Food-related Differences in Human Metabolite Profiles
1 other identifier
interventional
7
1 country
1
Brief Summary
Many population studies include food questionnaires (recording the normal food intake or the food intake of the study day). This is necessary, because diet is an important lifestyle factor, although food questionnaires are time-consuming and expensive. Moreover, mis-reporting is a very common problem. We therefore seek for a tool to validate food protocol. The hypothesis is to find biochemical marker for animal protein, fruit intake and grape consumption in urinary metabolic profiles after specific food consumption. Furthermore we want to specify biomarkers for different animal protein sources, fish and beef.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 7, 2010
CompletedFirst Posted
Study publicly available on registry
April 12, 2010
CompletedJuly 1, 2019
June 1, 2019
6 months
April 7, 2010
June 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
To elucidate urinary biochemical markers for the consumption of fish, beef, fruit salad and grape.
1H NMR metabolic profiles will be acquired for all urine samples. These metabolic profiles contain a wealth of information about metabolites present in urine samples. Multivariate mathematical model procedures, such as partial least squares discriminant analysis, will be employed to elucidate metabolic signatures associated to consumption of fish, beef, fruit salad and grape.
12 months
Secondary Outcomes (1)
To investigate the kinetics of elucidated biomarker excretion over time.
12 months
Study Arms (1)
self-administered food intake
EXPERIMENTALself-administered food intake according to dietary protocol
Interventions
Eligibility Criteria
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
- antibiotics intake in the last 3 months
- not willing to eat one or more items of the foods listed in the diet plan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College London
London, SW7 2AZ, United Kingdom
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
June 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
July 1, 2019
Record last verified: 2019-06