Clinical trial NCT01583582: Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Blood Pressure
Keywords: randomized double-blind placebo-controlled study
peptide concentrate
Coldwater Shrimp
antihypertensive effect
mild hypertension
moderate hypertension
blood pressure
Lead sponsor: Marealis AS
Sponsor class: INDUSTRY
First posted: 2012-04-24
Enrollment: 74
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in systolic blood pressure
timeFrame: from baseline after 8 weeks of treatment
Secondary outcomes:
measure: change in diastolic blood pressure
timeFrame: from baseline after 8 weeks of treatment
measure: mean systolic blood pressure
timeFrame: at the end of a 8-week treatment
measure: mean diastolic blood pressure
timeFrame: at the end of a 8-week treatment
measure: change in systolic blood pressure
timeFrame: from baseline after 4 weeks treatment
measure: diastolic blood pressure
timeFrame: from baseline after 4 weeks treatment
measure: diastolic blood pressure
timeFrame: from baseline after 2 weeks treatment
measure: mean heart rate
timeFrame: at the end of a 8-week treatment
measure: mean fasting plasma glucose concentration
timeFrame: at the end of a 8-week treatment
measure: mean fasting plasma lipids concentration
timeFrame: at the end of a 8 week treatment
measure: mean serum C-reactive protein
timeFrame: at the end of a 8-week treatment
measure: blood count
timeFrame: at the end of a 8-week treatment
measure: plasma glutamyltransferase
timeFrame: at the end of a 8-week treatment
measure: plasma creatinine
timeFrame: at the end of a 8-week treatment
measure: plasma sodium concentration
timeFrame: at the end of a 8-week treatment
measure: plasma potassium concentration
timeFrame: at the end of a 8-week treatment
measure: adverse events
timeFrame: during the 8-week treatment
measure: change in systolic blood pressure
timeFrame: from the baseline after 2 weeks treatment
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Oy Foodfiles Ltd
Study officials:
affiliation: Oy Foodfiles Ltd
name: Essi S Sarkkinen, Ph.D
role: STUDY_DIRECTOR
affiliation: Oy Foodfiles Ltd
name: Sakari A Nieminen, MD
role: PRINCIPAL_INVESTIGATOR
References: