Clinical trial NCT01799720: Oxidized Omega-3 Supplements With Different Oxidation
Official title: Effect of Omega-3 Dietary Supplements With Different Oxidation Levels in the Lipidic Profile of Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: blood cholesterol
blood lipid profile
triglycerides
commercial pills
fish oil
lipid peroxidation
Circulating lipidic profile
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: University of Alicante
First posted: 2013-02-27
Enrollment: 71
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
timeFrame: Days 1 and 30
Secondary outcomes:
measure: Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
timeFrame: Days 1 and 30
measure: Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
timeFrame: Days 1 and 30
measure: Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
timeFrame: Days 1 and 30
measure: Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
timeFrame: Days 1 and 30
measure: Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
timeFrame: Days 1 and 30
measure: Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
timeFrame: Days 1 and 30
measure: Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
timeFrame: Days 1 and 30
measure: Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
timeFrame: Days 1 and 30
measure: Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
timeFrame: Days 1 and 30
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Pharmacy Iborra Campos
state: Alicante
Study officials:
affiliation: Universidad Miguel Hernandez de Elche
name: Elena García, PDI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.