NCT01583582

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

9 months

First QC Date

April 20, 2012

Last Update Submit

January 30, 2013

Conditions

HypertensionBlood Pressure

Keywords

randomized double-blind placebo-controlled studypeptide concentrateColdwater Shrimpantihypertensive effectmild hypertensionmoderate hypertensionblood pressure

Outcome Measures

Primary Outcomes (1)

  • change in systolic blood pressure

    change from baseline after 8 weeks of treatment in systolic office blood pressure

    from baseline after 8 weeks of treatment

Secondary Outcomes (17)

  • change in diastolic blood pressure

    from baseline after 8 weeks of treatment

  • mean systolic blood pressure

    at the end of a 8-week treatment

  • mean diastolic blood pressure

    at the end of a 8-week treatment

  • change in systolic blood pressure

    from baseline after 4 weeks treatment

  • diastolic blood pressure

    from baseline after 4 weeks treatment

  • +12 more secondary outcomes

Study Arms (3)

Refined peptide concentrate, 1200 mg

EXPERIMENTAL

Refined peptide concentrate, 1 200 mg, once a day

Dietary Supplement: Marealis Refined Peptide Concentrate

Refined peptide concentrate, 2 x 600 mg

EXPERIMENTAL

Refined peptide concentrate, 600 mg, twice a day

Dietary Supplement: Marealis Refined Peptide Concentrate

Refined peptide concentrate, 0 mg

PLACEBO COMPARATOR
Dietary Supplement: Marealis Refined Peptide Concentrate

Interventions

Marealis Refined Peptide ConcentrateDIETARY_SUPPLEMENT

1200 mg per os, once a day, 8 weeks

Refined peptide concentrate, 1200 mg

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oy Foodfiles Ltd

Kuopio, 70210, Finland

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Essi S Sarkkinen, Ph.D

    Oy Foodfiles Ltd

    STUDY DIRECTOR

  • Sakari A Nieminen, MD

    Oy Foodfiles Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 24, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

FI(1)