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The purpose of this study is to evaluate the benefit and tolerability of IQP-AS-118 on the systolic and diastolic blood pressure (BP) and to explore the effects on parameters of lipid metabolism in subjects with elevated BP and low density lipoprotein cholesterol (LDL-C) levels in a pilot study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IQP-AS-118 | Experimental | To be taken once daily with a glass of water. The tablets should not be chewed, but swallowed whole. |
|
| Placebo | Placebo Comparator | To be taken once daily with a glass of water. The tablets should not be chewed, but swallowed whole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IQP-AS-118 | Dietary Supplement | Take one a day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure (Systolic & Diastolic) | Week 12 vs. week 0 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | Week 4 and week 8 vs. week 0, respectively | 12 weeks |
| Diastolic blood pressure | Week 4 and week 8 vs. week 0, respectively |
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Inclusion Criteria:
Caucasian males and females, 18-65 years of age
Body mass index (BMI) 18.5-29.9 kg/m2
Generally in good health, in particular an electrocardiogram (ECG) without pathological findings at screening
High normal BP levels (130-139 / 85-89) for 20% of randomized subjects and hypertension grade 1 (140-159 / 90-99) BP levels for 80% of randomized subjects at screening (mean of the 2nd and 3rd measurement during the assessment in triplicate at screening) and at baseline (mean of the 2nd and 3rd measurement during the assessment in triplicate at week 0)
LDL-C 100-159 mg/dL
Readiness to comply with study procedures, in particular:
Non-smoker / smoking cessation of last ≥12 months prior to screening
Stable body weight in the last 3 months prior to screening (<3 kg self-reported change)
If allowed concomitant medications are taken this must have been stable at least during the last month prior to screening
Women of child-bearing potential only:
Exclusion Criteria:
Known sensitivity to any components of the IP
Clinically significant disturbances in lipid metabolism
Known genetic hyperlipidemia
Known secondary hypertension
Known white-coat hypertension
Known type-1-diabetes
Uncontrolled or within the last 6 months prior to screening diagnosed 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 and/or deviations > 2 x ULN (upper limit of normal)
Dietary habits that may interfere with the study objectives:
Use of drugs or supplements that can influence SBP or DBP (e.g. ACE inhibitors, diuretics, calcium channel 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 drugs (affecting lipid metabolism, platelet function or antioxidant status, etc.) OR dietary or health supplements (e.g. omega-3 fatty acids, green tea extract, calcium, red yeast rice, phytosterols (incl. enriched products such as e.g. Becel), oat fiber, niacin, soy protein, psyllium seed husk, glucomannan, chitosan or probiotics/prebiotics) within the last 4 weeks prior to screening and during the study
Use of drugs that can influence cholesterol levels (e.g. corticosteroids, amiodarone, estrogen, anabolic ster-oids)
Use of weight loss treatment
Use of any recreational drugs
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)
Women of child-bearing potential: pregnant or breast-feeding
Participation in another study or blood donation during the last 30 days prior to screening
Any other reason deemed suitable for exclusion as per investigator's judgment, e.g.:
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Uebelhack, MD, phD | analyze & realize GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| analyze & realize GmbH | Berlin | 10369 | Germany |
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| Dietary Supplement |
Take one a day |
|
| 12 weeks |
| Fasting LDL-C concentration and non-HDL-C | Week 12 vs. week 0 | 12 weeks |
| Fasting TC Concentration | Week 12 vs. week 0 | 12 weeks |
| Fasting HDL-C Concentration | Week 12 vs. week 0 | 12 weeks |
| Fasting TG Concentration | Week 12 vs. week 0 | 12 weeks |
| Fasting LDL-C/HDL-C and TC/HDL-C ratio | Week 12 vs. week 0 | 12 weeks |
| Fasting Lp (a) concentrations | Week 12 vs. week 0 | 12 weeks |
| hs-CRP | Week 12 vs. Screening | 12 weeks |
| Homocysteine | Week 12 vs. Screening | 12 weeks |
| Pulse wave assessment | Week 12 vs. week 0 | 12 weeks |
| Metabolome analysis | Week 12 vs. week 0 | 12 weeks |
| SF-12 | Week 4, week 9 and week 12 vs. week 0, respectively | 12 weeks |
| Global evaluation of benefit by the subjects/ investigator | Week 12 only | 12 weeks |