OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals

NCT ID: NCT05526092

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-12
• Study Completion Date: 2027-12-31

Brief Summary

The overall objective of this research entity is to reveal the holistic health impact of oats in metabolically challenged individuals in a 6-week intervention, compared to that of rice. This is achieved by investigation of the plasma lipids, plasma antioxidant status, fecal microbiota and fecal bile acids. Additionally the effect of the 6-week diet on posptprandial glycemia and postprandial satiety and vitality are investigated.

Detailed Description

Aims in this 6-week randomised, single-blinded clinical trial, including a postprandial study at the 6 week time point, with metabolically challenged volunteers on oat-rich low-gluten diet, are to:

1. Compare effect of oat and rice rich diets to blood lipid and glucose status, perceived gut well-being and diet quality.

2. Investigate changes in microbiota, SCFAs, plasma antioxidant status and inflammation markers resulting from consumption of oat or rice rich low gluten diets.

3. Examine the impact of the oat and rice rich gluten free diet on the change in metabolite profiles in blood.

4. Find out the long-term effects of oat and rice consumption on recovery and vitality by modulating the gut-brain axis and measured with neuropsychological testing and using tryptophan metabolites as markers.

5. Discover how the long-term consumption of oats and rice and their possible alterations in gut microbiota affect subsequent postprandial glycaemia and response of microbiota to the meal (as seen in plasma SCFAs).

Conditions

High Cholesterol/Hyperlipidemia; High Blood Pressure; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Oat-rich and low-gluten diet

Participants will consume oats and oat products and follow low-gluten diet for 6 weeks.

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

Changes in metabolism, microbiota, vitality and comprehensive health after 6 week consumption of oat / rice.

Rice-rich and low-gluten diet

Participants will consume rice and rice products and follow low-gluten diet for 6 weeks.

Group Type: PLACEBO_COMPARATOR

Dietary intervention

Intervention Type: OTHER

Changes in metabolism, microbiota, vitality and comprehensive health after 6 week consumption of oat / rice.

Interventions

Dietary intervention

Changes in metabolism, microbiota, vitality and comprehensive health after 6 week consumption of oat / rice.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Commits to follow low-gluten diet for 6 weeks
• 30 - 68 years of age
• BMI > 25 kg/m^2
• High cholesterol AND/OR Hypertension

Exclusion Criteria

• Regular medication that can affect the gut
• Pregnancy or lactation
• Recent course of antibiotics (less than 3 months prior to the study)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turku

OTHER

Sponsor Role: lead

University of Eastern Finland

OTHER

Sponsor Role: collaborator

Responsible Party

Kaisa Linderborg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Food Sciences, Department of Life Technologies, University of Turku

Turku, Turku, Finland

Institute of Public Health and Clinical Nutrition, University of Eastern Finland

Kuopio, , Finland

Countries

Finland

Other Identifiers

OGB

Identifier Type: -

Identifier Source: org_study_id