Investigation of Long-term Effects of CarelessTM on Microcirculation

Vital Solutions Swiss

Status: Completed

Conditions: Disorder of Circulatory System; Metabolic Disease

Treatments: Dietary Supplement: Mango fruit powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT02588313

BTS910/15

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Diabetes
• 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 2.
• Subjects not willing to abstain from intake of analgesic medication (e.g. Aspirin) 24 hours prior to and during visit 1 and 2.
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

Mango fruit powder 100mg

Active Comparator group

Description:

Mango fruit powder 100mg

Treatment:

Dietary Supplement: Mango fruit powder

Mango fruit powder 300mg

Active Comparator group

Description:

Mango fruit powder 300mg

Treatment:

Dietary Supplement: Mango fruit powder

Placebo formulation

Placebo Comparator group

Description:

Placebo formulation

Treatment:

Dietary Supplement: Mango fruit powder