Disorder of Circulatory SystemNCT02588313
Investigation of Long-term Effects of CarelessTM on Microcirculation
A study testing Mango fruit powder in people with Disorder of Circulatory System and Metabolic Disease, run by Vital Solutions Swiss AG at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Circulatory System, Metabolic Disease
- What is being tested?
- Mango fruit powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Disorder of Circulatory System, Metabolic Disease
- Being tested
- Mango fruit powder
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mango fruit powderDietary supplement
Also called CarelessTM
Investigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design
| Study group | Role | What they receive |
|---|---|---|
| Mango fruit powder 100mg | Active comparator | Mango fruit powder 100mg Receives: Dietary Supplement: Mango fruit powder |
| Mango fruit powder 300mg | Active comparator | Mango fruit powder 300mg Receives: Dietary Supplement: Mango fruit powder |
| Placebo formulation | Placebo comparator | Placebo formulation Receives: Dietary Supplement: Mango fruit powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline at day 1 and after 4 weeks supplementation
Secondary outcomes (5)
Measurement of glucose related biomarker
Measurement of Biomarker HOMA-Index, HbA1c at baseline and end of supplementation under fasting conditions.
Measured: Baseline at day 1 and after 4 weeks supplementation
Questionnaire on fatigue and vigor
Questionnaire on fatigue and vigor
Measured: Baseline at day 1 and after 4 weeks supplementation
Monitoring of adverse effects
Reporting of adverse effects to evaluate tolerability
Measured: 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.
Measured: Baseline at day 1 and after 4 weeks supplementation
Measurement of ox LDL
Measurement of ox LDL
Measured: Baseline at day 1 and after 4 weeks supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Circulatory SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vital Solutions Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudia Reule, PhD, Study chair, BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588313
- Sponsor's protocol ID
- BTS910/15
- Status last verified
- Oct 2015
- First submitted
- 23 Oct 2015
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Long-term Effects of CarelessTM on Microcirculation in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design
- ClinicalTrials.gov ID
- NCT02588313
- Acronym / sponsor ID
- BTS910/15
- Conditions
- Disorder of Circulatory System, Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Vital Solutions Swiss AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mango fruit powder 100mg | Active comparator | Dietary Supplement: Mango fruit powderMango fruit powder 100mg |
| Mango fruit powder 300mg | Active comparator | Dietary Supplement: Mango fruit powderMango fruit powder 300mg |
| Placebo formulation | Placebo comparator | Dietary Supplement: Mango fruit powderPlacebo formulation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy volunteers
- Men and postmenopausal women
- HOMA Index ≥2 and <5
- BMI: 19 - 30 kg/m2
- Age ≥ 40 and ≤ 70 years
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mango fruit powderAlso: CarelessTMInvestigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design | Dietary supplement | Mango fruit powder 100mg, Mango fruit powder 300mg, Placebo formulation |
Primary outcome
Measurement of circulation
Time frame: Baseline at day 1 and after 4 weeks supplementation
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.
5 secondary outcomes
Measurement of glucose related biomarker
Time frame: Baseline at day 1 and after 4 weeks supplementation
Questionnaire on fatigue and vigor
Time frame: Baseline at day 1 and after 4 weeks supplementation
Monitoring of adverse effects
Time frame: During study execution over 4 weeks
Measurement of endothelial function using "EndoPATTM, Itamar"
Time frame: Baseline at day 1 and after 4 weeks supplementation
Measurement of ox LDL
Time frame: Baseline at day 1 and after 4 weeks supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Reule, PhD study chair
BioTeSys GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mango fruit powder in people with Disorder of Circulatory System and Metabolic Disease, run by Vital Solutions Swiss AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of circulation (time frame: Baseline at day 1 and after 4 weeks supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.