HealthyNCT02372968
Use of Metabonomics and Body Imaging for Metabolic Health Assessment
An observational study of Healthy, run by Société des Produits Nestlé (SPN).
Trial summary
The aim of this pilot study is to develop at Nestlé Research Center a database of metabolic profiles, body composition, food habits and physical activities on a large cohort of human volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Full body composition and of plasma and urine metabolites
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Oct 2010
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Studied population: 100-300 subjects, men and women selected out of Nestlé employees
Who may be able to join
- All subjects must comply with all the following inclusion criteria:
- Having respected dietary restrictions 2 days before the visit
- Having obtained his/her or his/her legal representative's informed consent
Who cannot join
- Subjects representing one or more of the following criteria are excluded from participation in the study:
- Pregnancy as per precaution principal to avoid risks linked to X-ray exposure
- Any pathology (infectious or other) having required an antibiotic therapy within
- 1 month prior to the beginning of the study
- Any therapy (contraception apart) within the 2 days before the visit day
- Subject who cannot be expected to comply with measures
- Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
About this study
The aim of this pilot study is to develop at Nestlé Research Center a database of metabolic profiles, body composition, food habits and physical activities on a large cohort of human volunteers. Analysis of collected data will serve to measure the variability of the data and to assess the potential of combining metabonomics with imaging techniques (iDXA) to monitor the metabolic and physiologic effects of foods.
Read the detailed description
The study will be carried out at the metabolic unit of the Nestlé Research Center (Lausanne). A large cohort of subjects will be recruited among Nestlé employees. Body composition will be determined by iDXA (Dual-energy X-ray absorptiometry) and basal metabolism will be measured by metabonomic analysis of urine and plasma samples.
Individual food habits and physical activities will be assessed by questionnaires.
The clinical protocol plans also the measurement of energy expenditure (EE) by indirect calorimetry on a subset of twenty subjects. These EE data will be used to validate iDXA outcomes for resting energy expenditure.
The volunteers can participate a second time to this study in the case they would like to control the evolution of their body composition and metabolism after a period of dietary regime or physical training. In such a case, a minimum period of two months between the visits is required.
After two days of dietary restrictions, the volunteers will come in the morning at the metabolic unit at fasting state, for urine and blood sampling. The metabolism of some foods can bias the metabonomic analyses. Therefore, the consumption of alcoholic beverages, fish meals, liquorice, grapefruit, power drinks and bars, spices, mineral supplements, soft drinks, chocolate, coffee and tea limited to 2 cups per day, are not allowed during two days preceding the visit. In addition, the intake of pain-killers or antiinflammatory drugs is forbidden during the two days before the sampling of urine and blood because their metabolism alters the metabolic profiles of blood and urine.
Antibiotics alter gut microflora, for which the activity represents an important contributor to the urinary metabolic profile. In order to preserve gut microflora-related metabolic information, we recommend a minimum period of one month between the end of any antibiotic therapy and the visit at the metabolic unit.
On the visit day, subjects will come fasting at the metabolic unit, where they will have to:
- Answer some medical questions during an interview with the doctor in charge of the study
- Fill in two questionnaires on food habits and physical activities. A dietician of the CHUV will visit you at NRC to ask you for some questions relative to your food habits. This is to validate the new questionnaire you filled in
- Give a sample of urine
- Undergo iDXA scan (2 consecutive measures will be run at each of the two visits, in order to assess the intra-individual variability of the results) and measure of the state of hydration by bioimpedance The analysis of plasma samples is recommended to complete the metabonomic analysis. However, the blood sampling will be freely decided by each participant. The protocol plans also to perform measurements of resting energy expenditure by indirect calorimetry on a subset of twenty subjects.
- Conditions
- Healthy
- Being tested
- Full body composition and of plasma and urine metabolites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full body composition and of plasma and urine metabolitesOther
Full body composition in lean, fat and bone mass will be assessed from DXA scans.
Plasma and urine metabolites will be measured using metabolomics
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean, fat, and bone mass (Measure of full body composition in lean, fat, and bone mass)
Measure of full body composition in lean, fat, and bone mass
Measured: change of body composition after a period of 2 months following baseline
Screening of metabolites in plasma in fasting condition
Measure of plasma metabolites by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry
Measured: Change of plasma metabolites after a period of 2 months post baseline
Screening of urine metabolites in fasting condition
Measure of urine metabolites by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry
Measured: Change of urine metabolites after a period of 2 months post baseline
Food habits (Measure of food habits based on Food Frequency Questionnaires)
Measure of food habits based on Food Frequency Questionnaires
Measured: Change of food habits after a period of 2 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionOct 2010
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 Société des Produits Nestlé (SPN)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Serge Rezzi, PhD, Study director, Nestlé Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372968
- Sponsor's protocol ID
- 08.03.MET
- Status last verified
- Feb 2015
- First submitted
- 4 Feb 2015
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Wei R, Ross AB, Su M, Wang J, Guiraud SP, Draper CF, Beaumont M, Jia W, Martin FP. Metabotypes Related to Meat and Vegetable Intake Reflect Microbial, Lipid and Amino Acid Metabolism in Healthy People. Mol Nutr Food Res. 2018 Nov;62(21):e1800583. doi: 10.1002/mnfr.201800583. Epub 2018 Aug 28.
PubMed 30098305
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Metabonomics and Body Imaging for Metabolic Health Assessment
- ClinicalTrials.gov ID
- NCT02372968
- Acronym / sponsor ID
- 08.03.MET
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Feb 2015 (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.
The aim of this pilot study is to develop at Nestlé Research Center a database of metabolic profiles, body composition, food habits and physical activities on a large cohort of human volunteers. Analysis of collected data will serve to measure the variability of the data and to assess the potential of combining metabonomics with imaging techniques (iDXA) to monitor the metabolic and physiologic effects of foods.
Detailed description
The study will be carried out at the metabolic unit of the Nestlé Research Center (Lausanne). A large cohort of subjects will be recruited among Nestlé employees. Body composition will be determined by iDXA (Dual-energy X-ray absorptiometry) and basal metabolism will be measured by metabonomic analysis of urine and plasma samples.
Individual food habits and physical activities will be assessed by questionnaires.
The clinical protocol plans also the measurement of energy expenditure (EE) by indirect calorimetry on a subset of twenty subjects. These EE data will be used to validate iDXA outcomes for resting energy expenditure.
The volunteers can participate a second time to this study in the case they would like to control the evolution of their body composition and metabolism after a period of dietary regime or physical training. In such a case, a minimum period of two months between the visits is required.
After two days of dietary restrictions, the volunteers will come in the morning at the metabolic unit at fasting state, for urine and blood sampling. The metabolism of some foods can bias the metabonomic analyses. Therefore, the consumption of alcoholic beverages, fish meals, liquorice, grapefruit, power drinks and bars, spices, mineral supplements, soft drinks, chocolate, coffee and tea limited to 2 cups per day, are not allowed during two days preceding the visit. In addition, the intake of pain-killers or antiinflammatory drugs is forbidden during the two days before the sampling of urine and blood because their metabolism alters the metabolic profiles of blood and urine.
Antibiotics alter gut microflora, for which the activity represents an important contributor to the urinary metabolic profile. In order to preserve gut microflora-related metabolic information, we recommend a minimum period of one month between the end of any antibiotic therapy and the visit at the metabolic unit.
On the visit day, subjects will come fasting at the metabolic unit, where they will have to:
- Answer some medical questions during an interview with the doctor in charge of the study
- Fill in two questionnaires on food habits and physical activities. A dietician of the CHUV will visit you at NRC to ask you for some questions relative to your food habits. This is to validate the new questionnaire you filled in
- Give a sample of urine
- Undergo iDXA scan (2 consecutive measures will be run at each of the two visits, in order to assess the intra-individual variability of the results) and measure of the state of hydration by bioimpedance The analysis of plasma samples is recommended to complete the metabonomic analysis. However, the blood sampling will be freely decided by each participant. The protocol plans also to perform measurements of resting energy expenditure by indirect calorimetry on a subset of twenty subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Studied population: 100-300 subjects, men and women selected out of Nestlé employees
Key inclusion criteria (3 listed)
- Having respected dietary restrictions 2 days before the visit
- Having obtained his/her or his/her legal representative's informed consent
Key exclusion criteria (7 listed)
- Subjects representing one or more of the following criteria are excluded from participation in the study:
- Pregnancy as per precaution principal to avoid risks linked to X-ray exposure
- Any pathology (infectious or other) having required an antibiotic therapy within
- 1 month prior to the beginning of the study
- Any therapy (contraception apart) within the 2 days before the visit day
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 |
|---|---|---|
| Full body composition and of plasma and urine metabolitesFull body composition in lean, fat and bone mass will be assessed from DXA scans. Plasma and urine metabolites will be measured using metabolomics | Other | – |
Primary outcome
Lean, fat, and bone mass (Measure of full body composition in lean, fat, and bone mass)
Time frame: change of body composition after a period of 2 months following baseline
Measure of full body composition in lean, fat, and bone mass
Screening of metabolites in plasma in fasting condition
Time frame: Change of plasma metabolites after a period of 2 months post baseline
Measure of plasma metabolites by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry
Screening of urine metabolites in fasting condition
Time frame: Change of urine metabolites after a period of 2 months post baseline
Measure of urine metabolites by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry
Food habits (Measure of food habits based on Food Frequency Questionnaires)
Time frame: Change of food habits after a period of 2 months post baseline
Measure of food habits based on Food Frequency Questionnaires
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 14 May 2025.
- Derived from this study: PubMed 30098305Wei R, Ross AB, Su M, Wang J, Guiraud SP, Draper CF, Beaumont M, Jia W, Martin FP. Metabotypes Related to Meat and Vegetable Intake Reflect Microbial, Lipid and Amino Acid Metabolism in Healthy People. Mol Nutr Food Res. 2018 Nov;62(21):e1800583. doi: 10.1002/mnfr.201800583. Epub 2018 Aug 28.
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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.
Serge Rezzi, PhD study director
Nestlé Institute of Health Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Société des Produits Nestlé (SPN).
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 3 inclusion and 7 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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Lean, fat, and bone mass (Measure of full body composition in lean, fat, and bone mass) (time frame: change of body composition after a period of 2 months following baseline). The study lists 4 primary outcomes in all. 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 NCT02372968, 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 14 May 2025.