Gut Microbiota and Proteins Intake

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intestinal Microbiota: Immunity, Recovery and Metabolic Health

NCT06355089

Healthy

COMPLETED NA

the Role of Probiotic in Protein Metabolism

NCT06307821

Healthy

COMPLETED NA

Effect of Probiotic on the Gut Microbiota of Healthy Volunteers

NCT06103253

Healthy Adults

COMPLETED NA

Batch Fermentation and Microbiome Analysis

NCT06097130

Healthy

COMPLETED

Effect of The Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome

NCT06304480

Gut Microbiome

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cross-over single arm

Group Type EXPERIMENTAL

Animal-based protein diet

Intervention Type OTHER

Vegan-based protein diet

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Animal-based protein diet

Intervention Type OTHER

Vegan-based protein diet

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes