Dietary Protein Impact on Human Gut Health
Condition: Healthy
Study type: Interventional

Summary: 
      The overall aim of this project is to evaluate the quantity of dietary protein that affects
      gut protein metabolization and if the baseline measurements are stable.
    

Detailed description: 
      Healthy male and female adult subjects (n=39) will be recruited to take part in an evaluation
      study to determine the amount of dietary protein intake which influences gut-protein-derived
      metabolites production. The subjects eligible to take part in this study will consume an
      isolated plant protein for 4 weeks, in each week the amount of protein supplementation will
      increase. The protein will be provided as a powder in opaque bags and participants will be
      instructed to dissolve the contained powder in liquids (as water) or on their food (e.g.,
      yogurt, oat porridge). The baseline will consist in 4 visits, which in all visits faecal
      samples will be collected by themselves at their house or at hospital, using materials
      provided by the study staff. In one baseline visits (visit 4) in addition to the faecal
      sample, urinary sample will be collected by themselves, and blood samples will be collected
      at the hospital. After that, subjects will have the dietary intervention for four weeks and
      more 4 visits. For the visits with blood collection (visits 4 to 8), subjects will come to
      the study centre after 10 hours overnight fast. Subjects will have anthropometry measurements
      taken in the visits 4, 5, 6, and 7 using a Tanita® full body composition. Subjects will
      respond to questionnaires about their physical activity (once a week), Gastrointestinal
      Symptom rating scale (GSRS - once a week) and track their intestinal habits using Bristol
      scale (every day). Subjects' diet will be assessed using a web-based 24-hour diet recall
      (interviewed so the participants learn how to use the tool regardless of where they are)
      followed by multiple day records (3 times week).
    

Intervention name(s): Isolated pea protein
Intervention type(s): Dietary Supplement
Intervention description(s): The subjects eligible to take part in this study will consume an isolated plant protein for 4 weeks (week 4 to 8), in each week the amount of protein supplementation will increase (0.25 to 1.0 g of protein per kg of body weight). The protein will be provided as a powder in opaque bags and participants will be instructed to dissolve the contained powder in liquids (as water) or on their food (e.g., yogurt, oat porridge). The baseline will consist of 4 visits (1 to 4) to see how stable are the baseline results.
Intervention model: Single Group Assignment
Intervention model description: Healthy male and female adult subjects (n=39) will be recruited to take part in an evaluation study to determine the amount of dietary protein intake which influences gut-protein-derived metabolites production. The study consists of 8 weeks with weekly visits and the subjects will consume an isolated plant-protein for 4 weeks (week 4 to 8), in each week the amount of protein supplementation will increase. Faecal samples will be used to answer the main outcome of gut metabolites and microbiota profile. And the blood and urine samples to measure health status and compliance (protein intake markers). Questionnaires will be used to access gastrointestinal symptoms and bowel movement, physical activity level and dietary intake.
Masking: None (Open Label)
Primary purpose: Basic Science