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Oxidized Omega-3 Supplements With Different Oxidation (GPTPASPAD)

12 juillet 2015 mis à jour par: Elena García García, Universidad Miguel Hernandez de Elche

Effect of Omega-3 Dietary Supplements With Different Oxidation Levels in the Lipidic Profile of Women: a Randomized Controlled Trial

The oxidation level of unsaturated fatty acid supplements commercialized in capsules could be a serious problem for manufacturers and a risk to consumers; health by ingesting substances whose effects are not desired. Therefore, the main objective of this paper is to analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose the investigators have designed a single-blind, parallel-groups, randomized controlled trial. Finally, 52 women between 25 and 75 years old were randomly distributed into three groups: (1) took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, (2) took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet and (3) no capsules, only received the diet. There was a 30 days follow-up . All groups followed a low cholesterol diet. Circulating glucose, total cholesterol, triglycerides and glutamic pyruvic transaminase were determined at the beginning and end of a 30 day period.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The assignment of women to distinct groups was carried out following the classification criteria established by (NCEP, 2002), and performed by the research team. Women were randomly assigned to one of three parallel groups, in a near 1:1:1 ratio. Group 1 (n=20) took two capsules per day of less oxidized oil (containing 300 mg EPA-DHA per capsule) and diet. Group 2 (n=18) consumed two capsules per day of oxidized oil (containing 300 mg EPA-DHA per capsule) and diet. Finally, group 3 (n=19) performed the diet but did not take any capsule. Therefore, the design was a single-blind (participants did not know what type of capsule they were receiving), parallel-group, randomized controlled trial conducted at the Miguel Hernández University of Elche (Spain).

Statistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint Technologies, Inc. Warrington, VA); likewise, significance was defined at p<0.05. Data are reported as mean standard error of the mean (SEM). Intragroup 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. Intergroup statistical comparisons were performed using the one-way analysis of variance (ANOVA) and the Kruskal-Wallis hypothesis tests. Also, Fisher least significant difference (LSD)Multiple Range Test and Tukey HSD were used in order to determine which means were significantly different from the others.

Methods for additional analyses Generalized multiple regression was used to statistically analyse the relationships between the variations in the lipid profile and the consumption of w-3 dietary supplements.

Type d'étude

Interventionnel

Inscription (Réel)

71

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

25 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • presence of dyslipemia with no indication of drug treatment
  • blood cholesterol levels ranging 250-300 mg/dL
  • triglycerides (TG) 160-175 mg/dL

Exclusion Criteria:

  • pregnancy
  • lactation
  • participation in another supplementary feeding programme

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Less oxidized oil and diet
Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days
Complément alimentaire: Less oxidized oil and diet
Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were distributed into three groups. Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, . Follow-up 30 days
Autres noms:
  • less oxidized oil
Expérimental: More oxidized oil and diet
Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Participants from group 2 took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet . Follow-up 30 days
Complément alimentaire: More oxidized oil and diet
Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were distributed into three groups. Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet . Follow-up 30 days
Autres noms:
  • More oxidized oil
Expérimental: Hypercholesterolemic diet
Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Participants from group 3 only took diet and no capsules. Follow-up 30 days
Médicament: Hypercholesterolemic diet
Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were distributed into three groups. Participants from group 3 only received the diet and no capsules. Follow-up 30 days

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Délai: Days 1 and 30
In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.
Days 1 and 30

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Délai: Days 1 and 30
In this table the investigators present the height of the three intervented groups. Data are mean ± sem.
Days 1 and 30
Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Délai: Days 1 and 30
In this table the investigators present the Body Mass Index of the three intervented groups. Data are mean ± sem.
Days 1 and 30
Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Délai: Days 1 and 30
In this table the investigators present the hip/waist ratio of the three intervented groups. Data are mean ± sem.
Days 1 and 30
Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Délai: Days 1 and 30
In this table the investigators present the systolic pressure of the three intervented groups. Data are mean ± sem.
Days 1 and 30
Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Délai: Days 1 and 30
In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem.
Days 1 and 30
Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Délai: Days 1 and 30
In this table the investigators present the glucose of the three intervented groups. Data are mean ± sem.
Days 1 and 30
Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Délai: Days 1 and 30
In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem.
Days 1 and 30
Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Délai: Days 1 and 30
In this table the investigators present the Triglycerides (TGs) of the three intervented groups. Data are mean ± sem.
Days 1 and 30
Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Délai: Days 1 and 30
In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups. Data are mean ± sem.
Days 1 and 30

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Universidad Miguel Hernandez de Elche

Collaborateurs

Instituto de Salud Carlos III
University of Alicante

Les enquêteurs

  • Chercheur principal: Elena García, PDI, Universidad Miguel Hernandez de Elche

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2010

Achèvement primaire (Réel)

1 février 2011

Achèvement de l'étude (Réel)

1 avril 2011

Dates d'inscription aux études

Première soumission

19 février 2013

Première soumission répondant aux critères de contrôle qualité

25 février 2013

Première publication (Estimation)

27 février 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

3 août 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juillet 2015

Dernière vérification

1 juillet 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Elena García-García
  • Enrique Roche Collado (Autre subvention/numéro de financement: Instituto de Salud Carlos III-FEDER PS09/01093)
  • Vicente Micol Molina (Autre subvention/numéro de financement: PROMETEO/2012/007 from Generalitat Valenciana)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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