Oxidized Omega-3 Supplements With Different Oxidation

Overweight Clinical Trial

— GPTPASPAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799720
• Other study ID #: Elena García-García
• Secondary ID: Enrique Roche Co
• Status: Completed
• Phase: N/A
• First received: February 19, 2013
• Last updated: July 12, 2015
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: July 2015
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight

Intervention

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
• 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

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

Locations

Country	Name	City	State
Spain	Pharmacy Iborra Campos	Elche	Alicante

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Instituto de Salud Carlos III, University of Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes