Food-related Differences in Human Metabolite Profiles

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: fish, beef, fruit

Detailed Description

Volunteers are asked to follow a diet plan over the whole course of the study. Every newly introduced food (in this study the dinner on days 2-5) will cause a change in biochemical marker excretion with urine. To monitor the kinetics of biomarker excretion it is necessary to collect urine several times a day; we will ask volunteers to collect the first morning urine, before lunch, before dinner and before going to bed. Urine sampling will start with the first morning urine on day 1 and end with first morning urine on day 7.

As test food, we propose a fruit salad (apples, grapes, orange and grapefruit) on day 2, fish on day 3, grapes on day 4, beef on day 5 and again fish for lunch on day 6.

From day 0 (run-in day) to day 6 the basic diet will always be bread and cheese for breakfast, coffee in the morning, a ham sandwich for lunch, and pasta and tomato sauce for dinner. As beverages only water will be allowed (although wine is permitted on day 4 if the subject wishes but this is not a protocol requirement). The test foods will be consumed in addition to that.

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 identify new food biomarkers.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW7 2AZ
    • Imperial College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• antibiotics intake in the last 3 months
• not willing to eat one or more items of the foods listed in the diet plan

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: self-administered food intake; self-administered food intake according to dietary protocol	Dietary supplement: fish, beef, fruit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the kinetics of elucidated biomarker excretion over time.	Potential biomarkers (see primary outcome) will be quantified by integrating the NMR resonance and plotted over time.	12 months

Collaborators and Investigators

• Sponsor: Imperial College London

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: April 7, 2010
• First Submitted That Met QC Criteria: April 9, 2010
• First Posted (Estimate): April 12, 2010

Study Record Updates

• Last Update Posted (Actual): July 1, 2019
• Last Update Submitted That Met QC Criteria: June 28, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 535-ICL-673