Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393114
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-02
Brief Title:
Impacts of Fermented Plant-based Products High in Protein on Gut Microbiota and Health
Sponsor:
University of Eastern Finland
Organization:
University of Eastern Finland
Study Overview
Official Title:
Impacts of Fermented Plant-based Products High in Protein and Fibre on Gut Microbiota and Health a Randomized Controlled Cross-over Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None