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WithdrawnNCT02871310Updated Feb 12, 2020

Vasoactive Effects of IQP-AS-118 in Healthy Individuals

An interventional study of IQP-AS-118 and Placebo in Blood Flow and Cardiovascular Disease, sponsored by InQpharm Group. Withdrawn at 1 site in Germany. Open to participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-12.

Sponsored by InQpharm Group · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Study discontinued
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Blood Flow
  • Cardiovascular Disease
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

Browse Cardiovascular Diseases studies →

Lead sponsor

InQpharm Group is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Caucasian males and females 45-65 years of age
  2. Body mass index (BMI) of 25.0-29.9 kg/m2
  3. Blood pressure (BP) at screening:

    • systolic blood pressure (SBP) ≤ 140 mmHg or
    • diastolic blood pressure (DBP) ≤ 90 mmHg
  4. EndoPAT score: ≤ 2.00) at screening
  5. Generally in good health, in particular an electrocardiogram (ECG) without pathological findings at screening
  6. 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
  7. Non-smoker since at least 6 months prior to screening and during the study
  8. Stable body weight in the last 3 months prior to screening (\<3 kg self-reported change) and during the study
  9. Concomitant medications must have been stable at least during the last 1 month prior to screening, if applicable
  10. 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.

Exclusion criteria

Exclusion Criteria:

  1. Known sensitivity to any components of the IP
  2. Known primary or secondary hypertension or white-coat hypertension
  3. Known impaired endothelial function as per investigator's judgement
  4. Clinically significant disturbances in lipid metabolism e.g. known genetic hyperlipidemia
  5. Known type-1 / type-2-diabetes
  6. Untreated or non-stabilized thyroid disorder
  7. History and/or presence of clinically significant cardiovascular disease as per investigator's judgement:

    1. Known congenital heart defects
    2. Myocardial infarction, heart failure, angina pectoris, life-threatening arrhythmia or stroke within the last 6 months prior to screening
    3. Existing thrombosis or disposition to thrombosis
  8. Any other known significant or serious condition / disease that renders subjects ineligible, e.g.:

    1. History of malignancy within ≤5 years prior to screening
    2. Bleeding disorder and/or need for anticoagulants or anti-platelet agents
    3. Current psychiatric care and/or use of neuroleptics
    4. Bariatric surgery in the last 12 months prior to screening
  9. 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
  10. Known arm lymphedema (e.g. due to mastectomy)
  11. Other clinically relevant excursions of safety parameters or any other clinically significant abnormality in hematology and/or biochemistry at the Investigator's judgement
  12. Dietary habits and/or restrictions that may affect the study outcome
  13. Eating disorder or participation in a weight loss program
  14. 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
  15. Use of antiplatelet agents and / or anticoagulants (e.g. warfarin, acetylsalicylic acid) within the last 4 weeks prior to screening and during the study
  16. 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
  17. 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
  18. Use of medications that can influence cholesterol levels significantly (e.g. corticosteroids, amiodarone, estrogen, anabolic steroids) according to investigator's judgement
  19. Use of weight loss treatment
  20. 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)
  21. Drug abuse
  22. Reported participation in night shift work 2 weeks prior to screening and/or during the study
  23. Participation in another study or blood donation during the last 30 days prior to screening and during the study
  24. Any other reason deemed suitable for exclusion per investigator's judgment, e.g. insufficient compliance with study procedures
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    IQP-AS-118

    To 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.

    Dietary Supplement: IQP-AS-118

  • Placebo comparator
    Placebo

    To 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.

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementIQP-AS-118

    1 tablet in the morning

  • Dietary supplementPlacebo

    1 tablet in the morning

06

What researchers measure

Primary outcomes

  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)

    Time frame: 12 weeks

Secondary outcomes

  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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 12 weeks

  13. Global assessment of tolerability

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

    Time frame: 12 weeks

07

Study locations

1 site
  • analyze & realize GmbH
    Berlin, 10369, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02871310
Lead sponsor
InQpharm Group
Responsible party
Sponsor
First posted
Aug 18, 2016
Start date
Mar 2018 (estimated)
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Feb 12, 2020

Study contacts

Ralf Uebelhack
principal investigator · analyze & realize GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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