Impacts of Fermented Oat-based Product on Gut Microbiota and Health

NCT ID: NCT06393114

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-22
• Study Completion Date: 2024-12-18

Brief Summary

This study aims to investigate the effects of consuming fermented oat-based products on gut and overall human health. It is a randomized, 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 oat-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 oats, 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.

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 effects.

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

Detailed objectives are to:

1. compare fermented and unfermented plant-based food products to 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 plant-based food consumption on the markers for gut permeability and inflammation.

3. study the difference in microbiota composition and diversity after consuming fermented and unfermented plant-based foods and its contribution to cardiometabolic outcomes.

4. study the difference in microbiota-related metabolites, especially tryptophan metabolites between fermented and unfermented plant-based foods.

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

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

Blood, urinary and faecal samples, as well as food diaries and questionnaires, are collected at the end of each study period to assess participants' perceived health, inflammatory markers, glucose and lipid metabolism, tryptophan metabolites, gastrointestinal symptoms, and gut microbiota. 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: NONE

Study Groups

Fermented product

Participants will consume a fermented oat-based product daily for three weeks within their diet.

Group Type: EXPERIMENTAL

Fermented oat-based product

Intervention Type: OTHER

Participants will incorporate a novel fermented product into their habitual diet for three weeks. In addition, the consumption of dairy and plant-based dairy alternatives is restricted. Cereal product consumption, specifically bread and porridge, is slightly restricted to prevent gastrointestinal symptoms caused by the increased intake of dietary fibre. 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 will consume an unfermented oat-based product daily for three weeks within their diet.

Group Type: ACTIVE_COMPARATOR

Unfermented oat-based product

Intervention Type: OTHER

Participants will incorporate a novel unfermented product into their habitual diet for three weeks. Dietary adjustments and other guidance are consistent with those described during the fermented product intervention.

Habitual diet

Participants consume their habitual diet without any intervention products.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fermented oat-based product

Participants will incorporate a novel fermented product into their habitual diet for three weeks. In addition, the consumption of dairy and plant-based dairy alternatives is restricted. Cereal product consumption, specifically bread and porridge, is slightly restricted to prevent gastrointestinal symptoms caused by the increased intake of dietary fibre. 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 oat-based product

Participants will incorporate a novel unfermented product into their habitual diet for three weeks. Dietary adjustments and other guidance are consistent with those described during the fermented product intervention.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Waist circumference >90 cm (women) or >100 cm (men) OR BMI 26-38 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)
• Use of cereal products and dairy products or their plant-based alternatives as a part of habitual diet
• 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., 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turku

OTHER

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: collaborator

ETH Zurich

OTHER

Sponsor Role: collaborator

KU Leuven

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

Professor

Locations

University of Eastern Finland

Kuopio, , Finland

Countries

Finland

Other Identifiers

HE 101060247

Identifier Type: -

Identifier Source: org_study_id