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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014