Vasoactive Effects of IQP-AS-118 in Healthy Individuals

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

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

Conditions
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Blood Flow, Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: IQP-AS-118
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IQP-AS-118<br>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<br>* 1 tablet in the morning<br>|
| Placebo Comparator: Placebo<br>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<br>* 1 tablet in the morning<br>|

What is the study measuring?
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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 |