Oxidized Omega-3 Supplements With Different Oxidation (GPTPASPAD)

Miguel Hernández University of Elche

Status: Completed

Conditions: Overweight

Treatments: Drug: Hypercholesterolemic diet; Dietary Supplement: Less oxidized oil and diet; Dietary Supplement: More oxidized oil and diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01799720

Vicente Micol Molina (Other Grant/Funding Number)

Enrique Roche Collado (Other Grant/Funding Number)

Elena García-García

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: Female

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 3 patient groups

Less oxidized oil and diet

Experimental group

Description:

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

Treatment:

Dietary Supplement: Less oxidized oil and diet

More oxidized oil and diet

Experimental group

Description:

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

Treatment:

Dietary Supplement: More oxidized oil and diet

Hypercholesterolemic diet

Experimental group

Description:

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

Treatment:

Drug: Hypercholesterolemic diet