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临床试验/DRKS00022169
DRKS00022169已完成未知

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

Rheinische Friedrich-Wilhelms-Universität Bonn Institut für Ernährungs- und Lebensmittelwissenschaften/ Abteilung Ernährung und Mikrobiota0 个研究点目标入组 68 人开始时间: 2020年7月28日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
68

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
45 Years 至 70 Years(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
Rheinische Friedrich-Wilhelms-Universität Bonn Institut für Ernährungs- und Lebensmittelwissenschaften/ Abteilung Ernährung und Mikrobiota

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