-Manjarrez N, Weinert CH, Ulaszewska MM, Mack CI, Micheau P, Petera M, Durand S, Pujos-Guillot E, Egert B, Mattivi F, Bub A, Dragsted LO, Kulling SE, Manach C. Discovery and Validation of Banana Intake Biomarkers Using Untargeted Metabolomics in Human Intervention and Cross-sectional Studies. J Nutr. 2019 Oct 1;149(10):1701-1713. doi: 10.1093/jn/nxz125.
PubMed 31240312
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of New Biomarkers of Banana and Tomato Intake
- ClinicalTrials.gov ID
- NCT03581955
- Acronym / sponsor ID
- BioBanaTom / 2016-A00153-48
- Conditions
- Biomarkers, Food Intake
- Keywords
- biomarkers, diet, banana, tomato, urine, plasma, intake, exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Claudine MANACHUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 26 Mar 2016 (actual)
- Primary completion
- 19 May 2016 (actual)
- Study completion
- 16 Jun 2016 (actual)
- First posted
- 10 Jul 2018 (actual)
- 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The present project is a randomized, controlled, crossover study with 12 subjects. A cross-over design has been selected as each subject can serve as his/her own control thereby minimizing variations. The intervention order was randomized. The study design does not allow blinding as intervention is the ingestion of different foods.In this study, we assessed the metabolomic profiles of human biofluids after consumption of two different foods: banana (240g peeled fruit) and tomato (300g fresh fruit) in order to identify novel biomarkers for each food. As a control diet, a high energy high protein drink, Fresubin ® 2kcal fiber (Fresinius kabi) was used. The study comprised three dietary interventions of 4 days each and a wash-out period no shorter than 3 days.
| Arm | Type | Receives |
|---|---|---|
| Banana Cavendish | Experimental | Other: Banana Cavendish240g of fruit plus 150ml of Fresubin ® 2kcal fiber neutral flavor |
| Control drink | Experimental | Other: Fresubin ® 2kcal fiber neutral flavor250ml of Fresubin ® 2kcal fiber neutral flavor |
| Tomato | Experimental | Other: Tomato300g of tomato plus of Fresubin ® 2kcal fiber neutral flavor plus 12g of refined sunflower oil. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Banana CavendishAlso: Test Food240g of fruit plus 150ml of control drink (Fresubin ® 2kcal fiber neutral flavor) | Other | Banana Cavendish |
| TomatoAlso: Test Food300g of raw tomato ("coeur de boeuf") with refined sunflower oil (12g) and 150ml of control drink (Fresubin ® 2kcal fiber neutral flavor). | Other | Tomato |
| Fresubin ® 2kcal fiber neutral flavorAlso: Control250 ml Fresubin ® 2kcal fiber neutral flavor | Other | Control drink |
Primary outcome
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.
1 secondary outcome
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
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 16 Jul 2018.
- Background: PubMed 24390407Andersen MB, Kristensen M, Manach C, Pujos-Guillot E, Poulsen SK, Larsen TM, Astrup A, Dragsted L. Discovery and validation of urinary exposure markers for different plant foods by untargeted metabolomics. Anal Bioanal Chem. 2014 Mar;406(7):1829-44. doi: 10.1007/s00216-013-7498-5. Epub 2014 Jan 4.
- Background: PubMed 19764066Manach C, Hubert J, Llorach R, Scalbert A. The complex links between dietary phytochemicals and human health deciphered by metabolomics. Mol Nutr Food Res. 2009 Oct;53(10):1303-15. doi: 10.1002/mnfr.200800516.
- Background: PubMed 24760973Scalbert A, Brennan L, Manach C, Andres-Lacueva C, Dragsted LO, Draper J, Rappaport SM, van der Hooft JJ, Wishart DS. The food metabolome: a window over dietary exposure. Am J Clin Nutr. 2014 Jun;99(6):1286-308. doi: 10.3945/ajcn.113.076133. Epub 2014 Apr 23.
- Background: PubMed 12180131Re R, Bramley PM, Rice-Evans C. Effects of food processing on flavonoids and lycopene status in a Mediterranean tomato variety. Free Radic Res. 2002 Jul;36(7):803-10. doi: 10.1080/10715760290032584.
- Background: PubMed 10050865Giovannucci E. Tomatoes, tomato-based products, lycopene, and cancer: review of the epidemiologic literature. J Natl Cancer Inst. 1999 Feb 17;91(4):317-31. doi: 10.1093/jnci/91.4.317.
- Background: PubMed 25449450Pereira A, Maraschin M. Banana (Musa spp) from peel to pulp: ethnopharmacology, source of bioactive compounds and its relevance for human health. J Ethnopharmacol. 2015 Feb 3;160:149-63. doi: 10.1016/j.jep.2014.11.008. Epub 2014 Nov 13.
- Background: PubMed 23425595Pujos-Guillot E, Hubert J, Martin JF, Lyan B, Quintana M, Claude S, Chabanas B, Rothwell JA, Bennetau-Pelissero C, Scalbert A, Comte B, Hercberg S, Morand C, Galan P, Manach C. Mass spectrometry-based metabolomics for the discovery of biomarkers of fruit and vegetable intake: citrus fruit as a case study. J Proteome Res. 2013 Apr 5;12(4):1645-59. doi: 10.1021/pr300997c. Epub 2013 Mar 5.
- BackgroundPeralta I, Spooner DM. Genetic Improvement of Solanaceous Crops Volume 2: Tomato. CRC Press; 2006. https://books.google.com/books?hl=en&lr=&id=1m7RBQAAQBAJ&pgis=1. Accessed December 18, 2015
- BackgroundManach C., Brennan L, Drasgted L.O. Metabolomics to evaluate food intake and utilization in nutritional epidemiology. In: Metabolomics as a Tool in Nutritional Research, Woodhead publishing 2015. pp.167-196
- Background: PubMed 21079389Kesse-Guyot E, Castetbon K, Touvier M, Hercberg S, Galan P. Relative validity and reproducibility of a food frequency questionnaire designed for French adults. Ann Nutr Metab. 2010;57(3-4):153-62. doi: 10.1159/000321680. Epub 2010 Nov 16.
- Derived from this study: PubMed 31240312Vazquez-Manjarrez N, Weinert CH, Ulaszewska MM, Mack CI, Micheau P, Petera M, Durand S, Pujos-Guillot E, Egert B, Mattivi F, Bub A, Dragsted LO, Kulling SE, Manach C. Discovery and Validation of Banana Intake Biomarkers Using Untargeted Metabolomics in Human Intervention and Cross-sectional Studies. J Nutr. 2019 Oct 1;149(10):1701-1713. doi: 10.1093/jn/nxz125.
- Individual participant dataSharing planned: No
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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.
Claudine Manach, Researcher principal investigator
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Banana Cavendish, Tomato and Fresubin ® 2kcal fiber neutral flavor in people with Biomarkers and Food Intake, run by Claudine MANACH at 1 site in France.
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 4 inclusion and 12 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 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
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). 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 NCT03581955, which also lists 11 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 16 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.