HealthyNCT01102049
Food-related Differences in Human Metabolite Profiles
A study testing fish, beef, fruit in people with Healthy, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- fish, beef, fruit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individuals
- male/female
- aged 18-45 years
- non-smoker
- BMI 18-25 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- fish, beef, fruit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish, beef, fruitDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| self-administered food intake | Experimental | self-administered food intake according to dietary protocol Receives: Dietary Supplement: fish, beef, fruit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102049
- Sponsor's protocol ID
- 535-ICL-673
- Status last verified
- Jun 2019
- First submitted
- 7 Apr 2010
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20573794
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food-related Differences in Human Metabolite Profiles
- ClinicalTrials.gov ID
- NCT01102049
- Acronym / sponsor ID
- 535-ICL-673
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2009 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| self-administered food intake | Experimental | Dietary Supplement: fish, beef, fruitself-administered food intake according to dietary protocol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy individuals
- male/female
- aged 18-45 years
- non-smoker
- BMI 18-25 kg/m2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fish, beef, fruit | Dietary supplement | self-administered food intake |
Primary outcome
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.
1 secondary outcome
To investigate the kinetics of elucidated biomarker excretion over time.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Derived from this study: PubMed 20573794Heinzmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fish, beef, fruit in people with Healthy, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To elucidate urinary biochemical markers for the consumption of fish, beef, fruit salad and grape. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01102049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.