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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Chronic glucose metabolism
研究概览
简要总结
The effects of a 10g/day collagen hydrolysate for a period of 4 weeks on glycemic control and cardiovascular health in a parallel design study using overweight/ obese men and women who are likely to have a disturbed lipid and glucose metabolism and increased risk to develop cardiovascular disease and/or Type- 2 diabetes.
详细描述
Food-derived bioactive peptides represent a source of health-enhancing components that have been reported to have cardiovascular health benefits in humans and may be incorporated in functional foods. Up till now studies using collagen hydrolysates particularly addressed issues around joint health, however, there are some preliminary indications that other health-related targets might be affected as well. We here propose to focus on the potential effects of collagen hydrolysates on glycemic control, and characteristics of the microcirculation, both important parameters for the assessment of future cardiovascular disease (CVD) risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
The subjects will follow one of the two experimental conditions. The decision in which condition they will be placed is based upon a computer-generated table with random numbers. For this, a categorical list in logical order will be created by an independent person before the start of the study. After being found eligible to start the study, the subject gets the following study number that is on the list. Basically, this entire randomization process is blinded and follows the concealed allocation procedures. During this process, it will safeguard that there are equal group sizes and an equal number of men and women in both groups (range 40/60% or 60/40% is accepted).
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 40-75 years
- •Men and women (in a ratio of 40/60 to 60/40)
- •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 practitioner's community [Nederlands Huisartsen Genootschap])
- •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 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, autoinflammatory diseases, and rheumatoid arthritis
- •No active cardiovascular disease like congestive heart failure or cardiovascular events, 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 the 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 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, autoinflammatory diseases, and rheumatoid arthritis
- •Active cardiovascular diseases like congestive heart failure or cardiovascular events, 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
结局指标
主要结局
Chronic glucose metabolism
时间窗: pre- intervention and during the fourth week of intervention.
Measured by change in average daily glucose concentrations over a 15 hours period between waking up and going to bed 7:00-22:00 for three days, which is calculated based on the total area under the curve (tAUC) using a continuous glucose monitor.
次要结局
- Lipid metabolism(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and during the fourth week of intervention (visit 4, and 5))
- Glucose metabolism(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and during the fourth week of intervention (visit 4, and 5))
- Low-grade inflammation(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and during the fourth week of intervention (visit 4, and 5))
- Mood, degree of pleasantness and arousal(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5))
- Perceived Stress Scale(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5))
- Cognitive performance(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5))
- Venular and arteriolar diameters(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5))
- Office blood pressure(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and during the fourth week of intervention (visit 4, and 5))
- 36-hours blood pressure profiles(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and during the fourth week of intervention (visit 5))
- Sleep Quality(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5))
- Postprandial glucose metabolism(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5))
- Postprandial triacylglyceride metabolism(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5))
- Quality of life questionnaire(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), during (at home), and immediately after the intervention (visit 5))
- Tumor necrosis factor alfa(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and during the fourth week of intervention (visit 4, and 5))
- Chronic glucose metabolism(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and during the fourth week of intervention (visit 4, and 5))
- Insulin sensitivity(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and during the fourth week of intervention (visit 4, and 5))
- Cerebral blood flow (CBF)(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 3), and immediately after the intervention (visit 5))
- C-reactive Protein(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and during the fourth week of intervention (visit 4, and 5))
- C-peptide(2 weeks pre-intervention + 4 weeks intervention: Pre-intervention (visit 1,2 and 3), and during the fourth week of intervention (visit 4, and 5))