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The Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function (KaNa)

9 sierpnia 2012 zaktualizowane przez: Wageningen University

Study on the Effects of Sodium and Potassium on Blood Pressure, Vascular Function and Renal Function in Untreated (Pre)Hypertensive Subjects

To determine the effect of (1) increased sodium intake and (2) increased potassium intake on blood pressure, vascular function and renal function in untreated (pre)hypertensive subjects.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is a randomized, double-blind, placebo controlled cross-over feeding study.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Holandia
      • Wageningen, Holandia, 6703 HD
        • Wageningen University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat do 90 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • (Pre)hypertension, defined as office SBP: 130-159 mmHg;
  • No use of antihypertensive, lipid-lowering, anticoagulant or other cardiovascular medication;
  • Age at start of the ≥ 40 years;

  • Apparently healthy:

    • No reported current or previous metabolic diseases
    • No history of cardiovascular diseases
    • No history of renal, liver or thyroid diseases
    • No history of gastrointestinal diseases
    • No diabetes mellitus
    • Fasting laboratory parameters within normal range: renal function (serum creatinine, ureum), liver function (ALAT, ASAT, ɣ-GT) and serum glucose.

Exclusion Criteria:

  • Body mass index > 40 kg/m²;
  • Smoking
  • Secondary hypertension;
  • Weight loss or weight gain of 5 kg or more during the last 2 months;
  • Usage of non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, naproxen) and not able or willing to stop taking them from at least 4 weeks prior to the study.
  • Medical treatment that may affect blood pressure and not able (or willing) to stop taking them;
  • Women taking oral contraceptives or estrogen replacement therapy
  • Taking nutritional supplements and unwilling to discontinue;
  • Women lactating, pregnant or intend to become pregnant during study;
  • Reported dietary habits: medically prescribed diet, slimming diet;
  • Reported alcohol consumption > 21 units/w (female subjects) or >28 units/w (male subjects);
  • Unable or unwilling to consume one meal every workday at the university, or to consume the prescribed study diet for 13 weeks;
  • Problems with consuming the supplements or following the study guidelines;
  • Unwilling to undergo home or office blood pressure measurements;
  • Recent blood donation i.e. 1 month (male subjects) or 2 months (female subjects) prior to the study and planned donation during the study period;
  • Reported intense sporting activities > 10 h/w;
  • Not agreeing to be informed about unexpected and medically relevant personal test-results
  • Participation in another biomedical trial less than 2 months before the start of the study or at the same time;
  • No informed consent signed.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Sodium
For 4 weeks subjects will consume 3 grams of sodium by the intake of capsules on top of a low-sodium (2 grams of sodium), low-potassium (2 grams of potassium) diet
Suplement diety: Sodium
Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams.
Aktywny komparator: Potassium
For 4 weeks subjects will consume 3 grams of potassium by the intake of capsules on top of a low-sodium (2 grams of sodium), low-potassium (2 grams of potassium) diet.
Suplement diety: Sodium
Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams.
Lek: Potassium
Potassium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a potassium intake of 3 grams.
Komparator placebo: Placebo
For 4 weeks subjects will consume placebo capsules (content: cellulose) on top of a low-sodium low-potassium diet
Suplement diety: Sodium
Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams.
Lek: Placebo
Placebo (cellulose, provided by Microz, Geleen, Netherlands): 8 capsules per day.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Endothelium-dependent flow-mediated dilation comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Ramy czasowe: Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Ultra-sonography (brachial artery) + Picus system
Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in blood pressure comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Ramy czasowe: Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)

Includes:

Office BP (Dinamap, 4 consecutive measurements with 2-min intervals) ABPM (Spacelab; 1x24h, at baseline, week 5, week 9, week 13)
Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Change in Pulse Wave Velocity comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Ramy czasowe: Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)

Device: SphygmoCor (tonometry)

Parameters: Pulse Wave Velocity and at baseline, week 5, week 9 and week 13
Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Change in vasomotion comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Ramy czasowe: Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Device: PeriFlux 5000 (Perimed, Sweden0
Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Change in Biomarkers of endothelial function comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Ramy czasowe: Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Plasma analysis of endothelin-1, ADMA, MCP-1, sVCAM-1, sICAM-1, sE-selectin, sTM, CRP, SAA, IL-6, IL-8, TNF-α, vWF, nitric oxide
Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Change in renal function comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Ramy czasowe: Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
eGFR, serum creatinine (at screening also used as safety parameter)
Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Change in cardiovascular parameters in plasma comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Ramy czasowe: Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, insulin and glucose (at screening also used as safety parameter)
Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Liver function parameters
Ramy czasowe: Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Montoring liver function parameters for safety: includes ALAT, ASAT and ɣ-GT
Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
24-hour urinary mineral excretions
Ramy czasowe: Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Sodium and potassium (as compliance markers)
Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
24-hour excretion of protein, albumin and creatinine
Ramy czasowe: Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
In addition, protein is assessed in spot urine during screening using a dipstick test
Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Adverse events
Ramy czasowe: Every day
Patient diary for occasions of illness, hospitalizations, medication use and other information on potential side effects
Every day
Anthropometric measurements
Ramy czasowe: Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Body weight (weekly), height (only at baseline), waist circumference (baseline and every 4 weeks)
Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Heart rate
Ramy czasowe: Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Dinamap, 4 consecutive measurements with 2-min intervals
Screening. Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Food frequency questionnaire
Ramy czasowe: Screening
Screening
Change in Pulse Wave Analysis comparing (1) high sodium, low potassium intake and (2) low sodium, high potassium intake with low sodium, low potassium intake.
Ramy czasowe: Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)
Device: SphygmoCor (tonometry)
Baseline at week 1 (t=0). After intervention period 1 at week 5 (t=1). After intervention period 2 at week 9 (t=2). After intervention period 3 at week 13 (t=3)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Wageningen University

Współpracownicy

Top Institute Food and Nutrition

Śledczy

  • Główny śledczy: Johanna M Geleijnse, PhD, Wageningen University, Division of Human Nutrition

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 stycznia 2012

Zakończenie podstawowe (Rzeczywisty)

1 lipca 2012

Ukończenie studiów (Rzeczywisty)

1 sierpnia 2012

Daty rejestracji na studia

Pierwszy przesłany

20 marca 2012

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 kwietnia 2012

Pierwszy wysłany (Oszacować)

10 kwietnia 2012

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

10 sierpnia 2012

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 sierpnia 2012

Ostatnia weryfikacja

1 sierpnia 2012

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • KaNa-trial

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