Oxidized Omega-3 Supplements With Different Oxidation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Omega-3 Dietary Supplements With Different Oxidation Levels in the Lipidic Profile of Women: a Randomized Controlled Trial

Conditions
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Overweight

Intervention / Treatment
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* Dietary Supplement: Less oxidized oil and diet
* Dietary Supplement: More oxidized oil and diet
* Drug: Hypercholesterolemic diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Less oxidized oil and diet<br>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<br>* 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<br>* Other names: less oxidized oil;|
| Experimental: More oxidized oil and diet<br>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<br>* 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<br>* Other names: More oxidized oil;|
| Experimental: Hypercholesterolemic diet<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30) | In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem. | Days 1 and 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). | In this table the investigators present the height of the three intervented groups. Data are mean ± sem. | Days 1 and 30 | 
| Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). | In this table the investigators present the Body Mass Index of the three intervented groups. Data are mean ± sem. | Days 1 and 30 | 
| Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30) | In this table the investigators present the hip/waist ratio of the three intervented groups. Data are mean ± sem. | Days 1 and 30 | 
| Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). | In this table the investigators present the systolic pressure of the three intervented groups. Data are mean ± sem. | Days 1 and 30 | 
| Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). | In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem. | Days 1 and 30 | 
| Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). | In this table the investigators present the glucose of the three intervented groups. Data are mean ± sem. | Days 1 and 30 | 
| Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). | In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem. | Days 1 and 30 | 
| Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). | In this table the investigators present the Triglycerides (TGs) of the three intervented groups. Data are mean ± sem. | Days 1 and 30 | 
| Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30). | In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups. Data are mean ± sem. | Days 1 and 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood cholesterol, blood lipid profile, triglycerides, commercial pills, fish oil, lipid peroxidation, Circulating lipidic profile