Gut Microbiota and Proteins Intake

April 17, 2015 updated by: Nestlé

Gut Microbial Response to Well-balanced Diet With Emphasis on Animal or Vegan Protein

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1000
        • Metabolic Unit, Clinical Development Unit, Nestec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cross-over single arm
Other: Animal-based protein diet
Other: Vegan-based protein diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-individual plasma, stools, and urine omics to acute controlled feeding
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
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject's omics adaptation phase to a controlled diet Subject's omics adaptation phase to a controlled diet
Time Frame: 3-Day diet challenge 1 and 2
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Maurice Beaumont, MD, PhD, PD Dr, Metabolic Unit, Clinical Development Unit, Nestec

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 21, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 22, 2014

Study Record Updates

Last Update Posted (Estimate)

April 20, 2015

Last Update Submitted That Met QC Criteria

April 17, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13.28.MET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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