Status:
COMPLETED
Gut Microbiota and Proteins Intake
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Gut microbiota are involved in the regulation of mammalian metabolic pathways through host-microbiota metabolic, signaling, and immune-inflammatory interactions that physiologically connect the gut, l...
Eligibility Criteria
Inclusion
- Caucasian
- Regular bowl movement (at least once every 1-2 days)
- Between 18 and 55 years old
- BMI between 18.5 and 27 kg/m2 (inclusive)
- Willing and able to sign written informed consent prior to trial entry
Exclusion
- Clinically relevant digestive, renal or metabolic disease, as determined by the medical (screening) visit and a standard blood chemistry analysis (glucose, total cholesterol, LDL, HDL, triglycerides, Aspartate aminotransferase (ASAT), Alanine aminotransferase (ALAT), gamma glutamyl transferase (Gamma-GT), C reactive protein (CRP), creatinine)
- Undergoing regular medical treatment, pain-killers accepted, based on the medical questionnaire
- Special diets: vegetarian, high protein or weight loss program (anamnesis)
- Pregnancy (anamnesis)
- Food allergy
- Participation in a cholesterol management program with functional foods like food supplement enriched in omega-3 fatty acids, dairy products enriched with phytosterols (margarines, yoghurts), evaluated during the medical visit
- Practicing more than 5 moderated physical activity per week
- Smoker (anamnesis)
- Have a high alcohol consumption (more than 2 drinks/day) (anamnesis)
- Consumption of illicit drugs, (anamnesis)
- Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
- Subject who cannot be expected to comply with the study procedures, including consuming the test products.
- Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02223585
Start Date
October 1 2014
End Date
March 1 2015
Last Update
April 20 2015
Active Locations (1)
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1
Metabolic Unit, Clinical Development Unit, Nestec
Lausanne, Switzerland, 1000