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NCT01583582

Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp

NCT ID: NCT01583582

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Blood Pressure

Keywords

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randomized double-blind placebo-controlled study peptide concentrate Coldwater Shrimp antihypertensive effect mild hypertension moderate hypertension blood pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Refined peptide concentrate, 1200 mg

Refined peptide concentrate, 1 200 mg, once a day

Group Type EXPERIMENTAL

Marealis Refined Peptide Concentrate

Intervention Type DIETARY_SUPPLEMENT

1200 mg per os, once a day, 8 weeks

Refined peptide concentrate, 2 x 600 mg

Refined peptide concentrate, 600 mg, twice a day

Group Type EXPERIMENTAL

Marealis Refined Peptide Concentrate

Intervention Type DIETARY_SUPPLEMENT

600 mg per os, twice a day, 8 weeks

Refined peptide concentrate, 0 mg

Group Type PLACEBO_COMPARATOR

Marealis Refined Peptide Concentrate

Intervention Type DIETARY_SUPPLEMENT

0 mg per os, daily, 8 weeks

Interventions

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Marealis Refined Peptide Concentrate

1200 mg per os, once a day, 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Marealis Refined Peptide Concentrate

600 mg per os, twice a day, 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Marealis Refined Peptide Concentrate

0 mg per os, daily, 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marealis AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Niina Tapola

Project Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Essi S Sarkkinen, Ph.D

Role: STUDY_DIRECTOR

Oy Foodfiles Ltd

Sakari A Nieminen, MD

Role: PRINCIPAL_INVESTIGATOR

Oy Foodfiles Ltd

Locations

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Oy Foodfiles Ltd

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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MARE-050312

Identifier Type: -

Identifier Source: org_study_id