Human Urinary Biomarker for Orange Juice Consumption
|ClinicalTrials.gov Identifier: NCT01102062|
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : November 7, 2016
Human urinary metabolic profiling showed to be very successful to elucidate biomarkers linked to geographic origin and specific food consumption patterns (Holmes and Loo et al.: Human metabolic phenotype diversity and its association with diet and blood pressure. Nature 2008:1-6). It was possible to identify urinary metabolites directly linked to animal vs. vegetable protein intake. This is very valuable for future population studies, where diet is an important lifestyle factor but food questionnaires are time-consuming and expensive. Moreover, miss-reporting is a very common problem.
Our hypothesis is to find the same biochemical marker for orange juice as we already found in a preceding nutritional studies where participants recorded orange consumption.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: orange juice||Not Applicable|
To elucidate the citrus fruit biomarker it needs to be ensured that all volunteers do not consume citrus fruits and foods potentially containing similar ingredients. Therefore it is necessary to ask volunteers to refrain from these foods by giving them dietary restrictions. Extensive literature research showed that some foods (such as grain legumes and brie cheese) may contain the same compound, but in much smaller amounts.
Days 1-3 will be on open diet but with dietary restrictions (no alcohol, cheese, fruits, ethnic foods such as Chinese and Indian food, grain legumes such as beans, lentils, peas and peanuts, and all kinds of sprouts (such as cress or alfalfa)). On day 2 a glass of orange juice (200ml) will be consumed in addition to the open diet. Urine collection will continue and stop on day 4 at 10 am.
During the study to minimise variation in biomarker excretion due to other beverages the participants beverage intake will be restricted to water and coffee.
All urine samples will then be analysed using high resolution NMR spectroscopy and mass spectrometry. Mathematical data analyses as well as the visual examinations of the NMR spectra will also be carried out to validate the presence of citrus fruit biomarkers.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Human Urinary Biomarker for Orange Juice Consumption|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Experimental: Orange Juice
1 glass (=200mL) of orange juice
|Dietary Supplement: orange juice|
- To elucidate urinary biochemical markers for the consumption of orange juice. [ Time Frame: 6 months ]1H NMR urinary metabolite spectra will be acquired. Proline betaine will be quantified by peak integration of the resonance at 3.11ppm in the NMR spectrum.
- To investigate the kinetics of elucidated biomarker excretion over time. [ Time Frame: 6 months ]Excretion of proline betaine, as quantified from the 1H NMR spectrum of urine, will be plotted over time.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102062
|Imperial College London|
|London, United Kingdom, SW7 2AZ|