Human Urinary Biomarker for Orange Juice Consumption

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: orange juice

• Registration Number: NCT01102062
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-05
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-09
• Study First Posted: 2010-04-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Orange Juice	orange juice	1 glass (=200mL) of orange juice

Primary Outcome Measures

Name	Time	Method
To elucidate urinary biochemical markers for the consumption of orange juice.	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

Name	Time	Method
To investigate the kinetics of elucidated biomarker excretion over time.	6 months	Excretion of proline betaine, as quantified from the 1H NMR spectrum of urine, will be plotted over time.

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom