Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp (MARE)
30. januar 2013 oppdatert av: Niina Tapola, Marealis AS
Assessment on Antihypertensive Effect and Safety of Bioactive Peptides Derived From Coldwater Shrimp (Pandalus Borealis) in Healthy Subjects With Mild or Moderate Hypertension
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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
74
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Kuopio, Finland, 70210
- Oy Foodfiles Ltd
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Refined peptide concentrate, 1200 mg
Refined peptide concentrate, 1 200 mg, once a day
|
1200 mg per os, once a day, 8 weeks
600 mg per os, twice a day, 8 weeks
0 mg per os, daily, 8 weeks
|
|
Eksperimentell: Refined peptide concentrate, 2 x 600 mg
Refined peptide concentrate, 600 mg, twice a day
|
1200 mg per os, once a day, 8 weeks
600 mg per os, twice a day, 8 weeks
0 mg per os, daily, 8 weeks
|
|
Placebo komparator: Refined peptide concentrate, 0 mg
|
1200 mg per os, once a day, 8 weeks
600 mg per os, twice a day, 8 weeks
0 mg per os, daily, 8 weeks
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
change in systolic blood pressure
Tidsramme: from baseline after 8 weeks of treatment
|
change from baseline after 8 weeks of treatment in systolic office blood pressure
|
from baseline after 8 weeks of treatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
change in diastolic blood pressure
Tidsramme: from baseline after 8 weeks of treatment
|
change from baseline after 8 weeks of treatment in diastolic blood pressure
|
from baseline after 8 weeks of treatment
|
|
mean systolic blood pressure
Tidsramme: at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
|
mean diastolic blood pressure
Tidsramme: at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
|
change in systolic blood pressure
Tidsramme: from baseline after 4 weeks treatment
|
from baseline after 4 weeks treatment
|
|
|
diastolic blood pressure
Tidsramme: from baseline after 4 weeks treatment
|
from baseline after 4 weeks treatment
|
|
|
diastolic blood pressure
Tidsramme: from baseline after 2 weeks treatment
|
from baseline after 2 weeks treatment
|
|
|
mean heart rate
Tidsramme: at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
|
mean fasting plasma glucose concentration
Tidsramme: at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
|
mean fasting plasma lipids concentration
Tidsramme: at the end of a 8 week treatment
|
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
Tidsramme: at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
|
blood count
Tidsramme: at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
|
plasma glutamyltransferase
Tidsramme: at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
|
plasma creatinine
Tidsramme: at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
|
plasma sodium concentration
Tidsramme: at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
|
plasma potassium concentration
Tidsramme: at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
|
adverse events
Tidsramme: during the 8-week treatment
|
during the 8-week treatment
|
|
|
change in systolic blood pressure
Tidsramme: from the baseline after 2 weeks treatment
|
from the baseline after 2 weeks treatment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Essi S Sarkkinen, Ph.D, Oy Foodfiles Ltd
- Hovedetterforsker: Sakari A Nieminen, MD, Oy Foodfiles Ltd
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2012
Primær fullføring (Faktiske)
1. desember 2012
Studiet fullført (Faktiske)
1. desember 2012
Datoer for studieregistrering
Først innsendt
20. april 2012
Først innsendt som oppfylte QC-kriteriene
20. april 2012
Først lagt ut (Anslag)
24. april 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
31. januar 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. januar 2013
Sist bekreftet
1. januar 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MARE-050312
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .