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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refined peptide concentrate, 1200 mg | Experimental | Refined peptide concentrate, 1 200 mg, once a day |
|
| Refined peptide concentrate, 2 x 600 mg | Experimental | Refined peptide concentrate, 600 mg, twice a day |
|
| Refined peptide concentrate, 0 mg | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marealis Refined Peptide Concentrate | Dietary Supplement | 1200 mg per os, once a day, 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in diastolic blood pressure | change from baseline after 8 weeks of treatment in diastolic blood pressure | from baseline after 8 weeks of treatment |
| mean systolic blood pressure | at the end of a 8-week treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Essi S Sarkkinen, Ph.D | Oy Foodfiles Ltd | Study Director |
| Sakari A Nieminen, MD | Oy Foodfiles Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oy Foodfiles Ltd | Kuopio | 70210 | Finland |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Marealis Refined Peptide Concentrate | Dietary Supplement | 600 mg per os, twice a day, 8 weeks |
|
| Marealis Refined Peptide Concentrate | Dietary Supplement | 0 mg per os, daily, 8 weeks |
|
| 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 |
| diastolic blood pressure | from baseline after 2 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 | plasma total cholesterol, HDL-cholesterol, LDL-cholesterol and total triglycerides concentration, respectively | at the end of a 8 week treatment |
| mean serum C-reactive protein | at the end of a 8-week treatment |
| 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 |
| change in systolic blood pressure | from the baseline after 2 weeks treatment |