Oxidized Omega-3 Supplements With Different Oxidation (GPTPASPAD)

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: Less oxidized oil and diet; Dietary supplement: More oxidized oil and diet; Drug: Hypercholesterolemic diet

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Pharmacy Iborra Campos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: 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. 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; Other Names: less oxidized oil
Experimental: 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	Dietary supplement: 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. 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; Other Names: More oxidized oil
Experimental: 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	Drug: 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. 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Miguel Hernandez de Elche
• Collaborators: Instituto de Salud Carlos III; University of Alicante
• Investigators: Principal Investigator: Elena García, PDI, Universidad Miguel Hernandez de Elche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: February 19, 2013
• First Submitted That Met QC Criteria: February 25, 2013
• First Posted (Estimate): February 27, 2013

Study Record Updates

• Last Update Posted (Estimate): August 3, 2015
• Last Update Submitted That Met QC Criteria: July 12, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: triglycerides; fish oil; lipid peroxidation; blood cholesterol; blood lipid profile; commercial pills; Circulating lipidic profile
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: Elena García-García; Enrique Roche Collado (Other Grant/Funding Number: Instituto de Salud Carlos III-FEDER PS09/01093); Vicente Micol Molina (Other Grant/Funding Number: PROMETEO/2012/007 from Generalitat Valenciana)