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

NCT06393114 | Completed

• 1 other identifier: HE 101060247
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Fermentation; Plant Proteins, Dietary; Inflammation Mediators; Gastrointestinal Microbiome; Tryptophan

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (10)

• Changes in the composition gut microbiota

  Weeks 3, 6, and 12

• Glucose metabolism

  Weeks 3, 6, 9, and 12

• Insulin response

  Weeks 3, 6, 9, and 12

• Lipid metabolism

  Weeks 3, 6, 9, and 12

• Tryptophan metabolism

  Weeks 3, 6, 9, and 12

Study Arms (3)

Fermented product

EXPERIMENTAL

Participants will consume a fermented oat-based product daily for three weeks within their diet.

Other: Fermented oat-based product

Unfermented product

ACTIVE COMPARATOR

Participants will consume an unfermented oat-based product daily for three weeks within their diet.

Other: Unfermented oat-based product

Habitual diet

NO INTERVENTION

Participants consume their habitual diet without any intervention products.

Interventions

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.

Fermented product

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.

Unfermented product

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Eastern Finland: lead
• University of Turku: collaborator
• Umeå University: collaborator
• ETH Zurich: collaborator
• KU Leuven: collaborator

Study Sites (1)

University of Eastern Finland

Kuopio, 70210, Finland

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marjukka Kolehmainen

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: May 1, 2024
• Study Start: January 22, 2024
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

FI (1)