Investigation of Long-term Effects of CarelessTM on Microcirculation in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Measurement of circulation
研究概览
简要总结
Aim of the study is to investigate long-term effects of CarelessTM, a Mangifera indica fruit powder on microcirculation and endothelial function after supplementation of 4 weeks. Effects will be investigated with 100mg and 300mg CarelessTM and compared to placebo.
详细描述
Aim of the study is to investigate long-term effects of CarelessTM, a Mangifera indica fruit powder on microcirculation and endothelial function after supplementation of 4 weeks. Effects will be investigated with 100mg and 300mg CarelessTM and compared to placebo.
To describe targeted parameter, cutaneous microcirculation will be measured at 1 mm depth as well as flow mediated endothelial function at the beginning and end of supplementation, each. Furthermore, the parameters will be determined postprandially 1 hour after glucose loading. Additionally the influence on the glucose metabolism, as well as on body weight and body fat will be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Men and postmenopausal women
- •HOMA Index ≥2 and <5
- •BMI: 19 - 30 kg/m2
- •Age ≥ 40 and ≤ 70 years
- •Nonsmoker
- •Written consent to participate in the study
- •Able and willing to follow the study protocol procedures
排除标准
- •Relevant history, presence of any medical disorder or chronic intake of medication/dietary sup-plements (e.g. polyphenols, L-Arginine, Niacin, medication of haemodilution, blood flow stimu-lating products like Aspirin (Acetylsalicylsäure), Clopidogrel (Adenosin-Diphosphat(ADP)-Inhibitors), Glykoprotein-IIb/IIIa-Inhibitors, Heparin, Marcumar (Vitamin K antagonists); Dabiga-tran (Faktor IIa synthese Inhibitors) Rivaroxaban (Faktor Xa Antagonist), Statins) potentially in-terfering with this study at screening.
- •For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening
- •Atopic dermatitis or affected skin at the forearm
- •Injury on the finger, influencing the EndoPATTM measurement
- •Regular consumption of caffeine > 275 mg (equivalent to 3-4 cups of coffee or 9 cups of black tea)
- •Change of dietary habits within the 2 weeks prior to screening (for instance start of a diet high in vegetables and fruits (≥ 5 portions per day))
- •Diet high in vegetables and fruits ≥ 5 portions per day
- •Participants anticipating a change in their lifestyle or physical activity levels during the study.
- •Subjects not willing to avoid polyphenol rich foods and abstain from beverages containing caf-feine the day prior to visit 1 and
- •Subjects not willing to abstain from intake of analgesic medication (e.g. Aspirin) 24 hours prior to and during visit 1 and
- •Sunbathing or the use of sun-beds 2 weeks prior to study days
- •Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
- •Known hypersensitivity to the study preparation or to single ingredients
- •Pregnant subject or subject planning to become pregnant during the study; breast-feeding sub-ject.
- •Known HIV-infection
- •Known acute or chronic hepatitis B and C infection
- •Blood donation within 4 weeks prior to visit 1 or during the study.
- •Subject involved in any clinical or food study within the preceding month
研究组 & 干预措施
Mango fruit powder 100mg
Mango fruit powder 100mg
干预措施: Mango fruit powder (Dietary Supplement)
Mango fruit powder 300mg
Mango fruit powder 300mg
干预措施: Mango fruit powder (Dietary Supplement)
Placebo formulation
Placebo formulation
干预措施: Mango fruit powder (Dietary Supplement)
结局指标
主要结局
Measurement of circulation
时间窗: Baseline at day 1 and after 4 weeks supplementation
Measurement of dermal microcirculation using "O2C, Lea Technik": * Relative peripheral blood flow (LDF) * Venous oxygen saturation (SO2 ven) * Relative amount of haemoglobin (rHb). Delta change of dermal microcirculation from baseline to end of supplementation is investigated. Addi-tionally, the delta change of dermal microcirculation from baseline to end of supplementation post-prandial is determined, which means the evaluation of postprandial effects on reactive hyperaemia index after glucose load.
次要结局
- Measurement of glucose related biomarker(Baseline at day 1 and after 4 weeks supplementation)
- Questionnaire on fatigue and vigor(Baseline at day 1 and after 4 weeks supplementation)
- Monitoring of adverse effects(During study execution over 4 weeks)
- Measurement of endothelial function using "EndoPATTM, Itamar"(Baseline at day 1 and after 4 weeks supplementation)
- Measurement of ox LDL(Baseline at day 1 and after 4 weeks supplementation)