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Effect of Mediterranean and Hypolipemic Reduction Diet in Obese Patients

3. oktober 2014 opdateret af: Prof. dr. sc. Velimir Božikov, University of Zagreb

Effect of the Mediterranean Diet and Hypolipemic Reduction Diet in Combination With Exercise in Obese Croatian Population- 1-year Randomized Controlled Trial

The purpose of this study is to evaluate the combined effect of physical activity and adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative stress in obese patients enrolled in the weight management reduction program.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

124

Fase

  • Ikke anvendelig

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

18 år til 69 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • BMI ≥ 30 kg/m2

Exclusion Criteria:

  • newly diagnosed diabetes, hypertension or cardiovascular disease
  • change in antihypertensive therapy and antidiabetic therapy in the period of 3 months prior to the commencement of the study
  • insulin therapy
  • alcohol consumption >500 g of alcohol/week in the last year
  • pregnancy or breast feeding
  • use of drugs affecting weight control (eg. weight loss medication or systemic glucocorticoids)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mediterranean diet+physical activity
Mediterranean diet based on 1573 kcal/day with the goal of consumption of 30 ml/day of olive oil, 56g/week of nuts, 3-4 servings/week of fish, 3 servings/day of fruits, 2-3 servings/day of vegetables, 3 servings/week legumes and white meat instead of red meat
Adfærdsmæssigt: Weight reduction program
Aktiv komparator: Hypolipemic reduction diet+physical activity
Hypolipemic reduction diet based on 1287 kcal/day with the goal of consumption of 3 servings/day of fruits, 2-3 servings/day of vegetables, 3 servings/week legumes and white meat instead of red meat, non-fat or low-fat dairy products
Adfærdsmæssigt: Weight reduction program

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Oxidative stress
Tidsramme: The outcome measure is studied at baseline, 1 and 12 months
The outcome measure is studied at baseline, 1 and 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body weight (kg)
Tidsramme: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
Waist circumference (cm)
Tidsramme: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
Fasting glycemia
Tidsramme: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
Lipid profile (HLD, LDL, TC,)
Tidsramme: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
Urate
Tidsramme: The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months
The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months
Blood pressure (mmHg)
Tidsramme: The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months
The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months
Physical activity level
Tidsramme: The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months
IPAQ-SF for record on physical activity during 7 last 7 days.
The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months
Quality of life
Tidsramme: The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months
SF-36 questionnaire
The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months
Dietary intakes
Tidsramme: The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months
Food Frequency Questionnaire 7-day food diary
The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Zagreb

Samarbejdspartnere

University Hospital Dubrava

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. oktober 2008

Primær færdiggørelse (Faktiske)

1. september 2013

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

23. september 2014

Først indsendt, der opfyldte QC-kriterier

3. oktober 2014

Først opslået (Skøn)

8. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 006-0000000-3521

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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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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