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Completed

NCT Number: NCT01102062

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London

London, SW7 2AZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orange Juice

Dietary Supplement

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 12, 2010
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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