PrehypertensionPhase 2NCT01974570
Effect and Safety of Marealis RPC (Refined Peptide Concentrate) in Mild or Moderate Hypertensive Subjects
A Phase 2 study testing Marealis refined peptide concentrate in people with Prehypertension, run by KGK Science Inc. at 13 sites in 4 countries.
Trial summary
Hypertension is an important risk factor of cardiovascular (CVD) and renal diseases. Epidemiological studies show that there is a direct relationship between blood pressure and CVD, and cardiovascular mortality increases progressively throughout the range of blood pressure, including the prehypertensive range. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension
- What is being tested?
- Marealis refined peptide concentrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Nov 2013to Nov 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 30 to 75 years inclusive (independent and home-living subject).
- If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation); OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- Mild or moderate hypertension (SBP 140-160 mmHg and DBP ≤ 100mmHg) (mean of office blood pressure measurements at the two first study visits during run-in period (visits 1 (-4 week) and 2 (-2 week)). Average office SBP baseline to be as close to 150mm Hg (i.e. 147-149 mmHg) as possible.
- Body weight ≥60kg
- Stable body weight (self-reported weight gain or loss <5kg in the past three months)
- Has given voluntary, written, informed consent to participate in the study
- Agrees to comply with study procedures including willingness to fast at least 12 hours before blood samples and abstain from alcohol two days prior to blood sampling and blood pressure measurement and abstain from coffee at least 14 hours before blood pressure measurement and abstain from physical exercise at least 4 hours before blood pressure measurement
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Body mass index ≥ 35 kg/m2
- Antihypertensive drug treatment, regular high dose NSAID treatment, use of cyclosporine or tacrolimus
- Any history of cardiovascular disease (myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attack) including stroke and congestive heart failure
- Dementia, hypertensive retinopathy, left ventricular dysfunction or peripheral artery disease
- Anemia, abnormal electrolytes, proteinuria, abnormal liver, kidney and thyroid function (except subjects on thyroid replacement therapy)
Show all 18Show fewer
- Clinically significant laboratory results
- Any other clinically significant abnormality in hematology and/or biochemistry at the Investigator's discretion
- Secondary hypertension
- Diabetes (type 1 and type 2 diabetes)
- History of cancer or malignant disease within the past 5 years(excluding basal cell carcinoma)
- 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 subject
- Dietary restriction (fish and other seafood allergies, citrus allergies, multiple food allergies)
- Alcohol abuse and/or illicit drug consumption; subjects consuming more than 14 portions of alcohol per week (one portion = 1 oz. spirits or 4 oz. wine or 11oz. medium strength beer / cider) Smokers and tobacco/snuff/nicotine users
- Consumption of natural health products targeted to blood pressure lowering within 30 days before randomization and during the study
- Participation in a clinical research trial within 30 days prior to randomization or during the study
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Canada10 sites
Dr. William O'Mahony Medicine Professional Corporation
Corunna, Ontario, N0N 1G0
Dr. Steven V. Zizzo Medicine Professional Corporation
Hamilton, Ontario, L8J 0B6
Milestone Research
London, Ontario, N5W 6A2
Schacter Medicine Professional Corporation
London, Ontario, N5Y 5K7
KGK Synergize Inc.
London, Ontario, N6A 5R8
Dr. Dorli Herman
London, Ontario, N6J 0A8
SKDS Research Inc.
Newmarket, Ontario, L3Y 5G8
Glencar Medical Inc.
Sarnia, Ontario, N7T 4X3
Dr. Anil Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4
Devonshire Clinical Research
Woodstock, Ontario, N4S 5P5
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Study for the Assessment of Anti-hypertensive Effect and Safety of Marealis RPC (Refined Peptide Concentrate), in Healthy Subjects With Mild or Moderate Hypertension
Hypertension is an important risk factor of cardiovascular (CVD) and renal diseases. Epidemiological studies show that there is a direct relationship between blood pressure and CVD, and cardiovascular mortality increases progressively throughout the range of blood pressure, including the prehypertensive range. There is also evidence from cell and animal studies that shrimp tissue hydrolysates may have higher ACE inhibitory activity than other marine protein hydrolysates. It is hypothesized that Marealis RPC (refined peptide concentrate)will lower systolic blood pressure in subjects with elevated blood pressure.
- Conditions
- Prehypertension
- Being tested
- Marealis refined peptide concentrate, Placebo
- Keywords
- Prehypertension, Hypertension, Shrimp protein hydrolysate, Marine protein hydrolysate, Ambulatory blood pressure, Blood pressure
- Medical subject headings
- Prehypertension, 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
2 tablets, once per day before noon
PlaceboDietary supplement
2 tablets, once per day before noon
| Study group | Role | What they receive |
|---|---|---|
| Marealis refined peptide concentrate | Experimental | Participants are provided in double blinded fashion to Marealis refined peptide concentrate Receives: Dietary Supplement: Marealis refined peptide concentrate |
| Placebo | Placebo comparator | Participants are provided in double blinded fashion to Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daytime ambulatory systolic blood pressure from baseline
Measured: 8 weeks
Change in office systolic blood pressure from baseline
Measured: 8 weeks
Secondary outcomes (10)
Change in 24-hour and nighttime ambulatory systolic blood pressure from baseline
Measured: 8 weeks
Change in 24-hour, daytime and nighttime ambulatory diastolic blood pressure from baseline
Measured: 8 weeks
Changes in 24-hour, daytime and nighttime ambulatory systolic and ambulatory diastolic blood pressure from baseline
Measured: 4 weeks
Mean ambulatory systolic blood pressure (24-hour, daytime and nighttime)
Measured: Over 8 weeks
Mean ambulatory diastolic blood pressure (24-hour, daytime and nighttime)
Measured: Over 8 weeks
Change in office diastolic blood pressure from baseline
Measured: 8 weeks
Changes in office systolic and office diastolic blood pressure from baseline
Measured: 2 weeks
Changes in office systolic and office diastolic blood pressure from baseline
Measured: 4 weeks
Mean Office systolic blood pressure
Measured: Over 8 weeks
Mean Office diastolic blood pressure
Measured: Over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrehypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Marealis AS
- Responsible party
- Sponsor
- Investigators
- Dale Wilson, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974570
- Sponsor's protocol ID
- 13TBHM
- Status last verified
- Dec 2015
- First submitted
- 28 Oct 2013
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Musa-Veloso K, Paulionis L, Pelipyagina T, Evans M. A Randomized, Double-Blind, Placebo-Controlled, Multicentre Trial of the Effects of a Shrimp Protein Hydrolysate on Blood Pressure. Int J Hypertens. 2019 Aug 5;2019:2345042. doi: 10.1155/2019/2345042. eCollection 2019.
PubMed 31467699
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Parallel Study for the Assessment of Anti-hypertensive Effect and Safety of Marealis RPC (Refined Peptide Concentrate), in Healthy Subjects With Mild or Moderate Hypertension
- ClinicalTrials.gov ID
- NCT01974570
- Acronym / sponsor ID
- 13TBHM
- Conditions
- Prehypertension
- Keywords
- Prehypertension, Hypertension, Shrimp protein hydrolysate, Marine protein hydrolysate, Ambulatory blood pressure, Blood pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- Marealis AS
- Study start
- Nov 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Nov 2013 (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.
Hypertension is an important risk factor of cardiovascular (CVD) and renal diseases. Epidemiological studies show that there is a direct relationship between blood pressure and CVD, and cardiovascular mortality increases progressively throughout the range of blood pressure, including the prehypertensive range. There is also evidence from cell and animal studies that shrimp tissue hydrolysates may have higher ACE inhibitory activity than other marine protein hydrolysates. It is hypothesized that Marealis RPC (refined peptide concentrate)will lower systolic blood pressure in subjects with elevated blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marealis refined peptide concentrate | Experimental | Dietary Supplement: Marealis refined peptide concentrateParticipants are provided in double blinded fashion to Marealis refined peptide concentrate |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants are provided in double blinded fashion to Placebo |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged 30 to 75 years inclusive (independent and home-living subject).
- If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation); OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- Mild or moderate hypertension (SBP 140-160 mmHg and DBP ≤ 100mmHg) (mean of office blood pressure measurements at the two first study visits during run-in period (visits 1 (-4 week) and 2 (-2 week)). Average office SBP baseline to be as close to 150mm Hg (i.e. 147-149 mmHg) as possible.
- Body weight ≥60kg
- Stable body weight (self-reported weight gain or loss <5kg in the past three months)
Key exclusion criteria (18 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Body mass index ≥ 35 kg/m2
- Antihypertensive drug treatment, regular high dose NSAID treatment, use of cyclosporine or tacrolimus
- Any history of cardiovascular disease (myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attack) including stroke and congestive heart failure
- Dementia, hypertensive retinopathy, left ventricular dysfunction or peripheral artery disease
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 concentrate2 tablets, once per day before noon | Dietary supplement | Marealis refined peptide concentrate |
| Placebo2 tablets, once per day before noon | Dietary supplement | Placebo |
Primary outcome
Change in daytime ambulatory systolic blood pressure from baseline
Time frame: 8 weeks
Change in office systolic blood pressure from baseline
Time frame: 8 weeks
10 secondary outcomes
Change in 24-hour and nighttime ambulatory systolic blood pressure from baseline
Time frame: 8 weeks
Change in 24-hour, daytime and nighttime ambulatory diastolic blood pressure from baseline
Time frame: 8 weeks
Changes in 24-hour, daytime and nighttime ambulatory systolic and ambulatory diastolic blood pressure from baseline
Time frame: 4 weeks
Mean ambulatory systolic blood pressure (24-hour, daytime and nighttime)
Time frame: Over 8 weeks
Mean ambulatory diastolic blood pressure (24-hour, daytime and nighttime)
Time frame: Over 8 weeks
Change in office diastolic blood pressure from baseline
Time frame: 8 weeks
Changes in office systolic and office diastolic blood pressure from baseline
Time frame: 2 weeks
Changes in office systolic and office diastolic blood pressure from baseline
Time frame: 4 weeks
Mean Office systolic blood pressure
Time frame: Over 8 weeks
Mean Office diastolic blood pressure
Time frame: Over 8 weeks
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 24 Dec 2015.
- Derived from this study: PubMed 31467699Musa-Veloso K, Paulionis L, Pelipyagina T, Evans M. A Randomized, Double-Blind, Placebo-Controlled, Multicentre Trial of the Effects of a Shrimp Protein Hydrolysate on Blood Pressure. Int J Hypertens. 2019 Aug 5;2019:2345042. doi: 10.1155/2019/2345042. eCollection 2019.
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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.
Dale Wilson, MD principal investigator
KGK Science Inc.
13 sites in 4 countries: 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 Prehypertension, run by KGK Science Inc. at 13 sites in 4 countries.
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 7 inclusion and 18 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 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, United States, Czechia, 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.
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 daytime ambulatory systolic blood pressure from baseline (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT01974570, which also lists 1 linked publication.
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 24 Dec 2015.