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

30. januar 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

74

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Finland
      • Kuopio, Finland, 70210
        • Oy Foodfiles Ltd

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Refined peptide concentrate, 1200 mg
Refined peptide concentrate, 1 200 mg, once a day
Kosttilskud: Marealis Refined Peptide Concentrate
1200 mg per os, once a day, 8 weeks
Kosttilskud: Marealis Refined Peptide Concentrate
600 mg per os, twice a day, 8 weeks
Kosttilskud: Marealis Refined Peptide Concentrate
0 mg per os, daily, 8 weeks
Eksperimentel: Refined peptide concentrate, 2 x 600 mg
Refined peptide concentrate, 600 mg, twice a day
Kosttilskud: Marealis Refined Peptide Concentrate
1200 mg per os, once a day, 8 weeks
Kosttilskud: Marealis Refined Peptide Concentrate
600 mg per os, twice a day, 8 weeks
Kosttilskud: Marealis Refined Peptide Concentrate
0 mg per os, daily, 8 weeks
Placebo komparator: Refined peptide concentrate, 0 mg
Kosttilskud: Marealis Refined Peptide Concentrate
1200 mg per os, once a day, 8 weeks
Kosttilskud: Marealis Refined Peptide Concentrate
600 mg per os, twice a day, 8 weeks
Kosttilskud: Marealis Refined Peptide Concentrate
0 mg per os, daily, 8 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Marealis AS

Efterforskere

  • Studieleder: Essi S Sarkkinen, Ph.D, Oy Foodfiles Ltd
  • Ledende efterforsker: Sakari A Nieminen, MD, Oy Foodfiles Ltd

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2012

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

20. april 2012

Først indsendt, der opfyldte QC-kriterier

20. april 2012

Først opslået (Skøn)

24. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MARE-050312

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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