Oxidized Omega-3 Supplements With Different Oxidation

NCT ID: NCT01799720

Last Updated: 2015-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-04-30

Brief Summary

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.

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=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.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Less oxidized oil and diet

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: EXPERIMENTAL

More oxidized oil and diet

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: EXPERIMENTAL

Hypercholesterolemic diet

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DRUG

Other Intervention Names

less oxidized oil; More oxidized oil

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

University of Alicante

OTHER

Sponsor Role: collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: lead

Responsible Party

Elena García García

PhD,PID

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena García, PDI

Role: PRINCIPAL_INVESTIGATOR

Universidad Miguel Hernandez de Elche

Locations

Pharmacy Iborra Campos

Elche, Alicante, Spain

Countries

Spain

References

Garcia-Hernandez VM, Gallar M, Sanchez-Soriano J, Micol V, Roche E, Garcia-Garcia E. Effect of omega-3 dietary supplements with different oxidation levels in the lipidic profile of women: a randomized controlled trial. Int J Food Sci Nutr. 2013 Dec;64(8):993-1000. doi: 10.3109/09637486.2013.812619. Epub 2013 Jul 18.

Reference Type: DERIVED

PMID: 23863036 (View on PubMed)

Other Identifiers

Enrique Roche Collado

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Vicente Micol Molina

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Enrique Roche Collado

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Elena García-García

Identifier Type: -

Identifier Source: org_study_id