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Blood PressureNCT02871362

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

A study testing IQP-AS-118 in people with Blood Pressure and Low Density Lipoprotein Cholesterol Level, run by InQpharm Group at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
IQP-AS-118
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteGermany
Study dates
17 Mar 2017to 30 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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:
  • negative pregnancy testing (ß-HCG in urine at screening)
  • 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.

Who cannot join

  • 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
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  • 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)
  • 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 and/or deviations > 2 x ULN (upper limit of normal)
  • Dietary habits that may interfere with the study objectives:
  • Eating disorder
  • Subjects with dietary restriction that may affect the study outcome
  • 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.:
  • Insufficient compliance with study procedures
  • Inability to communicate with the site study staff

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • analyze & realize GmbH

    Berlin, 10369

Other trials in Germany

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of IQP-AS-118 on Blood Pressure and LDL-cholesterol: A Pilot Study

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.

Being tested
IQP-AS-118, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IQP-AS-118Dietary supplement

    Take one a day

  • PlaceboDietary supplement

    Take one a day

Study groups in NCT02871362
Study groupRoleWhat they receive
IQP-AS-118ExperimentalTo be taken once daily with a glass of water. The tablets should not be chewed, but swallowed whole.
Receives: Dietary Supplement: IQP-AS-118
PlaceboPlacebo comparatorTo be taken once daily with a glass of water. The tablets should not be chewed, but swallowed whole.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure (Systolic & Diastolic)

    Week 12 vs. week 0

    Measured: 12 weeks

Secondary outcomes (14)

  1. Systolic blood pressure

    Week 4 and week 8 vs. week 0, respectively

    Measured: 12 weeks

  2. Diastolic blood pressure

    Week 4 and week 8 vs. week 0, respectively

    Measured: 12 weeks

  3. Fasting LDL-C concentration and non-HDL-C

    Week 12 vs. week 0

    Measured: 12 weeks

  4. Fasting TC Concentration

    Week 12 vs. week 0

    Measured: 12 weeks

  5. Fasting HDL-C Concentration

    Week 12 vs. week 0

    Measured: 12 weeks

  6. Fasting TG Concentration

    Week 12 vs. week 0

    Measured: 12 weeks

  7. Fasting LDL-C/HDL-C and TC/HDL-C ratio

    Week 12 vs. week 0

    Measured: 12 weeks

  8. Fasting Lp (a) concentrations

    Week 12 vs. week 0

    Measured: 12 weeks

  9. hs-CRP

    Week 12 vs. Screening

    Measured: 12 weeks

  10. Homocysteine

    Week 12 vs. Screening

    Measured: 12 weeks

  11. Pulse wave assessment

    Week 12 vs. week 0

    Measured: 12 weeks

  12. Metabolome analysis

    Week 12 vs. week 0

    Measured: 12 weeks

  13. SF-12

    Week 4, week 9 and week 12 vs. week 0, respectively

    Measured: 12 weeks

  14. Global evaluation of benefit by the subjects/ investigator

    Week 12 only

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2016 (estimated)
  2. Study start17 Mar 2017
  3. Primary completion30 Jan 2018
  4. Study completion30 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02871362
Sponsor's protocol ID
INQ/030915
Status last verified
Feb 2019
First submitted
10 Aug 2016
Last updated
4 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing IQP-AS-118 in people with Blood Pressure and Low Density Lipoprotein Cholesterol Level, run by InQpharm Group at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (Systolic & Diastolic) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02871362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.

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