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Blood FlowNCT02871310

Vasoactive Effects of IQP-AS-118 in Healthy Individuals

A study testing IQP-AS-118 in people with Blood Flow and Cardiovascular Disease, run by InQpharm Group at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main objective of this study is to evaluate the benefit of IQP-AS-118 on the vasoactive effects in healthy subjects. Read more about this study

Who is it for?
Ages 45 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Blood Flow, Cardiovascular Disease
What is being tested?
IQP-AS-118
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteGermany
Study dates
Mar 2018to Dec 2018
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 45 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Caucasian males and females 45-65 years of age
  • Body mass index (BMI) of 25.0-29.9 kg/m2
  • Blood pressure (BP) at screening:
  • systolic blood pressure (SBP) ≤ 140 mmHg or
  • diastolic blood pressure (DBP) ≤ 90 mmHg
  • EndoPAT score: ≤ 2.00) at screening
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  • Generally in good health, in particular an electrocardiogram (ECG) without pathological findings at screening
  • Readiness to comply with study procedures, in particular:
  • Consumption of the investigational product (IP) / placebo according to investigator's advise
  • Maintaining the same level of physical activity and usual diet during the entire study
  • Accepting blood draws
  • Able to undergo an EndoPAT assessment
  • Complying with visits and all respective requirements for BP and EndoPAT measurements
  • Filling in diaries/questionnaires
  • Non-smoker since at least 6 months prior to screening and during the study
  • Stable body weight in the last 3 months prior to screening (<3 kg self-reported change) and during the study
  • Concomitant medications must have been stable at least during the last 1 month prior to screening, if applicable
  • In women: postmenopausal for at least 12 months Participation is based upon written informed consent form (ICF) by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.

Who cannot join

  • Known sensitivity to any components of the IP
  • Known primary or secondary hypertension or white-coat hypertension
  • Known impaired endothelial function as per investigator's judgement
  • Clinically significant disturbances in lipid metabolism e.g. known genetic hyperlipidemia
  • Known type-1 / type-2-diabetes
  • Untreated or non-stabilized thyroid disorder
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  • History and/or presence of clinically significant cardiovascular disease as per investigator's judgement:
  • Known congenital heart defects
  • Myocardial infarction, heart failure, angina pectoris, life-threatening arrhythmia or stroke within the last 6 months prior to screening
  • Existing thrombosis or disposition to thrombosis
  • Any other known significant or serious condition / disease that renders subjects ineligible, e.g.:
  • History of malignancy within ≤5 years prior to screening
  • Bleeding disorder and/or need for anticoagulants or anti-platelet agents
  • Current psychiatric care and/or use of neuroleptics
  • Bariatric surgery in the last 12 months prior to screening
  • Any known metabolic disease, gastrointestinal disorder or other clinically significant disease/disorder which in the investigator's opinion could interfere with the results of the study or the safety of the subject
  • Known arm lymphedema (e.g. due to mastectomy)
  • Other clinically relevant excursions of safety parameters or any other clinically significant abnormality in hematology and/or biochemistry at the Investigator's judgement
  • Dietary habits and/or restrictions that may affect the study outcome
  • Eating disorder or participation in a weight loss program
  • Use of medications (e.g. statins, renin angiotensin system inhibitors, nevibolol, carvedilol, calcium channel blockers) or supplements that can influence vascular endothelial function and/or blood flow (e.g. garlic, cocoa) within the last 4 weeks prior to screening and during the study
  • Use of antiplatelet agents and / or anticoagulants (e.g. warfarin, acetylsalicylic acid) within the last 4 weeks prior to screening and during the study
  • Use of medications or supplements that can influence SBP or DBP (e.g. ACE inhibitors, diuretics, calcium channel, α- or ß-blockers, grape seed extract, coenzyme Q10 etc.) within the last 4 weeks prior to screening and during the study
  • Use of lipid lowering medications (affecting lipid metabolism, platelet function or antioxidant status, etc.) and/or dietary supplements (e.g. omega-3 fatty acids, green tea extract, calcium, red yeast rice, phytosterols (incl. enriched products such as e.g. Becel), niacin,, glucomannan or chitosan ) within the last 4 weeks prior to screening and during the study
  • Use of medications that can influence cholesterol levels significantly (e.g. corticosteroids, amiodarone, estrogen, anabolic steroids) according to investigator's judgement
  • Use of weight loss treatment
  • Alcohol abuse (men: ≥21 units/week, women: ≥14 units/ week; 1 unit equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
  • Drug abuse
  • Reported participation in night shift work 2 weeks prior to screening and/or during the study
  • Participation in another study or blood donation during the last 30 days prior to screening and during the study
  • Any other reason deemed suitable for exclusion per investigator's judgment, e.g. insufficient compliance with study procedures

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • analyze & realize GmbH

    Berlin, 10369

Other trials in Germany

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Monocenter, Crossover Investigation to Evaluate the Vasoactive Effects of IQP-AS-118 in Healthy Individuals: A Pilot Study

The main objective of this study is to evaluate the benefit of IQP-AS-118 on the vasoactive effects in healthy subjects.

Being tested
IQP-AS-118, Placebo
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IQP-AS-118Dietary supplement

    1 tablet in the morning

  • PlaceboDietary supplement

    1 tablet in the morning

Study groups in NCT02871310
Study groupRoleWhat they receive
IQP-AS-118ExperimentalTo be taken once daily dosing of 1 tablet in the morning with 250 mL of water. The tablets should not be chewed, but swallowed whole.
Receives: Dietary Supplement: IQP-AS-118
PlaceboPlacebo comparatorTo be taken once daily dosing of 1 tablet in the morning with 250 mL of water. The tablets should not be chewed, but swallowed whole.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in EndoPAT (chronic effect)

    Pre-dose at the end vs. start of each intervention (week 4 vs. week 0 and week 12 vs. week 8, respectively) (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

Secondary outcomes (13)

  1. Change in EndoPAT (acute effect)

    3 h post-dose vs. pre-dose at start of each intervention (week 0 and week 8, respectively) (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

  2. Changes in ex vivo blood platelet aggregation / adhesion (acute effect)

    3 h post-dose vs. pre-dose at start of each intervention (week 0 and week 8, respectively) (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

  3. Changes in ex vivo blood platelet aggregation / adhesion pre-dose (chronic effect)

    End vs. start of each intervention (week 4 vs. week 0 and week 12 vs. week 8, respectively) (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

  4. Changes in blood coagulation / clotting parameters (acute effect)

    3 h post-dose vs. pre-dose at start of each intervention (week 0 and week 8, respectively) (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

  5. Changes in blood coagulation / clotting parameters predose (chronic effect)

    End vs. start of each intervention (week 4 vs. week 0 and week 12 vs. week 8, respectively) (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

  6. Global evaluation of benefit

    Assessed by the subjects and investigator at end of each intervention (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

  7. Changes in SF- 12

    End vs. start of each intervention (week 4 vs. week 0 and week 12 vs. week 8, respectively) (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

  8. Physical examination

    End of each intervention vs. screening (Week 4 vs. screening, week 12 vs. screening) (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

  9. Pulse rate

    End vs. start of each intervention (Week 4 vs. week 0, week 12 vs. week 8) (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

  10. Systolic Blood Pressure

    End vs. start of each intervention (Week 4 vs. week 0, week 12 vs. week 8) (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

  11. Diastolic Blood Pressure

    End vs. start of each intervention (Week 4 vs. week 0, week 12 vs. week 8) (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

  12. Assessment of Adverse Events

    Start and end of each intervention (Week 0, week 4, week 8 and week 12) (inclusive of 4 weeks of wash-out period)

    Measured: 12 weeks

  13. Global assessment of tolerability

    Assessed by the subjects and investigator (4-point categorical scale) at week 4 and week 12

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2016 (estimated)
  2. Study startMar 2018 (estimated)
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Why it stopped: Study discontinued

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02871310
Sponsor's protocol ID
INQ/030815
Status last verified
Jan 2018
First submitted
10 Aug 2016
Last updated
12 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing IQP-AS-118 in people with Blood Flow and Cardiovascular Disease, run by InQpharm Group 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 18 inclusion and 31 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: withdrawn, as of the sponsor's last update on 12 Feb 2020. 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 was withdrawn before enrolling participants, so there are no results.

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?

Change in EndoPAT (chronic effect) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02871310.

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 12 Feb 2020.

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