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Completed

NCT Number: NCT06393114

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

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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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Eastern Finland

Kuopio, 70210, Finland

About this study

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:

  • 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.
  • study the effects of fermented and unfermented plant-based food consumption on the markers for gut permeability and inflammation.
  • study the difference in microbiota composition and diversity after consuming fermented and unfermented plant-based foods and its contribution to cardiometabolic outcomes.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Waist circumference >90 cm (women) or >100 cm (men) OR BMI 26-38 kg/m2
  • One of the following:
  • raised blood pressure (systolic ≥ 130 mmHg and/or diastolic 85 mmHg)
  • raised fasting plasma glucose (≥ 5.6 mmol/l)
  • raised triglycerides (≥ 1.7 mmol/l)
  • raised total cholesterol (≥ 5 mmol/l)
  • raised LDL (≥ 3 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)
  • regular smoking or use of snus

Treatment and study plan

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.

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.

Primary outcomes

  1. Inflammatory marker 1

    Time frame: Weeks 3, 6, 9, and 12

    P-hs-CRP (mg/l)

  2. Inflammatory marker 2

    Time frame: Weeks 3, 6, 9, and 12

    IL-22

  3. Inflammatory marker 3

    Time frame: Weeks 3, 6, 9, and 12

    LBP (μg/ml)

Secondary outcomes

  1. Changes in the composition gut microbiota

    Time frame: Weeks 3, 6, and 12

    Composition of gut microbiota will be analysed from faecal samples

  2. Glucose metabolism

    Time frame: Weeks 3, 6, 9, and 12

    fP-Gluk and B-HbA1C (mmol/l)

  3. Insulin response

    Time frame: Weeks 3, 6, 9, and 12

    fP-Insu (mU/l)

  4. Lipid metabolism

    Time frame: Weeks 3, 6, 9, and 12

    fP-Kol, fP-Kol-HDL, fP-Kol-LDL, fP-Trigly, and fP-FFA (mmol/l)

  5. Tryptophan metabolism

    Time frame: Weeks 3, 6, 9, and 12

    Tryptophan metabolites will be analysed with non-targeted metabolomics.

  6. Self-reported overall health

    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.

  7. Self-reported mental 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.

  8. Self-reported gut health

    Time frame: Weeks 3, 6, 9, and 12

    Gastrointestinal Symptoms Rating Scale (GSRS)

  9. Attitudes and values

    Time frame: Weeks 0 and 12

    Unvalidated questionnaire

  10. Opinions about the study products

    Time frame: Weeks 6 and 12

    Unvalidated questionnaire

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Collaborators

  • ETH Zurich
  • KU Leuven
  • Umeå University
  • University of Turku

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 1, 2024
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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