Clinical trial NCT02223585: Gut Microbiota and Proteins Intake
Official title: Gut Microbial Response to Well-balanced Diet With Emphasis on Animal or Vegan Protein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Gut microbial
response
to protein-based
diet
challenges
population
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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, 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Intra-individual plasma, stools, and urine omics to acute controlled feeding
timeFrame: 3-Day baseline, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout
measure: Intra-individual plasma biochemistry response to acute controlled feeding
timeFrame: Day 1 and 3 of diet challenge 1, 1-Day baseline after challenge 1 washout, Day 1 and 3 of diet challenge 2, 1-Day baseline after challenge 2 washout
Secondary outcomes:
measure: Subject's omics adaptation phase to a controlled diet Subject's omics adaptation phase to a controlled diet
timeFrame: 3-Day diet challenge 1 and 2
measure: Comparison of intra-individual daytime plasma response amongst diets and free living restricted diets
timeFrame: 3-Day baseline before start of diet challenges, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout
measure: Pairing of gut microbial metabolite to gut microbial composition to generate concept on gut functional system to be followed-up in future studies
timeFrame: 3-Day baseline before start of diet challenges, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout
measure: Pairing dietary intake and preferences with subjects response in Omics endpoints
timeFrame: 3-Day baseline before start of diet challenges, 3-Day diet challenge 1, 1-Day baseline after challenge 1 washout, 3-Day diet challenge 2, 1-Day baseline after challenge 2 washout
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Metabolic Unit, Clinical Development Unit, Nestec
Study officials:
affiliation: Metabolic Unit, Clinical Development Unit, Nestec
name: Maurice Beaumont, MD, PhD, PD Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Draper CF, Tini G, Vassallo I, Godin JP, Su M, Jia W, Beaumont M, Moco S, Martin FP. Vegan and Animal Meal Composition and Timing Influence Glucose and Lipid Related Postprandial Metabolic Profiles. Mol Nutr Food Res. 2019 Mar;63(5):e1800568. doi: 10.1002/mnfr.201800568. Epub 2019 Feb 21.