An interventional study of Animal-based protein diet and Vegan-based protein diet in Healthy, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Switzerland. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-20.
Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Basic science
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.
Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Animal-based protein diet · Other: Vegan-based protein diet
Intra-individual plasma, stools, and urine omics to acute controlled feeding
Metabonomics on fasting blood, urine, and stools and microbiota composition by 1. defining individual baseline (3-Day baseline before start of diet challenges); 2. Examining effect of the dietary challenges (3-Day diet challenge vs. Baseline); 3. Examining global dietary effect (baseline after challenge 2 vs. baseline after challenge 1) and stability of dietary effect (3rd day of each diet challenge vs. baseline after the challenge)
Time frame: 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
Intra-individual plasma biochemistry response to acute controlled feeding
To evaluate effect of the dietary challenges (Day 3 vs Day1 of each diet challenge), the global dietary effect (baseline after challenge 2 vs. the baseline after challenge 1, Day 1 of diet challenge 1), stability of the dietary effect (3rd day of each diet challenge vs. baseline after the challenge)
Time frame: 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
Subject's omics adaptation phase to a controlled diet Subject's omics adaptation phase to a controlled diet
Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition
Time frame: 3-Day diet challenge 1 and 2
Comparison of intra-individual daytime plasma response amongst diets and free living restricted diets
Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition
Time frame: 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
Pairing of gut microbial metabolite to gut microbial composition to generate concept on gut functional system to be followed-up in future studies
Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition
Time frame: 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
Pairing dietary intake and preferences with subjects response in Omics endpoints
Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition and 3- Days dietary recall during diet challenges and food frequency questionnaire at baseline before start of diet challenges
Time frame: 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
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Société des Produits Nestlé (SPN)