NCT01102062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
Last Updated

July 1, 2019

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

April 7, 2010

Last Update Submit

June 28, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • To investigate the kinetics of elucidated biomarker excretion over time.

    6 months

Study Arms (1)

Orange Juice

EXPERIMENTAL

1 glass (=200mL) of orange juice

Dietary Supplement: orange juice

Interventions

orange juiceDIETARY_SUPPLEMENT
Orange Juice

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • regular drug intake
  • regular food supplements intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, SW7 2AZ, United Kingdom

Location

Related Publications (1)

  • 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. doi: 10.3945/ajcn.2010.29672. Epub 2010 Jun 23.

    PMID: 20573794DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 12, 2010

Study Start

May 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 1, 2019

Record last verified: 2019-06

Locations

GB(1)