We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Food-related Differences in Human Metabolite Profiles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01102049
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Healthy 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  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Food-related Differences in Human Metabolite Profiles
Study Start Date : June 2009
Primary Completion Date : December 2009
Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: self-administered food intake
self-administered food intake according to dietary protocol
Dietary Supplement: fish, beef, fruit



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102049


Locations
United Kingdom
Imperial College London
London, United Kingdom, SW7 2AZ
Sponsors and Collaborators
Imperial College London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01102049     History of Changes
Other Study ID Numbers: 535-ICL-673
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: May 2009