Full body composition and of plasma and urine metabolites
OtherFull body composition in lean, fat and bone mass will be assessed from DXA scans.
Plasma and urine metabolites will be measured using metabolomics
NCT Number: NCT02372968
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.
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Notify MeThe 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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All subjects must comply with all the following inclusion criteria:
Exclusion criteria
Subjects representing one or more of the following criteria are excluded from participation in the study:
1 month prior to the beginning of the study
Full body composition in lean, fat and bone mass will be assessed from DXA scans.
Plasma and urine metabolites will be measured using metabolomics
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
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
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
Time frame: Change of food habits after a period of 2 months post baseline
Measure of food habits based on Food Frequency Questionnaires
Société des Produits Nestlé (SPN)
Industry
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