Vasoactive Effects of IQP-AS-118 in Healthy Individuals

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Disease; Blood Flow
• Intervention / Treatment: Dietary supplement: IQP-AS-118; Dietary supplement: Placebo

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10369
    • analyze & realize GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 1 tablet in the morning
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; 1 tablet in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 weeks
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)	12 weeks
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)	12 weeks
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)	12 weeks
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)	12 weeks
Global evaluation of benefit	Assessed by the subjects and investigator at end of each intervention (inclusive of 4 weeks of wash-out period)	12 weeks
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)	12 weeks
Physical examination	End of each intervention vs. screening (Week 4 vs. screening, week 12 vs. screening) (inclusive of 4 weeks of wash-out period)	12 weeks
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)	12 weeks
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)	12 weeks
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)	12 weeks
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)	12 weeks
Global assessment of tolerability	Assessed by the subjects and investigator (4-point categorical scale) at week 4 and week 12	12 weeks

Collaborators and Investigators

• Sponsor: InQpharm Group
• Investigators: Principal Investigator: Ralf Uebelhack, analyze & realize GmbH

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 14, 2016
• First Posted (Estimate): August 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: INQ/030815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No