Gut Microbiota and Proteins Intake

NCT02223585 | Completed

• 1 other identifier: 13.28.MET
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Gut microbial; response; to protein-based; diet; challenges; population

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Subject's omics adaptation phase to a controlled diet Subject's omics adaptation phase to a controlled diet

  3-Day diet challenge 1 and 2

• Comparison of intra-individual daytime plasma response amongst diets and free living restricted diets

  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

  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

  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

Study Arms (1)

Cross-over single arm

EXPERIMENTAL

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

Interventions

Animal-based protein diet OTHER

Cross-over single arm

Vegan-based protein diet OTHER

Cross-over single arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Metabolic Unit, Clinical Development Unit, Nestec

Lausanne, 1000, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 30724465 DERIVED

Study Officials

• Maurice Beaumont, MD, PhD, PD Dr

  Metabolic Unit, Clinical Development Unit, Nestec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 20, 2015

Record last verified: 2015-04

Locations

CH (1)