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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06393114
Other study ID # HE 101060247
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 22, 2024
Est. completion date December 2024

Study information

Verified date April 2024
Source University of Eastern Finland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria: - Waist circumference >90 cm (women) or >100 cm (men) OR BMI 27-35 kg/m2 - One of the following: - raised blood pressure (= 130/85 mmHg) - raised fasting plasma glucose (= 5.6 mmol/l) or triglycerides (= 1.7 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)

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Finland University of Eastern Finland Kuopio

Sponsors (5)

Lead Sponsor Collaborator
University of Eastern Finland ETH Zurich, KU Leuven, Umeå University, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inflammatory marker 1 P-hs-CRP (mg/l) Weeks 3, 6, 9, and 12
Primary Inflammatory marker 2 IL-22 Weeks 3, 6, 9, and 12
Primary Inflammatory marker 3 LBP (µg/ml) Weeks 3, 6, 9, and 12
Secondary Changes in the composition gut microbiota Composition of gut microbiota will be analysed from faecal samples Weeks 3, 6, and 12
Secondary Glucose metabolism fP-Gluk and B-HbA1C (mmol/l) Weeks 3, 6, 9, and 12
Secondary Insulin response fP-Insu (mU/l) Weeks 3, 6, 9, and 12
Secondary Lipid metabolism fP-Kol, fP-Kol-HDL, fP-Kol-LDL, fP-Trigly, and fP-FFA (mmol/l) Weeks 3, 6, 9, and 12
Secondary Tryptophan metabolism Tryptophan metabolites will be analysed with non-targeted metabolomics. Weeks 3, 6, 9, and 12
Secondary 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
Secondary 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
Secondary Self-reported gut health Gastrointestinal Symptoms Rating Scale (GSRS) Weeks 3, 6, 9, and 12
Secondary Attitudes and values Unvalidated questionnaire Weeks 0 and 12
Secondary Opinions about the study products Unvalidated questionnaire Weeks 6 and 12
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