Investigation of Long-term Effects of CarelessTM on Microcirculation

Metabolic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588313
• Other study ID #: BTS910/15
• Status: Completed
• Phase: N/A
• First received: October 23, 2015
• Last updated: September 22, 2016
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2015
• Source: Vital Solutions Swiss AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Disorder of Circulatory System
• Metabolic Disease
• Metabolic Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	BioTeSys GmbH	Esslingen

Sponsors (1)

Lead Sponsor	Collaborator
Vital Solutions Swiss AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body composition	Body weight and body fat (Body impedance analysis) determination	Baseline at day 1 and after 4 weeks supplementation	No
Other	Blood glucose	Capillary blood glucose	Baseline at day 1 and after 4 weeks supplementation, before 1h and 2h after glucose loading	No
Primary	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	No
Secondary	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	No
Secondary	Questionnaire on fatigue and vigor	Questionnaire on fatigue and vigor	Baseline at day 1 and after 4 weeks supplementation	No
Secondary	Monitoring of adverse effects	Reporting of adverse effects to evaluate tolerability	During study execution over 4 weeks	Yes
Secondary	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	No
Secondary	Measurement of ox LDL	Measurement of ox LDL	Baseline at day 1 and after 4 weeks supplementation	No