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Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults

4. december 2015 opdateret af: Douglas Seals, University of Colorado, Boulder
The investigators hypothesize that reducing salt in the diet will improve the function of blood vessels in middle aged and older adults with moderately elevated systolic blood pressure, by increasing the amount of BH4 and nitric oxide in your blood vessels and reducing the amount of oxidative stress.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The improvement in blood vessel function will be determined over a 10 week period. Subjects will be randomly assigned to either a 'low salt' condition (placebo pills + 1200 mg dietary sodium) or a 'normal salt' condition (2300 mg sodium chloride pills + 1200 mg dietary sodium) and monitored for 5 weeks. After the initial set of 5 weeks, the subjects are switched into the opposite condition, completing the cross-over study design. During weeks 1-4 and 6-9, subjects are monitored weekly with 24 hour urine collections and diet logs. The assessment of the primary outcome (blood vessel function) is completed during weeks 5 and 10. BH4 and ascorbic acid are also administered during weeks 5 and 10 to measure the effects of sodium intake on endogenous BH4 levels and vascular oxidative stress.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

17

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80309
        • Clinical Translational Research Center

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

50 år til 79 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 50-79 years of age
  • SBP 130-159 mmHg

Exclusion Criteria:

  • Have been sick with an infection in the past two weeks
  • Are currently sick or have ongoing health problems such as kidney or CVD
  • Have lost more than 11 lbs. in the last 3 months
  • Are taking any type of antioxidants
  • Smoke or have alcohol problems
  • Have blood glucose levels higher than 126 mg/dL
  • Have resting SBP below or less than 100 mmHg or greater than 159 mmHg
  • Have a resting diastolic blood pressure greater than 99 mmHg
  • Have a BMI greater than 40 kg/m^2
  • Are presently consuming less than 9 or greater than 18 grams of salt / day
  • Have a baseline FMD of greater than 6%
  • Are taking any of the following types of drugs: blood thinners, anti-seizure medications, ant-inflammatory drugs
  • Participate in any high endurance athletic training
  • Taking Hormone Replacement Therapy
  • Have not been post-menopausal for at least 1 year

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: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Normal sodium
Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake. Subjects then cross-over to the low sodium condition in the second half of the study.
Medicin: Slow sodium tablets
The normal salt condition is maintained with 2300 mg / day in the form of slowly released salt (NaCl) tablets.
Andet: Low sodium
Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet. Subjects then cross-over to the normal sodium condition in the second half of the study.
Andet: placebo
Placebo tablets are administered to maintain the low sodium condition.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improved Flow Mediated Dilation
Tidsramme: Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first)
FMD is analyzed at weeks 5 and 10 or after each condition in this cross-over study design. Subjects are randomly assigned to a low salt or normal salt condition for the first set of 5 weeks and then crossed over to the other condition for the second set of 5 weeks.
Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vascular Oxidative Stress
Tidsramme: Immediately following acute infusion of ascorbic acid on Weeks 5 and 10
Change in FMD following acute infusion of ascorbic acid (a dose known to scavenge superoxide) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of vascular oxidative.
Immediately following acute infusion of ascorbic acid on Weeks 5 and 10
BH4 Bioavailability
Tidsramme: Immediately following acute administration of BH4 on Weeks 5 and 10
Change in FMD following acute oral tetrahydrobiopterin (BH4) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability.
Immediately following acute administration of BH4 on Weeks 5 and 10

Samarbejdspartnere og efterforskere

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

Sponsor

University of Colorado, Boulder

Samarbejdspartnere

National Institute on Aging (NIA)

Efterforskere

  • Ledende efterforsker: Kristen L Jablonski, PhD, University of Colorado, Boulder

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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. februar 2009

Primær færdiggørelse (Faktiske)

1. januar 2012

Studieafslutning (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først indsendt

23. marts 2012

Først indsendt, der opfyldte QC-kriterier

28. marts 2012

Først opslået (Skøn)

29. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B5114
  • F31AG033994 (U.S. NIH-bevilling/kontrakt)

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 .

Kliniske forsøg med Forhøjet blodtryk

Kliniske forsøg med Slow sodium tablets

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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