Clinical trial NCT05526092: OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals
Official title: OAT-GUT-BRAIN: Comprehensive Health Effects of Long-term Consumption of Oats in Metabolically Challenged Volunteers - Gut-mediated Metabolomics and Vitality
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: High Cholesterol/Hyperlipidemia
High Blood Pressure
Overweight and Obesity
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2022-09-02
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

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)

Primary outcomes:
measure: Changes from baseline in plasma short-chain fatty acids
timeFrame: Week 0 and 6
measure: Changes from baseline in plasma antioxidant capasity
timeFrame: Week 0 and 6
measure: Changes in blood lipid
timeFrame: Week 0 and 6
measure: Changes in glucose status
timeFrame: Week 0 and 6
measure: Changes in inflammation markers
timeFrame: Week 0 and 6
measure: Changes in neuropsychological performance: cognitive load
timeFrame: Week 0 and 6
measure: Changes in neuropsychological performance: reaction time and attention
timeFrame: Week 0 and 6
measure: Changes in neuropsychological performance: response control
timeFrame: Week 0 and 6
Secondary outcomes:
measure: Changes in gastrointestinal symptoms
timeFrame: Weeks 0 and 6
measure: Changes in gut microbiota
timeFrame: Week 0 and 6
measure: Changes in excreted bile acids
timeFrame: Week 0 and 6
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Institute of Public Health and Clinical Nutrition, University of Eastern Finland
city: Turku
country: Finland
facility: Food Chemistry and Food Development, Department of Life Technologies, University of Turku
Study officials:
References: