Effects of oat consumption on metabolism and gut microbiome in individuals with metabolic syndrome – a human dietary intervention trial

Not Applicable

• Conditions: E88.9; Metabolic disorder, unspecified

• Registration Number: DRKS00022169
• Lead Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn Institut für Ernährungs- und Lebensmittelwissenschaften/ Abteilung Ernährung und Mikrobiota

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-28
• Results First Posted: 2021-12-01
• Study Completion: 2022-07-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

BMI 27-39,9 kg/m²; metabolic syndrome: visceral fat distribution, measured by waist circumference (?: = 80 cm; ?: = 94 cm) + two of the following risk factors: prehypertension (= 120-139 mmHg systolic and/ or = 80-89 mmHg diastolic) or hypertension state 1 (= 140-159 mmHg systolic and/ or = 90-99 mmHg diastolic), triglyceridemia (= 1,7 mmol/L), low HDL-cholesterol (?: < 1,3 mmol/L; ?: < 1,0 mmol/L), hyperglycemia (> 5,6 mmol/l);
Non-smoker (for at least 3 months),
written declaration of consent for participation in the study.
The limit values for waist circumference, triglycerides and HDL cholesterol (all under fasting conditions) correspond to the parameters of metabolic syndrome according to the International Diabetes Federation (IDF). Blood pressure was based on the American classification.

Exclusion Criteria

Regular oat intake (at least 1 usual portion/week); Taking medications that affect glucose metabolism; diagnosed T2DM, chronic hepatic diseases (Transaminases > Twice the standard value), gastrointestinal diseases, chronic inflammatory diseases (hs-CRP > 30 mg/L), cardiovascular events, thyroid disease, tumour diseases, acute diseases or recent operations; Pregnancy, breastfeeding period; allergies and intolerances to oat products; antibiotic therapy 3 weeks before the start of the study; alcohol and drug abuse; regular intake of supplements (n-3 fatty acids, vitamin E, magnesium, calcium, iron); Planned lifestyle change; vegetarian or vegan diet; participation in another clinical trial simultaneously/in the last 30 days; sensory or motor problems that make it impossible to use the neotiv app; other exclusion criteria at the discretion of the doctor/investigator.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentration of (dihydro-)ferulic acid (measurement is carried out before the intervention (baseline), during and after the intervention phase. Blood is taken under fasting conditions.)

Secondary Outcome Measures

Name	Time	Method
concentration of oat phenolics in blood, urine and fecal samples (Avenanthramides as compliance marker, untargeted analysis), intestinal microbiome (composition, diversity), concentration of various intestinal hormones (GLP-1, GLP-2, GIP, ghrelin), parameter of intestinal permeability (zonulin), parameter of glucose and lipid metabolism (glucose, insulin, HbA1c, lipids, lipoproteins, FFS), parameter of inflammation, neuroinflammation and antioxidative defence (IL-6, TNF-a, CRP, NFL, vitamin A, E, ß-carotene, vitamin C, oxLDL), SCFAs (serum, fecal), amino acids (tryptophan, tyrosine), serotonin, electrolytes (sodium, potassium, magnesium); <br>Further parameters: anthropometrics (body weight, body height, waist and hip ratio, body composition (BodPod), resting energy expenditure (QuarkRMR), cognition + concentration and mental state (questionnaire, digital tests); <br>Security parameters: Small blood count, Parameters of renal and hepatic function (GOT, GPT, GGT, bilirubin, uric acid, urea, creatinine).