β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- change in total and LDL cholesterol concentration
研究概览
简要总结
The aim of this study is to investigate the potential disease preventive effects of β-glucans from oat and barley.
详细描述
Objective:
The primary aim is to examine whether consumption of oat and two different barley β-glucans exhibits hypocholesterolemic effects and to understand the underlying mechanisms.
Secondary aims are to investigate whether there are also effects on blood pressure, appetite regulation, insulin sensitivity, hemostasis, low-grade inflammation and the metabolic profile of different biological materials.
Intervention:
In each of the 4 intervention periods the participants drink a milk drink together with their three main meals for 21 days. This way they consume 5g β-glucan/d form either oat or barley in the three treatment periods, otherwise they maintain their habitual diet. They are not, however, allowed to eat any oat- or barley-containing products during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •normal weight or moderately overweight (BMI 18.5-30 kg/m²)
排除标准
- •chronic diseases (e.g. diabetes, cardiovascular disease)
- •elevated blood pressure
- •hyperlipidemia
- •consumption of dietary supplements during or 2 month prior to start of study (including vitamin tablets)
- •consumption of oat and barley products from January 1st until the end of study
- •excess physical activity (> 8h/week)
- •medicine use (not included contraceptives or occasional pain killer consumption)
- •pregnancy
- •breast feeding
结局指标
主要结局
change in total and LDL cholesterol concentration
时间窗: fasting blood sample at baseline and day 21
pH, SCFA, bile acids, total fat, total energy, cholesterol (in 72h feces)
时间窗: average over three days at baseline and after 3 weeks
weight
时间窗: at baseline and after 1, 2 and 3 weeks
food intake (in 4d records)
时间窗: at baseline and after 3 weeks
height
时间窗: at baseline
次要结局
- insulin, glucose, IL-6, CRP, TNF-α, fibrinogen, PAI-1, appetite regulation peptides, alkylresorcinol, metabolomics (in fasting and meal test blood samples)(fasting blood sample at baseline and on day 21)
- appetite sensation (in meal tests)(3h appetite registrations at baseline and on day 21)
- metabolomics, isoprostanes (in 24h urine)(at baseline and after 3 weeks)
- metabolomics (in 72h feces)(average over 3 days at baseline and after 3 weeks)
- blood pressure(at baseline and on day 21)