Investigation of Long-term Effects of CarelessTM on Microcirculation

Investigation of Long-term Effects of CarelessTM on Microcirculation in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Disease; Disorder of Circulatory System
• Intervention / Treatment: Dietary supplement: Mango fruit powder

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen, Germany, 73728
    • BioTeSys GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mango fruit powder 100mg	Dietary supplement: Mango fruit powder; Investigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design; Other Names: CarelessTM
Active Comparator: Mango fruit powder 300mg	Dietary supplement: Mango fruit powder; Investigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design; Other Names: CarelessTM
Placebo Comparator: Placebo formulation	Dietary supplement: Mango fruit powder; Investigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design; Other Names: CarelessTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of circulation	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.	Baseline at day 1 and after 4 weeks supplementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of glucose related biomarker	Measurement of Biomarker HOMA-Index, HbA1c at baseline and end of supplementation under fasting conditions.	Baseline at day 1 and after 4 weeks supplementation
Questionnaire on fatigue and vigor	Questionnaire on fatigue and vigor	Baseline at day 1 and after 4 weeks supplementation
Monitoring of adverse effects	Reporting of adverse effects to evaluate tolerability	During study execution over 4 weeks
Measurement of endothelial function using "EndoPATTM, Itamar"	Measurement of endothelial function using "EndoPATTM, Itamar"; Reactive hyperaemia index (RHI and lnRHI); Arterial stiffness (AI75) Delta change of endothelial function and arterial stiffness from baseline to end of supplementation is investigated. Additionally, the delta change of endothelial function from baseline to end of supplemen-tation postprandial is determined, which means the evaluation of postprandial effects on relative hy-peraemia index after glucose load.	Baseline at day 1 and after 4 weeks supplementation
Measurement of ox LDL	Measurement of ox LDL	Baseline at day 1 and after 4 weeks supplementation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Body weight and body fat (Body impedance analysis) determination	Baseline at day 1 and after 4 weeks supplementation
Blood glucose	Capillary blood glucose	Baseline at day 1 and after 4 weeks supplementation, before 1h and 2h after glucose loading

Collaborators and Investigators

• Sponsor: Vital Solutions Swiss AG
• Investigators: Study Chair: Claudia Reule, PhD, BioTeSys GmbH

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 24, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Estimate): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: BTS910/15