Clinical trial NCT05611138: Dietary Proteins: Metagenomic and Metabolomics Approaches for Human Biomarkers Identification
Official title: Växtbaserade Proteiners påverkan på tarmhälsa Hos människa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy male and female adult subjects (n=87) will be recruited to take part in a double-blinded, randomized, 3-arms parallel trial. Subjects that are eligible to take part in the study will be blinded and randomly allocated to consume an isolated plant protein (arm 1) or isolated animal protein (arm 2) or plant-based source of protein (arm 3). The subjects eligible to take part in this study will consume the proteins for 4 weeks, before the intervention they will have a baseline of two weeks, and after the intervention, they will have more two visits. Faecal and blood samples will be used to answer the main outcome of gut-related metabolites and microbiota profile. Blood and urine samples will be used 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.
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims to create a methodological framework, including the discovery and validation of novel biomarker panels to decipher the impact of plant-based protein intake on health biomarkers. Moreover, the possibility of predicting biomarkers production will be tested by a colonic in vitro fermentation study using study participants' faecal samples.

Detailed description: This study consists of a double-blind, randomised, 3-arm parallel trial, consisting of 2-wk baseline measurements, 4-wk intervention period (with weekly sample collection), and 2-wk after-intervention follow-up, with healthy subjects in each arm consuming different protein sources (from plant- or animal-based sources). Subjects that are eligible to take part in this study will be blinded and randomly allocated to consume an isolated pea protein (arm 1), animal protein (arm 2) or more complex protein pea protein powder (arm 3). The isolated plant and animal protein will be used to evaluate the specific effects of the proteins from the different sources. The more complex protein pea protein powder will be used as a more complex food matrix, containing other food components than protein, to assess how other pea components may impact the specific protein effects. Regardless of the differences in their structure, all supplement powders will be adjusted to provide the same amount of protein. The protein calculation will be done exclusively for each participant, based on their body weight (kg). They will consume up to 2 g of protein per body weight per day. Subjects will be asked to maintain their usual diet and their food intake will be accompanied during the intervention.

Participants' compliance will be followed by their food diaries and by clinical markers for protein intake and will collect blood, faeces and 24 h urine samples. A subset of the participants (max. 15 per arm) for visits 2 and 6 will be invited to participate in a postprandial challenge. After the fastening blood sample collection, they will receive the daily protein portion as breakfast. For those, 9 blood sample time points will be taken, being at 0, 15, 30, 60, 90, 120, 150, 180, and 480 min. After the 180 min measurement, they will receive a standard meal as lunch (e.g., pasta with tomato sauce).

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

Primary outcomes:
measure: Changes in the faecal metabolites using targeted and untargeted metabolomics during the intervention
timeFrame: 8 weeks
measure: Changes in the plasma metabolites using targete and untargeted metabolomics during the intervention
timeFrame: 4 weeks
measure: Profile/composition of the gut microbiota during the intervention
timeFrame: 8 weeks
measure: Routinely analysed markers for protein intake/compliance during the intervention - urine
timeFrame: 4 weeks
measure: Routinely analysed markers for protein intake/compliance during the intervention - blood
timeFrame: 4 weeks
measure: Changes in the plasma metabolites using targeted and untargeted metabolomics during the dietary challenge
timeFrame: 4 weeks
measure: Colonic in vitro fermentation
timeFrame: 4 weeks
Secondary outcomes:
measure: Food intake using food diaries
timeFrame: 8 weeks
measure: Assessment of the Gastrointestinal Symptom rating scale (GSRS) during the study
timeFrame: 8 weeks
measure: Assessment of the bowel movement using the Bristol scale diary
timeFrame: 8 weeks
measure: Assessment of physical activity level
timeFrame: 8 weeks
measure: Assessment of height
timeFrame: 4 weeks
measure: Assessment of body weight during the study
timeFrame: 4 weeks
measure: Assessment of body composition
timeFrame: 4 weeks
measure: Concentrations of faecal calprotectin
timeFrame: 4 weeks
measure: Fasting blood glucose level
timeFrame: 4 weeks
measure: Fasting blood insulin level
timeFrame: 4 weeks
measure: Fasting blood C-reactive protein level
timeFrame: 4 weeks
measure: Fasting blood cholesterol (total, LDL, and HDL) level
timeFrame: 4 weeks
measure: Fasting blood triglycerides level
timeFrame: 4 weeks
measure: Concentration of glucose - dietary challenge
timeFrame: 4 weeks
measure: Concentration of insulin - dietary challenge
timeFrame: 4 weeks
measure: Profile/composition of the gut microbiota after the intervention
timeFrame: 2 weeks
measure: Changes in the faecal metabolites using targeted and untargeted metabolomics after the intervention
timeFrame: 2 weeks
measure: Breath test
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Campus USÖ, Örebro University
Study officials:
affiliation: Örebro University, Sweden
name: Robert Brummer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: