Oxidized Omega-3 Supplements With Different Oxidation (GPTPASPAD)

This study has been completed.
Sponsor:
Collaborators:
Instituto de Salud Carlos III
University of Alicante
Information provided by (Responsible Party):
Elena García García, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier:
NCT01799720
First received: February 19, 2013
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Overweight
Drug: omega 3 supplements

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Effect of Omega-3 Dietary Supplements With Different Oxidation Levels in the Lipidic Profile of Women: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Universidad Miguel Hernandez de Elche:

Primary Outcome Measures:
  • Composite outcome measure: EPA+DHA content, peroxide index and Ks groups [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
    Results are expressed as means ± SEM (sample evaluation method)


Secondary Outcome Measures:
  • Composite outcome measure: Anthropometric characteristics of volunteers [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Results are expressed as means ± SEM (sample evaluation method).

  • Composite outcome measure: Changes in circulating parameters of volunteers [ Time Frame: 30 days. ] [ Designated as safety issue: Yes ]
    Results are expressed as means ± SEM (sample evaluation method).


Enrollment: 57
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: omega 3 supplements
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: (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. Follow-up 30 days
Drug: omega 3 supplements
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: (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. Follow-up 30 days
Other Names:
  • less oxidized oil
  • more oxidized oil

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799720

Locations
Spain
Pharmacy Iborra Campos
Elche, Alicante, Spain, 03202
Sponsors and Collaborators
Universidad Miguel Hernandez de Elche
Instituto de Salud Carlos III
University of Alicante
Investigators
Principal Investigator: Elena García, PDI Miguel Hernández University
  More Information

No publications provided by Universidad Miguel Hernandez de Elche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elena García García, PhD,PID, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier: NCT01799720     History of Changes
Other Study ID Numbers: Elena García-García, Enrique Roche Collado, Vicente Micol Molina, Enrique Roche Collado
Study First Received: February 19, 2013
Last Updated: February 26, 2013
Health Authority: Spain: Ethics Committee
United States: Food and Drug Administration

Keywords provided by Universidad Miguel Hernandez de Elche:
blood cholesterol
blood lipid profile
triglycerides
commercial pills
fish oil
lipid peroxidation
Circulating lipidic profile

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014