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| Name | Class |
|---|---|
| Marealis AS | INDUSTRY |
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Hypertension is an important risk factor of cardiovascular (CVD) and renal diseases. Epidemiological studies show that there is a direct relationship between blood pressure and CVD, and cardiovascular mortality increases progressively throughout the range of blood pressure, including the prehypertensive range. There is also evidence from cell and animal studies that shrimp tissue hydrolysates may have higher ACE inhibitory activity than other marine protein hydrolysates. It is hypothesized that Marealis RPC (refined peptide concentrate)will lower systolic blood pressure in subjects with elevated blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marealis refined peptide concentrate | Experimental | Participants are provided in double blinded fashion to Marealis refined peptide concentrate |
|
| Placebo | Placebo Comparator | Participants are provided in double blinded fashion to Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marealis refined peptide concentrate | Dietary Supplement | 2 tablets, once per day before noon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in daytime ambulatory systolic blood pressure from baseline | 8 weeks | |
| Change in office systolic blood pressure from baseline | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour and nighttime ambulatory systolic blood pressure from baseline | 8 weeks | |
| Change in 24-hour, daytime and nighttime ambulatory diastolic blood pressure from baseline | 8 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Mean heart rate | Over 8 weeks | |
| Mean fasting serum glucose | 8 weeks | |
| Mean fasting serum lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, total triglycerides) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale Wilson, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Inc. | Addison | Illinois | 60101 | United States | ||
| Dr. William O'Mahony Medicine Professional Corporation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31467699 | Derived | Musa-Veloso K, Paulionis L, Pelipyagina T, Evans M. A Randomized, Double-Blind, Placebo-Controlled, Multicentre Trial of the Effects of a Shrimp Protein Hydrolysate on Blood Pressure. Int J Hypertens. 2019 Aug 5;2019:2345042. doi: 10.1155/2019/2345042. eCollection 2019. |
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| Placebo | Dietary Supplement | 2 tablets, once per day before noon |
|
| Changes in 24-hour, daytime and nighttime ambulatory systolic and ambulatory diastolic blood pressure from baseline |
| 4 weeks |
| Mean ambulatory systolic blood pressure (24-hour, daytime and nighttime) | Over 8 weeks |
| Mean ambulatory diastolic blood pressure (24-hour, daytime and nighttime) | Over 8 weeks |
| Change in office diastolic blood pressure from baseline | 8 weeks |
| Changes in office systolic and office diastolic blood pressure from baseline | 2 weeks |
| Changes in office systolic and office diastolic blood pressure from baseline | 4 weeks |
| Mean Office systolic blood pressure | Over 8 weeks |
| Mean Office diastolic blood pressure | Over 8 weeks |
| 8 weeks |
| Mean serum C-reactive protein | 8 weeks |
| Dietary variables from food records (energy, carbohydrates, fats, proteins, fiber and sodium) | Over 8 weeks |
| Mean urine sodium | 8 weeks |
| Biometrics: weight and BMI | 8 weeks |
| Blood safety parameters: complete blood count, electrolytes (Na, K, Cl), creatinine, eGFR, AST, ALT, GGT, bilirubin | 8 weeks |
| Adverse events | Over 8 weeks |
| Corunna |
| Ontario |
| N0N 1G0 |
| Canada |
| Dr. Steven V. Zizzo Medicine Professional Corporation | Hamilton | Ontario | L8J 0B6 | Canada |
| Milestone Research | London | Ontario | N5W 6A2 | Canada |
| Schacter Medicine Professional Corporation | London | Ontario | N5Y 5K7 | Canada |
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
| Dr. Dorli Herman | London | Ontario | N6J 0A8 | Canada |
| SKDS Research Inc. | Newmarket | Ontario | L3Y 5G8 | Canada |
| Glencar Medical Inc. | Sarnia | Ontario | N7T 4X3 | Canada |
| Dr. Anil Gupta Medicine Professional Corporation | Toronto | Ontario | M9V 4B4 | Canada |
| Devonshire Clinical Research | Woodstock | Ontario | N4S 5P5 | Canada |
| A-Pharma, s.r.o | Prague | Czechia |
| Analyze and Realize GmBH Professional Group | Berlin | Germany |
| ID | Term |
|---|---|
| D058246 | Prehypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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