NCT05526092

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

OAT-GUT-BRAIN: Comprehensive Health Effects of Long-term Consumption of Oats in Metabolically Challenged Volunteers - Gut-mediated Metabolomics and Vitality

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Turku · Academic / Other
• Sex: All
• Age: 30 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this research entity is to reveal the comprehensive 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 lipids, short-chain fatty acids, inflammation markers and antioxidant status from plasma, fecal microbiome, and plasma metabolome. Additionally the effect of the 6-week diet on postprandial glycemia and postprandial satiety and vitality are investigated.

Detailed description

Aims in this 6-week randomised, single-blinded clinical trial, including a postprandial study, 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 and general well-being and dietary intake. 2. Investigate changes in fecal microbiome, 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 or rice-rich low-gluten diet on the change in metabolite profiles in blood by non-targeted metabolomics approach. 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 biomarkers. 5. Discover how the long-term consumption of oats and rice and their possible alterations in fecal microbiome 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

Interventions

Type	Name	Description
OTHER	Dietary intervention	Changes in dietary intake, metabolism, fecal microbiome, vitality and perceived health after a 6-week consumption of oat or rice-rich low-gluten diet.
OTHER	Postprandial meal test	Postprandial changes after the 6-week consumption of either oat or rice-rich low-gluten diet, including blood markers, microbiome, satiety, recovery and vitality.

Timeline

• Start date: 2022-09-12
• Primary completion: 2023-12-31
• Completion: 2027-12-01
• First posted: 2022-09-02
• Last updated: 2026-04-13

Locations

2 sites across 1 country: Finland