Effects of Long-term Consumption of Two Plant-based Dietary Supplements on Low-grade Inflammation, Cardiovascular Disease Prevention and Circulating Micronutrients in a Cohort of Elderly Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Concentration changes in biomarkers of low-grade inflammation
研究概览
简要总结
Low- grade inflammation is a pathological feature of a wide range of chronic conditions, including the metabolic syndrome, cardiovascular diseases (CVD) and the accelerated reduction in bone density. Previous research shows that diets rich in fruits and vegetables can reduce chronic inflammation. To date there is no data on multiyear clinical interventions assessing the effect of plant-based dietary supplements on low-grade inflammation, cardiovascular disease prevention and indicators of biological aging, including individuals' cognitive function. In this study, the investigators are thus exploring whether separate ingestions of two plant-based nutritional products over 2 years, are able to modulate low-grade inflammation, parameters of CVD prevention, circulating micronutrients, upper respiratory tract- and gastro-intestinal symptoms, quality of life, indicators of biological aging, and cognitive function in overweight seniors.
详细描述
Inflammation is a central component of innate (non-specific) immunity. The termination of inflammation is an active process involving cytokines and anti-inflammatory mediators like lipids and micronutrients. Inflammation acts as both, 'friend and foe'; it is an essential component of immunosurveillance and host defense, but a chronic low-grade inflammatory state is a pathological feature of a wide range of chronic conditions, such as the metabolic syndrome or cardiovascular diseases (CVD). In addition, low-grade inflammation and oxidative stress are often associated with increased body fat mass, obesity but also accelerated reduction in bone density.
There is a substantial amount of evidence to suggest that many foods, nutrients and non-nutrient food components modulate inflammation both acutely and chronically. Nutritional regimens with adequate intake of micronutrients, vegetables, and fruits, low in sugar and saturated fats, like the Mediterranean diet or a vegetarian dietary regimen, can reduce chronic inflammation and oxidative stress.
To date there is no data on multiyear clinical interventions assessing the effect of plant-based dietary supplements on low-grade inflammation, cardiovascular disease prevention and indicators of biological aging, including individuals' cognitive function. In this study, the investigators are thus exploring whether separate ingestions of two plant-based nutritional products over 2 years, are able to modulate biomarkers of low-grade inflammation and CVD prevention, plasma concentrations of micronutrients, upper respiratory tract- and gastro-intestinal symptoms, quality of life, indicators of biological aging, and cognitive function in an overweight/obese cohort of middle-aged, elderly people.
Volunteers expressing interest to take part in the study, will need to attend a screening visit where their eligibility will be assessed. For participants with confirmed eligibility, they will need to attend a baseline visit and consecutive study visits at 6, 12, 18 and 24 months. Markers of low-grade inflammation and CVD, micronutrients status, respiratory tract symptoms, gastrointestinal symptoms and quality of life will be assessed at baseline, 6, 12, 18 and 24 months. Bone quality and telomere length will be assessed at baseline, 12 and 24 months.
Propensity score approach:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •90 male and female subjects
- •age: 50 - 80 years
- •post- or peri-menopausal
- •Smokers and non-smokers
- •BMI 25 to 40 kg/m2
- •Dietary Inflammatory Index, DII: 0 to +10
- •Fruit and vegetable intake <4 servings/d
- •Adherence to a 6-week "wash-out" period
- •Since the intervals between blood drawings are long (6 months), a temporary intake (e.g for a few days, one or two weeks) of some excluded drugs and food supplements does not necessarily mean exclusion from the study
排除标准
- •Age <50 and >79.9 years
- •Dietary Inflammatory Index, DII: - 0.1 to -10
- •Subjects with any kind of food allergy or histamine intolerance
- •Aversion to stop the intake of nutritional supplements and food, that could interfere with the study outcome
- •Food supplements, functional foods and dietetic products with anti-inflammatory or redox-biological relevance like omega-3 fatty acids, plant/herbal extracts/concentrates, vitamin- and mineral supplements
- •Fruit and vegetable intake >3 servings per day
- •Hypertension, starting with grade 2 according to the classification of the European Society of Hypertension: systolic blood pressure > 160 mmHg, diastolic blood pressure >100 mmHg
- •Medication: any anti-inflammatory medication and medication with relevant antioxidant properties, blood pressure lowering medication, psychotropic drugs, immunosuppressives, cytostatics, anticoagulants, contraceptives, diuretics, pain medication
- •Clinically relevant infectious disease
- •Diabetes mellitus type I and type II
- •Auto-immuno diseases
- •Any stents and Coronary artery diseases (CAD)
- •Cancer patients
- •Pregnancy
结局指标
主要结局
Concentration changes in biomarkers of low-grade inflammation
时间窗: 24 months
TNF-α, TNFsR2, TNFsR1, RANTES/ CCL5, IL-1β, osteoprotegerin (OPG)
Efficacy of micronutrients' absorption
时间窗: 24 months
Vitamin C, α-carotene, lycopene, ß-cryptoxanthin, α-tocopherol, vitamin A (retinol), ß-carotene, lutein/zeaxanthin, γ-tocopherol, vitamin D, vitamin K1, vitamin K2 (MK-7), matrix gla protein (MGP)
Plasma concentration changes in biomarkers of CVD
时间窗: 24 months
Homocysteine, oxLDL, Chol, HDL, LDL, Triglycerides, Apo A1, HOMA-IR, Insulin, Glucose, HbA1c, osteocalcin
次要结局
- Body mass assessment(24 months)
- Gastrointestinal symptoms survey (GISS-14)(24 months)
- Anthropometrics(24 months)
- Wisconsin upper respiratory symptoms survey (WURSS)(24 months)
- Quality of life(24 months)
研究者
Lamprecht Manfred PhD, PhD
Principal Investigator
Green Beat