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临床试验/NCT04763291
NCT04763291进行中(未招募)不适用

Effects of Long-term Consumption of Two Plant-based Dietary Supplements on Cardiovascular Health and Low-grade Inflammation in the Elderly

Green Beat4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
80
试验地点
4
主要终点
Lipid profile markers

研究概览

简要总结

Evidence from previous studies supports a strong relationship between fruit and vegetable consumption and reduced cardiac risk. This could be mediated via improvements on blood pressure, platelet function and vascular reactivity. Certain vitamins and polyphenols found in fruits and vegetables, have antioxidant and anti-inflammatory effects and play a major role on the function of immune cells. Previous studies have also demonstrated the importance of omega-3 fatty acids on humans' health and their positive effects on the cardiovascular system and blood lipids regulation, as well as their involvement on inflammatory response. Nutritional regimens with adequate intake of micronutrients, fruit and vegetables, omega-3 fatty acids, low in sugar and saturated fats, such as the Mediterranean diet or vegetarian diets, can reduce chronic inflammation and oxidative stress and improve cardiovascular risk profile. Considering that the population's fruit and vegetable and omega-3 intakes are below recommendations, whole food-based supplements could provide an accessible form of supplementation to bridge the gap between actual and recommended intakes. This study is aiming to assess whether long-term separate ingestions of an encapsulated juice powder concentrate and a plant-based omega fatty acid supplement, or a combined ingestion of the two, can affect biomarkers of cardiovascular health, low-grade inflammation and indicators of biological aging in older adults.

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
None

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Post menopausal
  • Non-smokers
  • BMI 18.5 to 40 kg/m2
  • Vegetable intake ≤ 2 servings/ day
  • Intake of fruits ≤ 2 servings /day
  • Adherence to a 6-week washout period for dietary supplements not ingested for specific medical conditions.

排除标准

  • Age <55 and >80 years
  • Smokers (or ex-smokers who quit smoking less than 3 years ago)
  • Aversion to stop the intake of multivitamins, multiminerals or omega fatty acid supplements
  • Subjects with histamine intolerance
  • Hypertension, starting with grade 2 according to the classification of the European Society of Hypertension: systolic blood pressure > 160mmHg, diastolic blood pressure >100 mmHg
  • All medication taken for less than 3 months or with changes on the dosage over the last 3 months and medication for any of the conditions listed below.
  • Clinically relevant infectious diseases
  • Diabetes mellitus type I and type II
  • Rheumatic diseases
  • Auto-immune diseases
  • Any stents and coronary artery diseases (CAD)
  • Cancer patients
  • Pregnancy
  • Significant lifestyle changes, e.g. changes in diet or physical activity profile

结局指标

主要结局

Lipid profile markers

时间窗: 12 months

Total cholesterol, HDL, LDL, ApoA1, triglycerides, Omega-3-Index

Concentration changes in cytokines/ cytokine receptors

时间窗: 12 months

TNF-α, sTNFR1 and sTNFR2, CCL5 = RANTES, IL-1β, hsCRP, CCL2 = MCP-1, Osteoprotegerin (OPG), IL-5, IL-8

Oxidative stress markers

时间窗: 12 months

oxLDL, MDA, carbonyl proteins, (CP), redox state of albumin, homocysteine

Glucose metabolism

时间窗: 12 months

Glucose, insulin, HOMA-IR, HbA1c

Hemostasis markers

时间窗: 12 months

Platelet aggregation, thrombelastometry, coagulation (Quick, PT, PTT)

次要结局

  • Vitamin K metabolism(12 months)
  • mitochondrial DNA copy number (mtDNA-CN)(12 months)
  • Upper respiratory tract symptoms(12 months)
  • Quality of life Questionnaire(12 months)
  • Neurotrophins(12 months)
  • Cognitive function(12 months)

研究者

发起方
Green Beat
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lamprecht Manfred PhD, PhD

Principal Investigator

Green Beat

研究点 (4)

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