NCT02871310

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 12, 2020

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

August 10, 2016

Last Update Submit

February 10, 2020

Conditions

Blood FlowCardiovascular Disease

Outcome Measures

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)

    12 weeks

Secondary Outcomes (13)

  • Change in EndoPAT (acute effect)

    12 weeks

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

    12 weeks

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

    12 weeks

  • Changes in blood coagulation / clotting parameters (acute effect)

    12 weeks

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

    12 weeks

  • +8 more secondary outcomes

Study Arms (2)

IQP-AS-118

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

IQP-AS-118DIETARY_SUPPLEMENT

1 tablet in the morning

IQP-AS-118
PlaceboDIETARY_SUPPLEMENT

1 tablet in the morning

Placebo

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +3 more criteria

You may not qualify if:

  • 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
  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

analyze & realize GmbH

Berlin, 10369, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Ralf Uebelhack

    analyze & realize GmbH

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 18, 2016

Study Start

March 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 12, 2020

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)