The Impact of Plant-Based Protein-rich Food Products With Varying Degree of Processing on the Human Gut Microbiome Composition and Human Metabolome

NCT05885750 | Unknown

• 1 other identifier: Newplant
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

It is observed that replacing meat with protein-rich plant-based food products are associated with lower mortality and obesity prevention. Sources of plant proteins typically undergo several processing and refinement procedures to improve the taste and digestibility of plant-based food products. These procedures alter the chemical composition, which can impact the nutritional quality of the processed food. It is not known what is the impact of processed products on human metabolism and intestinal microbiota. Therefore, the impact of a set of plant-based protein-rich food products with varying degree of processing on the composition and function of human gut microbiome and metabolism will be assessed in a clinical intervention

Conditions

Metabolism; Gut Microbiota; Inflammation

Outcome Measures

Primary Outcomes (5)

• Metabolomics

  The changes in metabolism evoked by the interventions

  one week between the start and end of each intervention

• Transcriptomics

  The changes in endogenous gene expression on RNA level

  one week between the start and end of each intervention

• Metagenomics

  The alterations in the composition of gut microbiota

  one week between the start and end of each intervention

• Inflammation status by inflammatory cytokines

  The changes in inflammatory cytokines

  one week between the start and end of each intervention

• Inflammation status by high-sensitive CRP

  The changes in high-sensitive CRP by clinical biochemistry analysis

  one week between the start and end of each intervention

Secondary Outcomes (3)

• Glucose homeostasis

  one week between the start and end of each intervention

• Lipid homeostasis

  one week between the start and end of each intervention

• Body weight

  five weeks (baseline and at the end of the complete study / after three interventions and 2 wash-outs)

Study Arms (3)

Diet 1

EXPERIMENTAL

Unprocessed or minimally processed plant-based protein-rich food products

Behavioral: Unprocessed

Diet 2

EXPERIMENTAL

Mildly processed plant-based protein-rich food products

Behavioral: Mildly processed

Diet 3

EXPERIMENTAL

Heavily refined plant-based protein-rich food products

Behavioral: Heavily refined

Interventions

Unprocessed BEHAVIORAL

Participants will consume unprocessed or minimally processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.

Diet 1

Mildly processed BEHAVIORAL

Participants will consume mildly processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.

Diet 2

Heavily refined BEHAVIORAL

Participants will consume heavily refined processed commercially available plant-based protein-rich foods as meat replacement in their normal diet for one week.

Diet 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to participate
• years olf
• BMI 18.5-27 kg/m2

You may not qualify if:

• Chronic disease with continuous medication
• Antibiotic use in the past 6 months
• Active smoker
• Gluten-free or vegan diet
• Pregnancy, lactation
• Abnormal thyroid, liver, or kidney function
• Low hemoglobin

Sponsors & Collaborators

• University of Turku: lead

Study Sites (1)

Food Sciences Unit, Department of Life Technologies, Faculty of Technology, University of Turku

Turku, Finland

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Airway Resistance

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Kati Hanhineva, PhD

  University of Turku

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veera Houttu, PhD

CONTACT

+358504627287; veera.houttu@utu.fi

Kaisa Linderborg, PhD

CONTACT

+358294502472; kaisa.linderborg@utu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Crossover trial with two one-week wash-out periods in-between three interventions

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 2, 2023
• Study Start: April 5, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2024
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

FI (1)