CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Banana Cavendish +2 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03581955
NCT03581955N/ACompleted

Identification of New Biomarkers of Banana and Tomato Intake

Claudine MANACH·interventional·Posted Jul 10, 2018·Updated Jul 16, 2018

In Brief

A clinical study evaluating Banana Cavendish, Tomato, and 1 other intervention for Biomarkers and Food Intake. Completed, enrolled 12 participants across 1 site.

Detailed 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 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 10, 2018
Enrollment StartMar 26, 2016
Primary CompletionMay 19, 2016
Study CompletionJun 16, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.0 years ago

Interventions

Banana Cavendishother

240g of fruit plus 150ml of control drink (Fresubin ® 2kcal fiber neutral flavor)

Tomatoother

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

250 ml Fresubin ® 2kcal fiber neutral flavor