Impacts of Fermented Pea- and Legume-based Product on Gut Microbiota and Health

NCT06743828 | Active Not Recruiting

• 1 other identifier: 159/2024 HealthFerm
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effects of consuming fermented pea- and legume-based product on gut and overall human health. It is a randomized, single-blinded, controlled, cross-over trial with a dietary intervention. A total of 100 participants will be enrolled in this study and they will eat both fermented and unfermented pea- and legume-based products for three weeks. Participants will eat their habitual diet between the dietary intervention periods (wash-out). During the study, participants' perceived health, inflammatory markers, glucose and lipid metabolism, tryptophan metabolites, gastrointestinal symptoms, and gut microbiota will be assessed.

Conditions

Metabolic Syndrome

Keywords

Fermentation; Plant Proteins, Dietary; Inflammation Mediators; Gastrointestinal Microbiome; Tryptophan; Cardiometabolic Health

Outcome Measures

Primary Outcomes (3)

• P-hs-CRP (mg/l)

  Weeks 3, 6, 9, and 12

• IL-22

  Weeks 3, 6, 9, and 12

• LBP (μg/ml)

  Weeks 3, 6, 9, and 12

Secondary Outcomes (9)

• Changes in the composition gut microbiota

  Weeks 3, 6, and 12

• Short-chain fatty acids assessed from plasma samples

  Weeks 3, 6, 9, and 12

• Glucose metabolism

  Weeks 3, 6, 9, and 12

• fP-Insu (mU/l)

  Weeks 3, 6, 9, and 12

• Lipid metabolism

  Weeks 3, 6, 9, and 12

Other Outcomes (2)

• Attitudes and values

  Weeks 3 and 12

• Opinions about the study products

  Weeks 6 and 12

Study Arms (3)

Fermented product

EXPERIMENTAL

Participants consume a fermented pea- and legume-based product daily for three weeks within their diet.

Other: Fermented meat alternative

Unfermented product

ACTIVE COMPARATOR

Participants consume an unfermented pea- and legume-based product daily for three weeks within their diet.

Other: Unfermented meat alternative

Habitual diet

NO INTERVENTION

Participants consume their habitual diet without any intervention products.

Interventions

Fermented meat alternative OTHER

Participants incorporate a novel fermented product into their habitual diet for three weeks. The product replaces the main protein source of the meal(s). Participants will receive dietary guidance on how to follow the intervention diet, as well as potential supplement recommendations provided by the authorized nutritionist.

Fermented product

Unfermented meat alternative OTHER

Participants incorporate an unfermented product into their habitual diet for three weeks. The product replaces the main protein source of the meal(s). Participants will receive dietary guidance on how to follow the intervention diet, as well as potential supplement recommendations provided by the authorized nutritionist.

Unfermented product

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Waist circumference \>90 cm (women) or \>100 cm (men) OR BMI 27-35 kg/m2
• One of the following:
• raised blood pressure (systolic ≥ 130 mmHg and/or diastolic 85 mmHg)
• raised fasting plasma glucose (≥ 5.6 mmol/l)
• raised triglycerides (≥ 1.7 mmol/l)
• raised total cholesterol (≥ 5 mmol/l)
• raised LDL (≥ 3 mmol/l)
• reduced HDL (women \< 1.3 mmol/l, men 1.0 mmol/l)
• Consumption of at least one meal where the main protein source is meat, fish, or meat alternative on most days
• Willingness to follow intervention diets for the whole study

You may not qualify if:

• Diagnosed chronic diseases and conditions which could hamper the adherence to the dietary intervention protocol, e.g., type 1 or 2 diabetes, chronic liver, thyroid, kidney, or gastrointestinal diseases
• Pregnancy and lactation
• Gluten-free or vegan diet
• Recent use of antibiotics (within 3 months)
• Gastrointestinal surgery (within 6 months)
• Alcohol abuse (AUDIT ≥ 15 p and measures of liver function)
• regular smoking or use of snus or nicotine bags

Sponsors & Collaborators

• University of Eastern Finland: lead
• University of Turku: collaborator
• Umeå University: collaborator
• KU Leuven: collaborator
• Flemish institute of biotechnology (VIB): collaborator
• ETH Zurich: collaborator

Study Sites (1)

Institute of Public Health and Clinical Nutrition, University of Eastern Finland

Kuopio, 70110, Finland

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marjukka Kolehmainen

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: January 14, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

FI (1)