University of Eastern Finland
Kuopio, 70210, Finland
NCT Number: NCT06393114
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.
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Notify Me30 year–65 year
All sexes
Interventional
Not applicable
Kuopio, 70210, Finland
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Weeks 3, 6, 9, and 12
P-hs-CRP (mg/l)
Time frame: Weeks 3, 6, 9, and 12
IL-22
Time frame: Weeks 3, 6, 9, and 12
LBP (μg/ml)
Time frame: Weeks 3, 6, and 12
Composition of gut microbiota will be analysed from faecal samples
Time frame: Weeks 3, 6, 9, and 12
fP-Gluk and B-HbA1C (mmol/l)
Time frame: Weeks 3, 6, 9, and 12
fP-Insu (mU/l)
Time frame: Weeks 3, 6, 9, and 12
fP-Kol, fP-Kol-HDL, fP-Kol-LDL, fP-Trigly, and fP-FFA (mmol/l)
Time frame: Weeks 3, 6, 9, and 12
Tryptophan metabolites will be analysed with non-targeted metabolomics.
Time frame: Weeks 3, 6, 9, and 12
Short Form-36 Health Survey (SF-36). Different sections are rated from 0 to 100 points, where higher scores mean better perceived health.
Time frame: Weeks 3, 6, 9, and 12
General Health Questionnaire-12 (GHQ-12). The questionnaire is rated from 0 to 12 points, where higher score means greater psychological distress.
Time frame: Weeks 3, 6, 9, and 12
Gastrointestinal Symptoms Rating Scale (GSRS)
Time frame: Weeks 0 and 12
Unvalidated questionnaire
Time frame: Weeks 6 and 12
Unvalidated questionnaire
University of Eastern Finland
Other
Impacts of Fermented Plant-based Products High in Protein and Fibre on Gut Microbiota and Health: a Randomized, Controlled, Cross-over Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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