Food-related Differences in Human Metabolite Profiles

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: fish, beef, fruit

• Registration Number: NCT01102049
• Lead Sponsor: Imperial College London

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.

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 Timeline

• Study Start: 2009-06
• 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: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
self-administered food intake	fish, beef, fruit	self-administered food intake according to dietary protocol

Primary Outcome Measures

Name	Time	Method
To elucidate urinary biochemical markers for the consumption of fish, beef, fruit salad and grape.	12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom