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

Sponsor
University of Turku (Other)
Overall Status
Recruiting
CT.gov ID
NCT05885750
Collaborator
(none)
38
1
3
20.9
1.8

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Unprocessed
  • Behavioral: Mildly processed
  • Behavioral: Heavily refined
N/A

Detailed Description

Plant-based diets are known to have beneficial effects on both the environment and human health. Replacing animal protein with plant protein reduces overall mortality risk, and replacing meat with legumes and other sources of plant protein can lower the risk of chronic diseases such as type 2 diabetes and cardiovascular disease. However, the benefits of plant protein products is not evident. In order to make plant protein products more palatable and digestible, plant raw materials may go through several processing and refinement procedures. Typically, during these phases, carbohydrate fractions (e.g. dietary fiber) are removed from the plant material, which results in the loss of micronutrients as well as secondary plant metabolites with potentially health effects (e.g. polyphenolic compounds). Salt and various fats are added to some products, which can reduce the nutritional quality of the product. Subsequently, not all plant-based protein-rich foods are automatically healthy as there may be significant differences in the nutritional quality of the processed products, depending on the food processing utilized. Only little research information is available on the effects of processed plant protein products on human metabolism and intestinal microbiota. Therefore, this cross-over clinical intervention will be conducted with 38 healthy participants to investigate 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Crossover trial with two one-week wash-out periods in-between three interventionsCrossover trial with two one-week wash-out periods in-between three interventions
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Impact of Plant-Based Protein-rich Food Products With Varying Degree of Processing on the Human Gut Microbiome Composition and Human Metabolome
Actual Study Start Date :
Apr 5, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diet 1

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

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

Experimental: Diet 2

Mildly processed plant-based protein-rich food products

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

Experimental: Diet 3

Heavily refined plant-based protein-rich food products

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

Outcome Measures

Primary Outcome Measures

  1. Metabolomics [one week between the start and end of each intervention]

    The changes in metabolism evoked by the interventions

  2. Transcriptomics [one week between the start and end of each intervention]

    The changes in endogenous gene expression on RNA level

  3. Metagenomics [one week between the start and end of each intervention]

    The alterations in the composition of gut microbiota

  4. Inflammation status by inflammatory cytokines [one week between the start and end of each intervention]

    The changes in inflammatory cytokines

  5. Inflammation status by high-sensitive CRP [one week between the start and end of each intervention]

    The changes in high-sensitive CRP by clinical biochemistry analysis

Secondary Outcome Measures

  1. Glucose homeostasis [one week between the start and end of each intervention]

    Fasting plasma glucose and insulin concentrations by clinical biochemistry analyses

  2. Lipid homeostasis [one week between the start and end of each intervention]

    Cholesterol and triglyceride concentrations by clinical biochemistry analyses

  3. Body weight [five weeks (baseline and at the end of the complete study / after three interventions and 2 wash-outs)]

    Body weight in kilograms measured by standard weight scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Willingness to participate

  • 18-65-years olf

  • BMI 18.5-27 kg/m2

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Food Sciences Unit, Department of Life Technologies, Faculty of Technology, University of Turku Turku Finland

Sponsors and Collaborators

  • University of Turku

Investigators

  • Principal Investigator: Kati Hanhineva, PhD, University of Turku

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marko Kalliomäki, MD, Clinical Professor, University of Turku
ClinicalTrials.gov Identifier:
NCT05885750
Other Study ID Numbers:
  • Newplant
First Posted:
Jun 2, 2023
Last Update Posted:
Jun 7, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2023