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

NCT02871362 | Completed

• 1 other identifier: INQ/030915
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure; Low Density Lipoprotein Cholesterol Level

Outcome Measures

Primary Outcomes (1)

• Blood Pressure (Systolic & Diastolic)

  Week 12 vs. week 0

  12 weeks

Secondary Outcomes (14)

• Systolic blood pressure

  12 weeks

• Diastolic blood pressure

  12 weeks

• Fasting LDL-C concentration and non-HDL-C

  12 weeks

• Fasting TC Concentration

  12 weeks

• Fasting HDL-C Concentration

  12 weeks

Study Arms (2)

IQP-AS-118

EXPERIMENTAL

To be taken once daily with a glass of water. The tablets should not be chewed, but swallowed whole.

Dietary Supplement: IQP-AS-118

Placebo

PLACEBO COMPARATOR

To be taken once daily with a glass of water. The tablets should not be chewed, but swallowed whole.

Dietary Supplement: Placebo

Interventions

IQP-AS-118 DIETARY_SUPPLEMENT

Take one a day

IQP-AS-118

Placebo DIETARY_SUPPLEMENT

Take one a day

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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:
• 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 the past 5 years prior to screening
• Bleeding disorder and/or need for anticoagulants (anti-platelet agents are allowed)

Sponsors & Collaborators

• InQpharm Group: lead

Study Sites (1)

analyze & realize GmbH

Berlin, 10369, Germany

Location

Study Officials

• Ralf Uebelhack, MD, phD

  analyze & realize GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 18, 2016
• Study Start: March 17, 2017
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: March 4, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)