Dietary Protein Impact on Human Gut Health

Örebro University, Sweden32 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Isolated pea proteinDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-45 years * Body mass index (BMI) 18,5-30 kg/m2 * Weight stable within the previous 3 months * Maintenance of the usual physical activity habits during the study * Intake of fibre between 15 and 25 g per day (evaluated by 3 food diaries or 24-hours recalls) * Omnivores Exclusion Criteria: * Acute chronic disease, inflammatory or functional gastrointestinal diseases and any other disease or disorder that could affect the outcome of the study * Use of a medication that may interfere the study outcome * Eating disorder * High protein intake (more than 15% of energy or maximum 1,2 g of protein per kg of body weight per day; evaluated by 3 food diaries or 24-hours recalls) * Use of antibiotic medication during the last 3 months prior the first visit * Use of antibiotic medication very early in life (e.g., asthmatic children or ear inflammation) * Use of laxative or anti-diarrhoea medication within the past 3 months before the study * Regular consumption of probiotic or prebiotic product for the past 6 weeks before the study * Special diet that is considered to affect the study participation and/or study results, for example, high protein diets * More than 5 h of moderate-vigorous exercise per week * Pregnancy or breastfeeding * Intolerance to dietary supplements that will be used in the study * Smoking * Abuse of alcohol or drugs (according to AUDIT score)

Locations (1)

Campus USÖ, Örebro University

Örebro, Sweden

Outcomes

Primary Outcomes

Changes in the faecal metabolites using targeted and untargeted metabolomics

Difference in faecal metabolites depending on the protein supplementation amount. Targeted and untargeted metabolomics measurements will be used (e.g., short-chain fatty acids and branched chain fatty acids analyses, and polar and non polar metabolomics). Faecal samples will have their metabolites extracted and quantified by liquid chromatography coupled with high-resolution time-of-flight mass spectrometry (UHPLC-qToF-MS), and gas chromatography coupled with high-resolution mass spectroscopy (GC-Orbitrap). The level of metabolites will be compared throughout the whole study.

Time frame: 8 weeks

Routinely analysed markers for protein intake/compliance - urine

Difference in 24 h urine samples markers due to the protein supplementation (e.g., for 24 h urine: urea nitrogen from 24 h urine, creatinine, uric acid)

Time frame: 5 weeks

Routinely analysed markers for protein intake/compliance - blood

Difference in blood (serum) samples markers due to the protein supplementation (e.g., urea and creatinine)

Time frame: 5 weeks

Secondary Outcomes

Food intake using food diaries

Food diaries 3 times a week

Time frame: 8 weeks

Changes in the gut microbiota profile during the baseline period

Difference in the gut microbiota profile/composition during the baseline period will be assessed by 16s/NGS (next-generation sequencing). Alpha and Beta diversity will be measured and compared throughout these 4 weeks of baseline.

Time frame: 4 weeks

Changes in the faecal metabolites during the baseline period

Data from ClinicalTrials.gov

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