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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.
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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:
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:
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:
Any other known significant or serious condition / disease that renders subjects ineligible, e.g.:
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
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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