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

24. august 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

96

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

25 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Kosttilskudd: 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 navn:
  • Papilla multicereales con Omega-3 0628413
  • Papilla multicereales 0528413

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universidad Miguel Hernandez de Elche

Samarbeidspartnere

Instituto de Salud Carlos III

Etterforskere

  • Hovedetterforsker: Elena García-García, PDI, Universidad Miguel Hernández de Elche

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2013

Primær fullføring (Faktiske)

1. desember 2013

Studiet fullført (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først innsendt

23. februar 2014

Først innsendt som oppfylte QC-kriteriene

16. juli 2014

Først lagt ut (Anslag)

17. juli 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. august 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2015

Sist bekreftet

1. august 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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