Use of Metabonomics and Body Imaging for Metabolic Health Assessment
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|ClinicalTrials.gov Identifier: NCT02372968|
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
|Condition or disease||Intervention/treatment|
|Healthy||Other: Full body composition and of plasma and urine metabolites|
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 Type :||Observational|
|Actual Enrollment :||225 participants|
|Official Title:||Use of Metabonomics and Body Imaging for Metabolic Health Assessment|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||October 2010|
- Other: Full body composition and of plasma and urine metabolites
Full body composition in lean, fat and bone mass will be assessed from DXA scans.
Plasma and urine metabolites will be measured using metabolomics
- 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
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): NCT02372968
|Study Director:||Serge Rezzi, PhD||Nestlé Institute of Health Sciences|