NL-OMON50723已完成不适用
Effects of almond consumption on chronic glucose regulation, vascular function and cognitive performance: The AL-INCLUSIVE trial - Almonds and Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Aged between 40-75 years
- •- Men and women
- •- BMI between 25-40 kg/m2 (overweight and obese)
- •- Being classified as having prediabetes, either having impaired glucose
- •tolerance (IGT) and/or having impaired fasting glucose (IFG). IGT is defined
- •according the criteria of the WHO and American Diabetes Association (ADA) as
- •two-hour glucose concentrations of 7.8 to 11.0 mmol/l (140 to 199 mg per dL)
- •during the 75-g oral glucose tolerance test. IFG is defined as having a fasting
- •plasma glucose between 6.1 and 7.0 mmol/l (110 to 125 mg per dL) and a two-hour
- •glucose concentration below 7.8 mmol/l (140 mg per dL).
- •- Serum total cholesterol < 8.0 mmol/L (further testing is recommended for
- •excessive hyperlipidemia [serum total cholesterol * 8.0 mmol/L] according to
- •the Standard for cardiovascular risk management of the Dutch general
- •practitioners community [NHG])
- •- Serum triacylglycerol < 4.52 mmol/L
- •- No current smoker
- •- No diabetic patients
- •- No familial hypercholesterolemia
- •- No abuse of drugs
- •- Not more than 4 alcoholic consumption per day with a maximum of 21 per
- •- Stable body weight (weight gain or loss < 3 kg in the past three months)
- •- No use of medication known to treat blood pressure, lipid or glucose
- •- No use of an investigational product within another biomedical intervention
- •trial within the previous 1-month
- •- No severe medical conditions that might interfere with the study, such as
- •epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive
- •pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and
- •rheumatoid arthritis
- •- No active cardiovascular disease like congestive heart failure or
- •cardiovascular event, such as an acute myocardial infarction or cerebrovascular
- •- Willingness to give up being a blood donor from 8 weeks before the start of
- •the study, during the study and for 4 weeks after completion of the study
- •- No difficult venipuncture as evidenced during the screening visit
- •- Willing to comply to study protocol during study
- •- Informed consent signed
排除标准
- •- Allergy or intolerance to almonds
- •- Serum total cholesterol * 8.0 mmol/L
- •- Serum triacylglycerol * 4.52 mmol/L
- •- Current smoker, or smoking cessation <12 months
- •- Diabetic patients
- •- Familial hypercholesterolemia
- •- Abuse of drugs
- •- More than 4 alcoholic consumptions per day or 21 per week
- •- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- •- Use medication known to treat blood pressure, lipid or glucose metabolism
- •- Use of an investigational product within another biomedical intervention
- •trial within the previous 1-month
- •- Severe medical conditions that might interfere with the study, such as
- •epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive
- •pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and
- •rheumatoid arthritis
- •- Active cardiovascular disease like congestive heart failure or
- •cardiovascular event, such as an acute myocardial infarction or cerebrovascular
- •- Not willing to give up being a blood donor from 8 weeks before the start of
- •the study, during the study or for 4 weeks after completion of the study
- •- Not or difficult to venipuncture as evidenced during the screening visit
- •- Use of over-the-counter and prescribed medication or supplements, which may
- •interfere with study measurements to be judged by the principal investigator;
- •- Use of oral antibiotics in 40 days or less prior to the start of the study;
- •- Blood donation in the past 3 months before the start of the study
- •- Not willing to comply to study protocol during study or sign informed consent
研究者
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