Clinical trial NCT02588313: Investigation of Long-term Effects of CarelessTM on Microcirculation
Official title: Investigation of Long-term Effects of CarelessTM on Microcirculation in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Circulatory System
Metabolic Disease
Lead sponsor: Vital Solutions Swiss AG
Sponsor class: INDUSTRY
First posted: 2015-10-27
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of circulation
timeFrame: Baseline at day 1 and after 4 weeks supplementation
Secondary outcomes:
measure: Measurement of glucose related biomarker
timeFrame: Baseline at day 1 and after 4 weeks supplementation
measure: Questionnaire on fatigue and vigor
timeFrame: Baseline at day 1 and after 4 weeks supplementation
measure: Monitoring of adverse effects
timeFrame: During study execution over 4 weeks
measure: Measurement of endothelial function using "EndoPATTM, Itamar"
timeFrame: Baseline at day 1 and after 4 weeks supplementation
measure: Measurement of ox LDL
timeFrame: Baseline at day 1 and after 4 weeks supplementation
Other outcomes:
measure: Body composition
timeFrame: Baseline at day 1 and after 4 weeks supplementation
measure: Blood glucose
timeFrame: Baseline at day 1 and after 4 weeks supplementation, before 1h and 2h after glucose loading
Locations:
city: Esslingen
country: Germany
facility: BioTeSys GmbH
Study officials:
affiliation: BioTeSys GmbH
name: Claudia Reule, PhD
role: STUDY_CHAIR
References: