Human Urinary Biomarker for Orange Juice Consumption
|First Received Date ICMJE||April 7, 2010|
|Last Updated Date||April 9, 2010|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To elucidate urinary biochemical markers for the consumption of orange juice.
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.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01102062 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To investigate the kinetics of elucidated biomarker excretion over time.
Excretion of proline betaine, as quantified from the 1H NMR spectrum of urine, will be plotted over time.
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Human Urinary Biomarker for Orange Juice Consumption|
|Official Title ICMJE||Human Urinary Biomarker for Orange Juice Consumption|
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.
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 ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Not Provided|
|Intervention ICMJE||Dietary Supplement: orange juice|
|Study Arm (s)||Not Provided|
|Publications *||Heinzmann SS, Brown IJ, Chan Q, Bictash M, Dumas ME, Kochhar S, Stamler J, Holmes E, Elliott P, Nicholson JK. Metabolic profiling strategy for discovery of nutritional biomarkers: proline betaine as a marker of citrus consumption. Am J Clin Nutr. 2010 Aug;92(2):436-43. Epub 2010 Jun 23.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 45 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United Kingdom|
|NCT Number ICMJE||NCT01102062|
|Other Study ID Numbers ICMJE||557-ICL-649|
|Has Data Monitoring Committee||No|
|Responsible Party||Prof. Nigel Gooderham, Imperial College London|
|Study Sponsor ICMJE||Imperial College London|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||Imperial College London|
|Verification Date||April 2010|
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