NL-OMON56269已完成不适用
Effects of 10 gram collagen protein hydrolysate on cardiometabolic health in obese (BMI 25-35 kg/m2) men and women with elevated risk to develop Type-2 diabetes and CVD - Collagen peptides and glycemic control
Voeding en Bewegingswetenschappen0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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 25-35 kg/m2 - 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 < 4.5 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 week?? -
- •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 metabolism
- •- No use of an investigational product within another biomedical intervention
- •in the previous 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 accident - 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 - Agree to take porcine / animal derived supplements (i.e.
- •collagen) - Informed consent signed
排除标准
- •- Allergy or intolerance to collagen or collagen hydrolysates - Serum total
- •cholesterol >= 8.0 mmol/L - Serum triacylglycerol >= 4.5 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 in another biomedical
- •intervention within the previous 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 accident - 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 - Not willing to
- •consume the collagen hydrolysate because this is from animal origin
研究者
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