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| Name | Class |
|---|---|
| University of Turku | OTHER |
| Umeå University | OTHER |
| ETH Zurich | OTHER |
| KU Leuven |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermented product | Experimental | Participants will consume a fermented oat-based product daily for three weeks within their diet. |
|
| Unfermented product | Active Comparator | Participants will consume an unfermented oat-based product daily for three weeks within their diet. |
|
| Habitual diet | No Intervention | Participants consume their habitual diet without any intervention products. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented oat-based product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory marker 1 | P-hs-CRP (mg/l) | Weeks 3, 6, 9, and 12 |
| Inflammatory marker 2 | IL-22 | Weeks 3, 6, 9, and 12 |
| Inflammatory marker 3 | LBP (μg/ml) | Weeks 3, 6, 9, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the composition gut microbiota | Composition of gut microbiota will be analysed from faecal samples | Weeks 3, 6, and 12 |
| Glucose metabolism | fP-Gluk and B-HbA1C (mmol/l) |
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Inclusion Criteria:
Waist circumference >90 cm (women) or >100 cm (men) OR BMI 26-38 kg/m2
One of the following:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Marjukka Kolehmainen | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Eastern Finland | Kuopio | 70210 | Finland |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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During the run-in phase, participants consume their habitual diet. Subsequently, participants are randomized to incorporate one of the study products into their habitual diet for three weeks. The amount of the products to be consumed is 4-6 dl/day, with the precise amount being determined based on the participants' energy requirements. After the three-week diet period, participants will return to their habitual diet, followed by another three-week period during which they will consume the alternate intervention product. The overall duration of the study will be 12 weeks for each participant.
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| Unfermented oat-based product | 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. |
|
| Weeks 3, 6, 9, and 12 |
| Insulin response | fP-Insu (mU/l) | Weeks 3, 6, 9, and 12 |
| Lipid metabolism | fP-Kol, fP-Kol-HDL, fP-Kol-LDL, fP-Trigly, and fP-FFA (mmol/l) | Weeks 3, 6, 9, and 12 |
| Tryptophan metabolism | Tryptophan metabolites will be analysed with non-targeted metabolomics. | Weeks 3, 6, 9, and 12 |
| Self-reported overall health | Short Form-36 Health Survey (SF-36). Different sections are rated from 0 to 100 points, where higher scores mean better perceived health. | Weeks 3, 6, 9, and 12 |
| Self-reported mental health | General Health Questionnaire-12 (GHQ-12). The questionnaire is rated from 0 to 12 points, where higher score means greater psychological distress. | Weeks 3, 6, 9, and 12 |
| Self-reported gut health | Gastrointestinal Symptoms Rating Scale (GSRS) | Weeks 3, 6, 9, and 12 |
| Attitudes and values | Unvalidated questionnaire | Weeks 0 and 12 |
| Opinions about the study products | Unvalidated questionnaire | Weeks 6 and 12 |
| D009750 |
| Nutritional and Metabolic Diseases |