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OpenTrials
Completed

NCT Number: NCT02223585

Gut Microbiota and Proteins Intake

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metabolic Unit, Clinical Development Unit, Nestec

Lausanne, 1000, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Animal-based protein diet

Other

Vegan-based protein diet

Other

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

  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. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 22, 2014
Registry last updated
Apr 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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