Benefit of IQP-AS-118 on Blood Pressure and LDL-cholesterol

InQpharm

Status

Completed

Conditions

Low Density Lipoprotein Cholesterol Level

Blood Pressure

Treatments

Dietary Supplement: IQP-AS-118

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02871362

INQ/030915

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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:
- Consumption of the IP during the entire study
- Maintaining the habitual diet, with the exception of consumption of maximal 2 garlic cloves per week
- Accepting blood draws
- Complying with requirements for BP measurements (such as avoiding any strenuous exercise and stimulants (alcohol, caffeine) for at least 24 h before the measurement; refraining from extreme cold and heat exposure and food and fluid intake for at least 1 h before the measurement)
- Filling in health questionnaires
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:
1. negative pregnancy testing (ß-HCG in urine at screening)
2. commitment to use reliable contraception methods during the entire study 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
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:
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
Any other known significant or serious condition / disease that renders subjects ineligible, e.g.:
1. History of malignancy within the past 5 years prior to screening
2. Bleeding disorder and/or need for anticoagulants (anti-platelet agents are allowed)
3. Current psychiatric care and/or use of neuroleptics
4. 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 and/or deviations > 2 x ULN (upper limit of normal)
Dietary habits that may interfere with the study objectives:
1. Eating disorder
2. Subjects with dietary restriction that may affect the study outcome
3. Participation in a weight loss program
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.:
1. Insufficient compliance with study procedures
2. Inability to communicate with the site study staff