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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: September 18, 2014
Last verified: September 2014
  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
Dietary Supplement: Less oxidized oil and diet
Dietary Supplement: More oxidized oil and diet
Drug: Hypercholesterolemic diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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:
  • Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30) [ Time Frame: Days 1 and 30 ] [ Designated as safety issue: Yes ]
    In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.


Secondary Outcome Measures:
  • Height (Centimetre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). [ Time Frame: Days 1 and 30 ] [ Designated as safety issue: Yes ]
    In this table the investigators present the height of the three intervented groups. Data are ± mean sem.

  • Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). [ Time Frame: Days 1 and 30 ] [ Designated as safety issue: Yes ]
    In this table the investigators present the Body Mass Index of the three intervented groups. Data are mean ± sem.

  • Hip/Waist (Centimetre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). [ Time Frame: Days 1 and 30 ] [ Designated as safety issue: Yes ]
    In this table the investigators present the hip/waist of the three intervented groups. Data are mean ± sem.

  • Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). [ Time Frame: Days 1 and 30 ] [ Designated as safety issue: Yes ]
    In this table the investigators present the systolic pressure of the three intervented groups. Data are mean ± sem.

  • Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). [ Time Frame: Days 1 and 30 ] [ Designated as safety issue: Yes ]
    In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem.

  • Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). [ Time Frame: Days 1 and 30 ] [ Designated as safety issue: Yes ]
    In this table the investigators present the glucose of the three intervented groups. Data are mean ± sem.

  • Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). [ Time Frame: Days 1 and 30 ] [ Designated as safety issue: Yes ]
    In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem.

  • Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). [ Time Frame: Days 1 and 30 ] [ Designated as safety issue: Yes ]
    In this table the investigators present the Triglycerides (TGs) of the three intervented groups. Data are mean ± sem.

  • Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). [ Time Frame: Days 1 and 30 ] [ Designated as safety issue: Yes ]
    In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups. Data are mean ± sem.


Enrollment: 71
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: 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
Dietary Supplement: 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
Other Name: less oxidized oil
Experimental: 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
Dietary Supplement: 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
Other Name: More oxidized oil
Experimental: 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
Drug: 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
Other Name: hypercholesterolemic diet

Detailed Description:

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=17) consumed two capsules per day of oxidized oil (containing 300 mg EPA-DHA per capsule) and diet. Finally, group 3 (n=18) 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's least significant difference (LSD)Multiple Range Test and Tukey's 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.

  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
Results First Received: January 7, 2014
Last Updated: September 18, 2014
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 November 25, 2014