Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp (MARE)

Marealis

Status and phase: Completed; Phase 2

Conditions: Hypertension; Blood Pressure

Treatments: Dietary Supplement: Marealis Refined Peptide Concentrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01583582

MARE-050312

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

74 participants in 3 patient groups, including a placebo group

Refined peptide concentrate, 1200 mg

Experimental group

Description:

Refined peptide concentrate, 1 200 mg, once a day

Treatment:

Dietary Supplement: Marealis Refined Peptide Concentrate

Dietary Supplement: Marealis Refined Peptide Concentrate

Dietary Supplement: Marealis Refined Peptide Concentrate

Refined peptide concentrate, 2 x 600 mg

Experimental group

Description:

Refined peptide concentrate, 600 mg, twice a day

Treatment:

Dietary Supplement: Marealis Refined Peptide Concentrate

Dietary Supplement: Marealis Refined Peptide Concentrate

Dietary Supplement: Marealis Refined Peptide Concentrate

Refined peptide concentrate, 0 mg

Placebo Comparator group

Treatment:

Dietary Supplement: Marealis Refined Peptide Concentrate

Dietary Supplement: Marealis Refined Peptide Concentrate

Dietary Supplement: Marealis Refined Peptide Concentrate