Gut Microbiota and Proteins Intake

Nestlé

Status: Completed

Conditions: Healthy

Treatments: Other: Animal-based protein diet; Other: Vegan-based protein diet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02223585

13.28.MET

Details and patient eligibility

About

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, liver, brain, and other organs. Correlation of these metabotypes with gut microbial profiles facilitates deciphering inherent host-microbe relationships.

Microbiome sequencing have generated novel insights into the role of gut microbial composition in health and disease, but are limited in addressing the microbial contribution to host metabolism and the gut microbial dysbiosis in disease.

This is an exploratory trial, aiming to examine how gut microbial conditions determine response to dietary challenge by measuring urine, plasma and stool metabolites resulting from metabolism of protein, polyamines and bile acids in combination with stool bacterial composition. The focus of this trial is to evaluate impact of protein based food challenges, based on cross-over design of two diet challenges of animal and vegan protein sources.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

40 participants in 1 patient group

Cross-over single arm

Experimental group

Treatment:

Other: Vegan-based protein diet

Other: Animal-based protein diet