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

NCT ID: NCT06743828

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2025-12-31

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.

Detailed Description

Plant-based protein sources, such as those derived from peas and legumes, are experiencing high demand due to their role in reducing reliance on animal products and promoting a more sustainable food system. Despite this, there is limited information available regarding the impact of components like fibre in plant-based foods on protein and other nutrients' metabolism. In addition, the evidence of the health effects of meat alternatives is still scarce.

Food fermentation emerges as a potential solution to enhance the absorption of plant-based protein and various nutrients in the small intestine. This is achieved by reducing antinutrients and facilitating the absorption process. Additionally, food fermentation has implications for the composition and metabolic activity of the gut microbiota, influencing metabolism, immune responses, intestinal function, and overall health. The metabolism of tryptophan in the gut, modulated by the gut microbiota and the production of various metabolites, may serve as a key link in these observed health effects.

The fermentation of plant-based foods potentially enhances their beneficial health effects, and investigating this contributes to an increased understanding of the gut-mediated health effects of foods and the mechanisms behind them. This study is part of a European research project HealthFerm.

Detailed objectives are to:

1. compare fermented and unfermented pea- and legume-based food products on blood lipid and glucose metabolism and gastrointestinal comfort as well as perceived and observed overall well-being.

2. study the effects of fermented and unfermented pea- and legume-based food consumption on gut permeability and inflammation markers.

3. study the difference in microbiota composition, diversity, and its contribution to cardiometabolic outcomes after consuming fermented and unfermented pea- and legume-based food products .

4. study the difference in microbiota-related metabolites, especially tryptophan metabolites, between fermented and unfermented pea- and legume-based food products.

A total of 100 participants will be enrolled in this randomized, single-blinded, controlled, cross-over trial, during which they will eat both fermented and unfermented pea- and legume-based products as part of their habitual diet. The study follows this sequence:

Weeks 1-3: Habitual diet Weeks 4-6: Intervention diet 1 Weeks 7-9: Habitual diet (wash-out) Weeks 10-12: Intervention diet 2

Fasting blood, urinary and faecal samples, as well as food diaries and questionnaires, are collected at the end of each study period to assess participants' diet, perceived health, gastrointestinal symptoms, inflammatory markers, glucose and lipid metabolism, tryptophan metabolites, and gut microbiota composition and their metabolites, such as short-chain fatty acids. In addition, participants' values and attitudes towards fermented foods are assessed. At the end of the study, participants will receive their laboratory results and dietary guidance for their habitual diet from a registered dietitian.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Fermented product

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

Group Type: EXPERIMENTAL

Fermented meat alternative

Intervention Type: 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.

Unfermented product

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

Group Type: ACTIVE_COMPARATOR

Unfermented meat alternative

Intervention Type: 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.

Habitual diet

Participants consume their habitual diet without any intervention products.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fermented meat alternative

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.

Intervention Type: OTHER

Unfermented meat alternative

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turku

OTHER

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: collaborator

Flemish institute of biotechnology (VIB)

OTHER

Sponsor Role: collaborator

ETH Zurich

OTHER

Sponsor Role: collaborator

University of Eastern Finland

OTHER

Sponsor Role: lead

Responsible Party

Marjukka Kolehmainen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marjukka Kolehmainen

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Locations

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

Kuopio, , Finland

Countries

Finland

Other Identifiers

159/2024 HealthFerm

Identifier Type: -

Identifier Source: org_study_id