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Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile (cereals)

24. august 2015 opdateret af: Elena García García, Universidad Miguel Hernandez de Elche

Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile: a Randomized Simple Controlled Trial

The inclusion of breakfast cereals enriched with omega-3 for female users of a pharmacy who had some lipidic profiles to the limit is highly conditioned by their nutritional acceptance. The main objective is to assess the effect of breakfast cereals intake with omega-3 on women lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce the small dyslipidemia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The investigators performed an intervention including 133 women (age 25-70 years). Participants were randomly and single-blind distributed into three groups: Group 1 (n=38) consumed cereal with omega-3 (Cw-3 + D), cereal (C) and diet (D), Group 2 (n=38). Volunteers consumed (C) + (D) and Group 3 (n=37) consumed only diet. All groups followed a limit levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and glucose were determined at the beginning and end of a 30-day test.

Statistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint Technologies, Inc. Warrington, VA, USA); likewise, significance was defined at p ≤ 0.05. Data are reported as mean ± standard error of the mean (sem). Intra-group statistical comparisons were performed using the following hypothesis tests, both parametric and non-parametric: t-test, sign test and signed rank test for paired samples. Inter-group statistical comparisons were performed using the one-way analysis of variance and the Kruskal-Wallis hypothesis tests. Also, Fisher's least significant difference (LSD) Multiple Range Test and Tukey's honestly significant difference (HSD) were used in order to determine which means were significantly different from the others. In addition, Generalized Multiple Regression was used to statistically analyze the relationships between the variations in the lipid profile and the different factors included in the study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

96

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Spanien
    • Alicante
      • Elche, Alicante, Spanien, 03202
        • Pharmacy Iborra Campos

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

25 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • voluntarily participation
  • ages between 25-70 years
  • undergoing dyslipidemia
  • with no pharmacological treatment
  • cholesterol (250-300 mg/dL)
  • triglycerides (160-175 mg/dL)

Exclusion Criteria:

  • subjects undergoing any pharmacological treatment that may influence lipid metabolism
  • lipid levels outside the range of those specified in the inclusion criteria
  • subjects that were deemed to be unlikely to complete the treatment or to cooperate fully at the investigator´s discretion.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cereals
For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet. The energy intake of the designed diet was similar into the three groups (ranging 1900-2000 Kcal per day).
Kosttilskud: Cereals
The participants were randomly single blind controlled trial distributed into three groups: (1, n =38), (2, n =38), (3, n =37). For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet.
Andre navne:
  • Papilla multicereales con Omega-3 0628413
  • Papilla multicereales 0528413

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Tidsramme: 30 days
Circulating parameters of cholesterol total
30 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Tidsramme: 30 days
In this table the investigators present the weight of the three intervented groups
30 days
Cholesterol HDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Tidsramme: 30 days
Circulating parameters of cholesterol HDL
30 days
Cholesterol LDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Tidsramme: 30 days
Circulating parameters of cholesterol LDL
30 days
Triglycerides characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Tidsramme: 30 days
Circulating parameters of triglycerides
30 days
Glucose characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Tidsramme: 30 days
Circulating parameters of glucose
30 days
BMI (Kg/m2) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Tidsramme: 30 days
In this table the investigators present the BMI of the three intervented groups
30 days
Hip/waist measure (cm) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Tidsramme: 30 days
In this table the investigators present the hip / waist measure of the three intervented groups
30 days
Systolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Tidsramme: 30 days
In this table the investigators present the systolic pressure of the three intervented groups
30 days
Diastolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
Tidsramme: 30 days
In this table the investigators present the diastolic pressure of the three intervented groups
30 days

Samarbejdspartnere og efterforskere

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

Sponsor

Universidad Miguel Hernandez de Elche

Samarbejdspartnere

Instituto de Salud Carlos III

Efterforskere

  • Ledende efterforsker: Elena García-García, PDI, Universidad Miguel Hernandez de Elche

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 2013

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først indsendt

23. februar 2014

Først indsendt, der opfyldte QC-kriterier

16. juli 2014

Først opslået (Skøn)

17. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Elena García-García 3
  • Enrique Roche Collado (Andet bevillings-/finansieringsnummer: Instituto de Salud Carlos III-FEDER PS09/01093)

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

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Placeringer

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