Investigation of Long-term Effects of CarelessTM on Microcirculation

NCT02588313 | Completed

• 1 other identifier: BTS910/15
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Circulatory System; Metabolic Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Other Outcomes (2)

• Body composition

  Baseline at day 1 and after 4 weeks supplementation

• Blood glucose

  Baseline at day 1 and after 4 weeks supplementation, before 1h and 2h after glucose loading

Study Arms (3)

Mango fruit powder 100mg

ACTIVE COMPARATOR

Mango fruit powder 100mg

Dietary Supplement: Mango fruit powder

Mango fruit powder 300mg

ACTIVE COMPARATOR

Mango fruit powder 300mg

Dietary Supplement: Mango fruit powder

Placebo formulation

PLACEBO COMPARATOR

Placebo formulation

Dietary Supplement: Mango fruit powder

Interventions

Mango fruit powder DIETARY_SUPPLEMENT

Investigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design

Also known as: CarelessTM

Mango fruit powder 100mg; Mango fruit powder 300mg; Placebo formulation

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vital Solutions Swiss AG: lead

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Location

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Claudia Reule, PhD

  BioTeSys GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 23, 2016

Record last verified: 2015-10

Locations

DE (1)