NCT06393114

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

Impacts of Fermented Plant-based Products High in Protein and Fibre on Gut Microbiota and Health: a Randomized, Controlled, Cross-over Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: University of Eastern Finland · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2024-01-22
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2024-05-01
• Last updated: 2025-01-09

Locations

1 site across 1 country: Finland