Blood Pressure, Hypertension
Conditions
Keywords
randomized double-blind placebo-controlled study, peptide concentrate, Coldwater Shrimp, antihypertensive effect, mild hypertension, moderate hypertension, blood pressure
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.
Interventions
DIETARY_SUPPLEMENTMarealis Refined Peptide Concentrate
1200 mg per os, once a day, 8 weeks
Sponsors
Marealis AS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in systolic blood pressure | from baseline after 8 weeks of treatment | change from baseline after 8 weeks of treatment in systolic office blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| mean heart rate | at the end of a 8-week treatment | — |
| mean fasting plasma glucose concentration | at the end of a 8-week treatment | — |
| mean fasting plasma lipids concentration | at the end of a 8 week treatment | plasma total cholesterol, HDL-cholesterol, LDL-cholesterol and total triglycerides concentration, respectively |
| change in diastolic blood pressure | from baseline after 8 weeks of treatment | change from baseline after 8 weeks of treatment in diastolic blood pressure |
| blood count | at the end of a 8-week treatment | — |
| plasma glutamyltransferase | at the end of a 8-week treatment | — |
| plasma creatinine | at the end of a 8-week treatment | — |
| plasma sodium concentration | at the end of a 8-week treatment | — |
| plasma potassium concentration | at the end of a 8-week treatment | — |
| adverse events | during the 8-week treatment | — |
| mean serum C-reactive protein | at the end of a 8-week treatment | — |
Countries
Finland
Outcome results
None listed