Oxidized Omega-3 Supplements With Different Oxidation

Not Applicable

Completed

Conditions: Overweight

Interventions: Dietary Supplement: Less oxidized oil and diet
Drug: Hypercholesterolemic diet
Dietary Supplement: More oxidized oil and diet

Registration Number: NCT01799720

Lead Sponsor: Universidad Miguel Hernandez de Elche

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 71

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Less oxidized oil and diet	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
Hypercholesterolemic diet	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
More oxidized oil and diet	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).	Days 1 and 30	In this table the investigators present the systolic pressure 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).	Days 1 and 30	In this table the investigators present the Body Mass Index 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).	Days 1 and 30	In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem.
Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).	Days 1 and 30	In this table the investigators present the height of the three intervented groups. Data are mean ± sem.
Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)	Days 1 and 30	In this table the investigators present the hip/waist ratio 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).	Days 1 and 30	In this table the investigators present the glucose 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).	Days 1 and 30	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).	Days 1 and 30	In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) 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).	Days 1 and 30	In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem.