Dietary Protein Impact on Human Gut Health

NCT ID: NCT05367804

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-27
• Study Completion Date: 2022-06-01

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.

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).

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Isolated plant protein

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).

Group Type: EXPERIMENTAL

Isolated pea protein

Intervention Type: 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.

Interventions

Isolated pea protein

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 Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Jan Brummer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

Campus USÖ, Örebro University

Örebro, , Sweden

Countries

Sweden

Other Identifiers

PanProtein

Identifier Type: -

Identifier Source: org_study_id