HypertensionPhase 2MARENCT01583582
Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp
A Phase 2 study testing Marealis Refined Peptide Concentrate in people with Hypertension and Blood Pressure, run by Marealis AS at 1 site in Finland.
Trial summary
The purpose of this proof of concept study is to find out the efficacy of Marealis Refined Peptide Concentrate (RPC) from Coldwater Shrimp (Pandalus borealis) containing ACE-inhibiting peptides on blood pressure in subjects with mild or moderate hypertension. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hypertension, Blood Pressure
- What is being tested?
- Marealis Refined Peptide Concentrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2012to Dec 2012
- Phase
- Phase 2
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild or moderate hypertension (systolic blood pressure 130 - 160 mmHg and diastolic blood pressure ≤ 100 mmHg)
- age 30 - 75 years
- body weight ≥ 60 kg
- stable body weight
- use of effective contraception in women of childbearing potential
Who cannot join
- body mass index ≥ 35
- antihypertensive drug treatment, regular high dose NSAID treatment and the use of cyclosporine or tacrolimus
- diabetes (type 1 and 2)
- anemia, abnormal electrolytes, proteinuria, abnormal liver, kidney and thyroid function, clinically significant biochemistry, any other clinically significant hematology and/or biochemistry at the investigator's discretion
- cardiovascular disease (myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attack within six months prior to screening) including stroke and congestive heart failure
- secondary hypertension history of cancer or malignant disease within the past five years
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- any 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 subjects
- fish and other seafood allergies, citrus allergy, multiple food allergies
- alcohol abuse
- smokers and tobacco/snuff/nicotine users
- consumption of food supplements targeted to blood pressure lowering within 30 days before randomization
- pregnant and lactating mothers, women, planning for pregnancy during the study
- participation in clinical trials 30 days prior to this study and participation in other clinical intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment on Antihypertensive Effect and Safety of Bioactive Peptides Derived From Coldwater Shrimp (Pandalus Borealis) in Healthy Subjects With Mild or Moderate Hypertension
The purpose of this proof of concept study is to find out the efficacy of Marealis Refined Peptide Concentrate (RPC) from Coldwater Shrimp (Pandalus borealis) containing ACE-inhibiting peptides on blood pressure in subjects with mild or moderate hypertension.
- Conditions
- Hypertension, Blood Pressure
- Being tested
- Marealis Refined Peptide Concentrate
- Keywords
- randomized double-blind placebo-controlled study, peptide concentrate, Coldwater Shrimp, antihypertensive effect, mild hypertension, moderate hypertension, blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marealis Refined Peptide ConcentrateDietary supplement
1200 mg per os, once a day, 8 weeks
Marealis Refined Peptide ConcentrateDietary supplement
600 mg per os, twice a day, 8 weeks
Marealis Refined Peptide ConcentrateDietary supplement
0 mg per os, daily, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Refined peptide concentrate, 1200 mg | Experimental | Refined peptide concentrate, 1 200 mg, once a day Receives: Dietary Supplement: Marealis Refined Peptide Concentrate |
| Refined peptide concentrate, 2 x 600 mg | Experimental | Refined peptide concentrate, 600 mg, twice a day Receives: Dietary Supplement: Marealis Refined Peptide Concentrate |
| Refined peptide concentrate, 0 mg | Placebo comparator | Not described Receives: Dietary Supplement: Marealis Refined Peptide Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in systolic blood pressure
change from baseline after 8 weeks of treatment in systolic office blood pressure
Measured: from baseline after 8 weeks of treatment
Secondary outcomes (17)
change in diastolic blood pressure
change from baseline after 8 weeks of treatment in diastolic blood pressure
Measured: from baseline after 8 weeks of treatment
mean systolic blood pressure
Measured: at the end of a 8-week treatment
mean diastolic blood pressure
Measured: at the end of a 8-week treatment
change in systolic blood pressure
Measured: from baseline after 4 weeks treatment
diastolic blood pressure
Measured: from baseline after 4 weeks treatment
diastolic blood pressure
Measured: from baseline after 2 weeks treatment
mean heart rate
Measured: at the end of a 8-week treatment
mean fasting plasma glucose concentration
Measured: at the end of a 8-week treatment
mean fasting plasma lipids concentration
plasma total cholesterol, HDL-cholesterol, LDL-cholesterol and total triglycerides concentration, respectively
Measured: at the end of a 8 week treatment
mean serum C-reactive protein
Measured: at the end of a 8-week treatment
blood count
Measured: at the end of a 8-week treatment
plasma glutamyltransferase
Measured: at the end of a 8-week treatment
plasma creatinine
Measured: at the end of a 8-week treatment
plasma sodium concentration
Measured: at the end of a 8-week treatment
plasma potassium concentration
Measured: at the end of a 8-week treatment
adverse events
Measured: during the 8-week treatment
change in systolic blood pressure
Measured: from the baseline after 2 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marealis AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Niina Tapola, Marealis AS
- Investigators
- Essi S Sarkkinen, Ph.D, Study director, Oy Foodfiles LtdSakari A Nieminen, MD, Principal investigator, Oy Foodfiles Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583582
- Sponsor's protocol ID
- MARE-050312
- Acronym
- MARE
- Status last verified
- Jan 2013
- First submitted
- 20 Apr 2012
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment on Antihypertensive Effect and Safety of Bioactive Peptides Derived From Coldwater Shrimp (Pandalus Borealis) in Healthy Subjects With Mild or Moderate Hypertension
- ClinicalTrials.gov ID
- NCT01583582
- Acronym / sponsor ID
- MARE / MARE-050312
- Conditions
- Hypertension, Blood Pressure
- Keywords
- randomized double-blind placebo-controlled study, peptide concentrate, Coldwater Shrimp, antihypertensive effect, mild hypertension, moderate hypertension, blood pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Marealis ASIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this proof of concept study is to find out the efficacy of Marealis Refined Peptide Concentrate (RPC) from Coldwater Shrimp (Pandalus borealis) containing ACE-inhibiting peptides on blood pressure in subjects with mild or moderate hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Refined peptide concentrate, 1200 mg | Experimental | Dietary Supplement: Marealis Refined Peptide ConcentrateRefined peptide concentrate, 1 200 mg, once a day |
| Refined peptide concentrate, 2 x 600 mg | Experimental | Dietary Supplement: Marealis Refined Peptide ConcentrateRefined peptide concentrate, 600 mg, twice a day |
| Refined peptide concentrate, 0 mg | Placebo comparator | Dietary Supplement: Marealis Refined Peptide Concentrate |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- mild or moderate hypertension (systolic blood pressure 130 - 160 mmHg and diastolic blood pressure ≤ 100 mmHg)
- age 30 - 75 years
- body weight ≥ 60 kg
- stable body weight
- use of effective contraception in women of childbearing potential
Key exclusion criteria (13 listed)
- body mass index ≥ 35
- antihypertensive drug treatment, regular high dose NSAID treatment and the use of cyclosporine or tacrolimus
- diabetes (type 1 and 2)
- anemia, abnormal electrolytes, proteinuria, abnormal liver, kidney and thyroid function, clinically significant biochemistry, any other clinically significant hematology and/or biochemistry at the investigator's discretion
- cardiovascular disease (myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attack within six months prior to screening) including stroke and congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marealis Refined Peptide Concentrate1200 mg per os, once a day, 8 weeks | Dietary supplement | Refined peptide concentrate, 1200 mg |
| Marealis Refined Peptide Concentrate600 mg per os, twice a day, 8 weeks | Dietary supplement | Refined peptide concentrate, 2 x 600 mg |
| Marealis Refined Peptide Concentrate0 mg per os, daily, 8 weeks | Dietary supplement | Refined peptide concentrate, 0 mg |
Primary outcome
change in systolic blood pressure
Time frame: from baseline after 8 weeks of treatment
change from baseline after 8 weeks of treatment in systolic office blood pressure
17 secondary outcomes
change in diastolic blood pressure
Time frame: from baseline after 8 weeks of treatment
mean systolic blood pressure
Time frame: at the end of a 8-week treatment
mean diastolic blood pressure
Time frame: at the end of a 8-week treatment
change in systolic blood pressure
Time frame: from baseline after 4 weeks treatment
diastolic blood pressure
Time frame: from baseline after 4 weeks treatment
diastolic blood pressure
Time frame: from baseline after 2 weeks treatment
mean heart rate
Time frame: at the end of a 8-week treatment
mean fasting plasma glucose concentration
Time frame: at the end of a 8-week treatment
mean fasting plasma lipids concentration
Time frame: at the end of a 8 week treatment
mean serum C-reactive protein
Time frame: at the end of a 8-week treatment
blood count
Time frame: at the end of a 8-week treatment
plasma glutamyltransferase
Time frame: at the end of a 8-week treatment
plasma creatinine
Time frame: at the end of a 8-week treatment
plasma sodium concentration
Time frame: at the end of a 8-week treatment
plasma potassium concentration
Time frame: at the end of a 8-week treatment
adverse events
Time frame: during the 8-week treatment
change in systolic blood pressure
Time frame: from the baseline after 2 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Essi S Sarkkinen, Ph.D study director
Oy Foodfiles Ltd
Sakari A Nieminen, MD principal investigator
Oy Foodfiles Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Marealis Refined Peptide Concentrate in people with Hypertension and Blood Pressure, run by Marealis AS at 1 site in Finland.
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 5 inclusion and 13 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 31 Jan 2013. 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 Finland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in systolic blood pressure (time frame: from baseline after 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2013.