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Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

22. maj 2014 opdateret af: Juscelino Tovar, Lund University

Effects of a Synergistic Food Basket on Markers of Metabolic Syndrome Risk in Healthy Mature Women

The study evaluates the effect of a diet combining two different functional concepts on markers associated to cardiometabolic risk. The functional concepts are selected on the basis of their reported ability to influence the inflammatory tonus. It is hypothesized that the medium-term consumption of a diet combining low GI-prebiotic foods may positively influence various biomarkers associated with the risk for developing metabolic syndrome and cardiometabolic disease. Also, the combination of functional mechanisms are expected to result in synergistic effects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The intervention is carried out in healthy women following a randomized crossover design in which an "active" (functional") diet is compared with a control diet formulated in agreement with the Nordic Dietary Recommendations but lacking the functional ingredients of the active regime.

The active diet supplies important daily amounts of dried legumes and wholegrain cereal products.

Each dietary treatment is applied for 4 weeks separated by a 4-6 week washout period. Subjects are encouraged to maintain a stable body weight under the whole trial.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

52

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Sverige
    • Skane
      • Lund, Skane, Sverige, 221 00
        • Antidiabetic Food Centre, Chemical Centre. Lund University

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 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • BMI between 25 and 32 kg/m2

Exclusion Criteria:

  • Fasting blood glucose > 6.1 mmol/L
  • Medication for high blood pressure and/or elevated blood cholesterol

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Active Diet
Subjects eat a diet designed according to the Nordic Dietary Recommendations containing important amounts of specific legume and cereal ingredients that provide substrates for the intestinal microflora (prebiotics)
Andet: Synergistic food basket
A low glycemic index diet enriched in dried legumes and wholegrain cereals is compared with a control regime lacking these functional ingredients for their ability to ameliorate different markers associated with the risk for developing cardiometabolic disease
Eksperimentel: Control diet
Subjects eat a diet designed according to the Nordic Dietary Recommendations but lacks the specific legume and cereal ingredients that provide substrates for the intestinal microflora (prebiotics).
Andet: Synergistic food basket
A low glycemic index diet enriched in dried legumes and wholegrain cereals is compared with a control regime lacking these functional ingredients for their ability to ameliorate different markers associated with the risk for developing cardiometabolic disease

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in LDL cholesterol after each dietary period
Tidsramme: Week 0 and after 4 weeks (Start and End of the intervention arm)
Week 0 and after 4 weeks (Start and End of the intervention arm)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in LDL-cholesterol/HDL-cholesterol after each dietary period
Tidsramme: Week 0 and after 4 weeks (Start and End of the intervention arm)
Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma triglycerides after each dietary period
Tidsramme: Week 0 and after 4 weeks (Start and End of the intervention arm)
Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting CRP after each dietary period
Tidsramme: Week 0 and after 4 weeks (Start and End of the intervention arm)
Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma PYY after each dietary period
Tidsramme: Week 0 and after 4 weeks (Start and End of the intervention arm)
Satiety signalling hormone PYY
Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma insulin after each dietary period
Tidsramme: Week 0 and after 4 weeks (Start and End of the intervention arm)
Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma glucose after each dietary period
Tidsramme: Week 0 and after 4 weeks (Start and End of the intervention arm)
Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma PAI-1 after each dietary period
Tidsramme: Week 0 and after 4 weeks (Start and End of the intervention arm)
Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in BMI after each dietary period
Tidsramme: Week 0 and after 4 weeks (Start and End of the intervention arm)
Body Mass Index
Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in blood pressure after each dietary period
Tidsramme: Week 0 and after 4 weeks (Start and End of the intervention arm)
Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in HOMA-IR after each dietary period
Tidsramme: Week 0 and after 4 weeks (Start and End of the intervention arm)
Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in waist circumference after each dietary period
Tidsramme: Week 0 and after 4 weeks (Start and End of the intervention arm)
Week 0 and after 4 weeks (Start and End of the intervention arm)

Samarbejdspartnere og efterforskere

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

Sponsor

Lund University

Samarbejdspartnere

Anti-Diabetic Food Centre

Efterforskere

  • Studiestol: Inger Björck, PhD Prof., Antidiabetic Food Centre, Lund University
  • Studieleder: Juscelino Tovar, PhD, Antidiabetic Food Centre, Lund University
  • Ledende efterforsker: Maria Johansson, PhD, Antidiabetic Food Centre, Lund University

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.

Generelle publikationer

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. september 2011

Primær færdiggørelse (Faktiske)

1. maj 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

31. januar 2012

Først indsendt, der opfyldte QC-kriterier

2. februar 2012

Først opslået (Skøn)

6. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AFC-Food Basket

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 Metabolisk syndrom

Kliniske forsøg med Synergistic food basket

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in China

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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