Human Urinary Biomarker for Orange Juice Consumption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102062
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : November 7, 2016
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

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

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.

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

Arm Intervention/treatment
Experimental: Orange Juice
1 glass (=200mL) of orange juice
Dietary Supplement: orange juice

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01102062

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Imperial College London Identifier: NCT01102062     History of Changes
Other Study ID Numbers: 557-ICL-649
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: April 2009