Oxidized Omega-3 Supplements With Different Oxidation
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

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.
    

Intervention name(s): Less oxidized oil and diet; More oxidized oil and diet; Hypercholesterolemic diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): 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; 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; 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 intervention name(s): less oxidized oil; More oxidized oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: blood cholesterol; blood lipid profile; triglycerides; commercial pills; fish oil; lipid peroxidation; Circulating lipidic profile