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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cross-over single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Animal-based protein diet | Other |
| ||
| Vegan-based protein diet |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3-Day diet challenge 1 and 2 |
| Comparison of intra-individual daytime plasma response amongst diets and free living restricted diets |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurice Beaumont, MD, PhD, PD Dr | Metabolic Unit, Clinical Development Unit, Nestec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Unit, Clinical Development Unit, Nestec | Lausanne | 1000 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30724465 | Derived | 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. |
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| Other |
|
Through analysis of metabonomics on fasting blood, daytime blood, urine, and stools and microbiota composition |
| 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 | 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 | 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 |