Dietary Protein Impact on Human Gut Health

NCT05367804 | Completed

• 1 other identifier: PanProtein
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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)

  5 weeks

Secondary Outcomes (16)

• Food intake using food diaries

  8 weeks

• Changes in the gut microbiota profile during the baseline period

  4 weeks

• Changes in the faecal metabolites during the baseline period

  4 weeks

• Profile/composition of the gut microbiota during the intervention

  5 weeks

• Assessment of the Gastrointestinal Symptom rating scale (GSRS) during the study

  8 weeks

Study Arms (1)

Isolated plant protein

EXPERIMENTAL

Visit 1 to 8 participants will collect faecal samples. Visits 4 to 8 in addition to the faecal sample, urinary samples (24 h urine collection) will be collected by themselves, and blood sample will be collected at the hospital. For the visits with blood collection (visits 4 to 8), subjects will come to the study centre after 10 hours of 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 a week).

Dietary Supplement: Isolated pea protein

Interventions

Isolated pea protein DIETARY_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.

Isolated plant protein

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

Campus USÖ, Örebro University

Örebro, 70362, Sweden

Location

Study Officials

• Robert Jan Brummer, MD, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: May 10, 2022
• Study Start: October 27, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

SE (1)