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Completed

NCT Number: NCT01102049

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London

London, SW7 2AZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fish, beef, fruit

Dietary Supplement

Primary outcomes

  1. To elucidate urinary biochemical markers for the consumption of fish, beef, fruit salad and grape.

    Time frame: 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 outcomes

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

    Time frame: 12 months

    Potential biomarkers (see primary outcome) will be quantified by integrating the NMR resonance and plotted over time.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 12, 2010
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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