Food-related Differences in Human Metabolite Profiles
|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 fish, beef, fruit salad and grape.
1H NMR metabolic profiles will be acquired for all urine samples. These metabolic profiles contain a wealth of information about metabolites present in urine samples.
Multivariate mathematical model procedures, such as partial least squares discriminant analysis, will be employed to elucidate metabolic signatures associated to consumption of fish, beef, fruit salad and grape.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01102049 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To investigate the kinetics of elucidated biomarker excretion over time.
Potential biomarkers (see primary outcome) will be quantified by integrating the NMR resonance and 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||Food-related Differences in Human Metabolite Profiles|
|Official Title ICMJE||Food-related Differences in Human Metabolite Profiles|
Many population studies include food questionnaires (recording the normal food intake or the food intake of the study day). This is necessary, because diet is an important lifestyle factor, although food questionnaires are time-consuming and expensive. Moreover, mis-reporting is a very common problem. We therefore seek for a tool to validate food protocol.
The hypothesis is to find biochemical marker for animal protein, fruit intake and grape consumption in urinary metabolic profiles after specific food consumption. Furthermore we want to specify biomarkers for different animal protein sources, fish and beef.
Volunteers are asked to follow a diet plan over the whole course of the study. Every newly introduced food (in this study the dinner on days 2-5) will cause a change in biochemical marker excretion with urine. To monitor the kinetics of biomarker excretion it is necessary to collect urine several times a day; we will ask volunteers to collect the first morning urine, before lunch, before dinner and before going to bed. Urine sampling will start with the first morning urine on day 1 and end with first morning urine on day 7.
As test food, we propose a fruit salad (apples, grapes, orange and grapefruit) on day 2, fish on day 3, grapes on day 4, beef on day 5 and again fish for lunch on day 6.
From day 0 (run-in day) to day 6 the basic diet will always be bread and cheese for breakfast, coffee in the morning, a ham sandwich for lunch, and pasta and tomato sauce for dinner. As beverages only water will be allowed (although wine is permitted on day 4 if the subject wishes but this is not a protocol requirement). The test foods will be consumed in addition to that.
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 identify new food biomarkers.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Not Provided|
|Intervention ICMJE||Dietary Supplement: fish, beef, fruit|
|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||NCT01102049|
|Other Study ID Numbers ICMJE||535-ICL-673|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|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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