Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05526092

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 68 Years

SexAll

Healthy volunteersNot accepted

ConditionHigh Cholesterol/Hyperlipidemia, High Blood Pressure, Overweight and Obesity

Full registry criteria

Inclusion Criteria: * Commits to follow the instructed low-gluten diet for 6 weeks * 30 - 68 years of age * BMI \> 25 kg/m\^2 * High cholesterol (without medication) characterized as total cholesterol \> 5 mmol/l, AND either LDL \> 3 mmol/l OR HDL (men/women) \< 1.0/1.2 mmol/l AND/OR Hypertension (systolic \> 140 mmHg or diastolic \> 90 mmHg). Exclusion Criteria: * Regular medication that can affect the research outcomes (balanced medication for hypertension, hypo-/hyperthyroidism, hormone replacement therapy, and inhaled medicines allowed) * Pregnancy or lactation * Heavy smoking * Recent course of antibiotics (less than 3 months prior to the study)

Treatments and study arms

Dietary intervention

Other

Changes in dietary intake, metabolism, fecal microbiome, vitality and perceived health after a 6-week consumption of oat or rice-rich low-gluten diet.

Postprandial meal test

Other

Postprandial changes after the 6-week consumption of either oat or rice-rich low-gluten diet, including blood markers, microbiome, satiety, recovery and vitality.

Primary outcomes

Changes from Baseline in Serum Total CholesterolWeek 0 and Week 6

Serum total cholesterol will be measured from fasting blood samples at the baseline (week 0) and after 6 week of the dietary intervention (week 6).

Changes from Baseline in Interleukin-10Week 0 and Week 6

Interleukin-10 is measured from fasting plasma samples at the baseline (week 0) and after the 6-week diet intervention (week 6). It will be analysed as part of the Olink Target 48 Cytokine Panel (Olink Proteomics, Uppsala, Sweden) that provides absolute quantities for 45 different proteins, such as interleukins, interferons, chemokines and growth factors that are related to inflammation.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Institute of Public Health and Clinical Nutrition, University of Eastern Finland🇫🇮 Kuopio, Finland

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Food Sciences, Department of Life Technologies, University of Turku🇫🇮 Turku, Turku, Finland

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