Active — Not RecruitingNot Applicable

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

Finland72 participantsStarted 2022-09-12

Plain-language 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.

Who can participate

Age range30 Years – 68 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Changes from Baseline in Serum Total Cholesterol

Timeframe: Week 0 and Week 6

Changes from Baseline in Interleukin-10

Timeframe: Week 0 and Week 6

Trial details

NCT IDNCT05526092

SponsorUniversity of Turku

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More High Cholesterol/Hyperlipidemia trials