Healthy Clinical Trial - Dietary Proteins: Metagenomic & Metabolomics

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT05611138
Study type	Interventional
Source	Örebro University, Sweden
Contact
Status	Completed
Phase	N/A
Start date	September 15, 2022
Completion date	April 14, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Dietary Proteins: Metagenomic and Metabolomics Approaches for Human Biomarkers Identification

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms