MicrocirculationNCT02511899
Investigation of the Influence of Careless™, a Mangifera Indica Fruit Powder, on Microcirculation and Endothelial Function
A study testing Mango fruit powder in people with Microcirculation and Metabolism, run by Vital Solutions Swiss AG at 1 site in Germany.
Trial summary
Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit powder on cutaneous microcirculation and endothelial function. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microcirculation, Metabolism, Cardiovascular Disease
- What is being tested?
- Mango fruit powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Jul 2015
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology
- Healthy normal skin condition at the forearm
- BMI: 19-30 kg/m2
- Female
- Age ≥ 40 and ≤ 70 years
- Nonsmoker
- 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 supplements (e.g. polyphenols, L-Arginine, Niacin, medication of haemodilution, blood flow stimulating products like Aspirin) potentially interfering with this study at screening
- For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening
- Atopic dermatitis or affected skin at the forearm
- 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
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- Participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results
- Subjects not willing to avoid polyphenol rich foods and abstain from beverages containing caffeine 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
- Injury on the finger, influencing the EndoPAT™ measurement
- 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 product or to single ingredients
- Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
- 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
Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit powder on cutaneous microcirculation and endothelial function.
- Conditions
- Microcirculation, Metabolism, Cardiovascular Disease
- Being tested
- Mango fruit powder
- Keywords
- Microcirculation, Endothelial function, Metabolism, Cardiovascular Disease, human study, healthy subjects, Mangifera indica, Careless
- Medical subject headings
- Cardiovascular 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 Careless
Dietary supplement; Mango fruit powder
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta change of dermal microcirculation before and after intake (1h, 2h, 3h, 4h and 6h post) measured by O2C technology
Change over time for microcirculation
Measured: baseline before intake at the same day and 1hour, 2hour, 3hour, 4hour and 6hour post intake
Delta change of endothelial function using EndoPAT™ (baseline and 3hour post)
Changes over time of endothelial function
Measured: baseline before intake at the same day and 3 hours post intake
Secondary outcomes (1)
Tolerability, number of participants with adverse events
Measured: after 6 hours of intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies 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
- 10 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 director, BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511899
- Sponsor's protocol ID
- BTS850/15
- Status last verified
- Aug 2015
- First submitted
- 22 Jul 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Influence of Careless™, a Mangifera Indica Fruit Powder, on Microcirculation and Endothelial Function
- ClinicalTrials.gov ID
- NCT02511899
- Acronym / sponsor ID
- BTS850/15
- Conditions
- Microcirculation, Metabolism, Cardiovascular Disease
- Keywords
- Microcirculation, Endothelial function, Metabolism, Cardiovascular Disease, human study, healthy subjects, Mangifera indica, Careless
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vital Solutions Swiss AGIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 30 Jul 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.
Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit powder on cutaneous microcirculation and endothelial function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology
- Healthy normal skin condition at the forearm
- BMI: 19-30 kg/m2
- Female
Key exclusion criteria (18 listed)
- Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements (e.g. polyphenols, L-Arginine, Niacin, medication of haemodilution, blood flow stimulating products like Aspirin) potentially interfering with this study at screening
- For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening
- Atopic dermatitis or affected skin at the forearm
- 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))
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: CarelessDietary supplement; Mango fruit powder | Dietary supplement | Mango fruit powder 100mg, Mango fruit powder 300mg |
Primary outcome
Delta change of dermal microcirculation before and after intake (1h, 2h, 3h, 4h and 6h post) measured by O2C technology
Time frame: baseline before intake at the same day and 1hour, 2hour, 3hour, 4hour and 6hour post intake
Change over time for microcirculation
Delta change of endothelial function using EndoPAT™ (baseline and 3hour post)
Time frame: baseline before intake at the same day and 3 hours post intake
Changes over time of endothelial function
1 secondary outcome
Tolerability, number of participants with adverse events
Time frame: after 6 hours of intake
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 7 Aug 2015.
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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 director
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 Microcirculation and Metabolism, 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 18 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 7 Aug 2015. 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. 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?
Delta change of dermal microcirculation before and after intake (1h, 2h, 3h, 4h and 6h post) measured by O2C technology (time frame: baseline before intake at the same day and 1hour, 2hour, 3hour, 4hour and 6hour post intake). The study lists 2 primary outcomes in all. 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 7 Aug 2015.