Human Urinary Biomarker for Orange Juice Consumption

This study has been completed.
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01102062
First received: April 7, 2010
Last updated: April 9, 2010
Last verified: April 2010
  Purpose

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 Intervention
Healthy
Dietary Supplement: orange juice

Study Type: Interventional
Official Title: Human Urinary Biomarker for Orange Juice Consumption

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy individuals
  • male/female
  • aged 18-45 years
  • non-smoker
  • BMI 18-25 kg/m2

Exclusion Criteria:

  • regular drug intake
  • regular food supplements intake
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01102062

Locations
United Kingdom
Imperial College London
London, United Kingdom, SW7 2AZ
Sponsors and Collaborators
Imperial College London
  More Information

No publications provided by Imperial College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Nigel Gooderham, Imperial College London
ClinicalTrials.gov Identifier: NCT01102062     History of Changes
Other Study ID Numbers: 557-ICL-649
Study First Received: April 7, 2010
Last Updated: April 9, 2010
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on October 23, 2014