Gut Microbiota and Proteins Intake

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223585
• Other study ID #: 13.28.MET
• Status: Completed
• Phase: N/A
• First received: August 21, 2014
• Last updated: April 17, 2015
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Animal-based protein diet

• Vegan-based protein diet

Locations

Country	Name	City	State
Switzerland	Metabolic Unit, Clinical Development Unit, Nestec	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	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	No
Secondary	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	No
Secondary	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	No