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Completed

NCT Number: NCT01799720

Oxidized Omega-3 Supplements With Different Oxidation

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pharmacy Iborra Campos

Elche, Alicante, 03202, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Less oxidized oil and diet

Dietary Supplement

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

More oxidized oil and diet

Dietary Supplement

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

Hypercholesterolemic diet

Drug

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

Primary outcomes

  1. Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)

    Time frame: Days 1 and 30

    In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.

Secondary outcomes

  1. Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).

    Time frame: Days 1 and 30

    In this table the investigators present the height of the three intervented groups. Data are mean ± sem.

  2. Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).

    Time frame: Days 1 and 30

    In this table the investigators present the Body Mass Index of the three intervented groups. Data are mean ± sem.

  3. Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)

    Time frame: Days 1 and 30

    In this table the investigators present the hip/waist ratio of the three intervented groups. Data are mean ± sem.

  4. Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).

    Time frame: Days 1 and 30

    In this table the investigators present the systolic pressure of the three intervented groups. Data are mean ± sem.

  5. Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).

    Time frame: Days 1 and 30

    In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem.

  6. Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).

    Time frame: Days 1 and 30

    In this table the investigators present the glucose of the three intervented groups. Data are mean ± sem.

  7. Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).

    Time frame: Days 1 and 30

    In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem.

  8. Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).

    Time frame: Days 1 and 30

    In this table the investigators present the Triglycerides (TGs) of the three intervented groups. Data are mean ± sem.

  9. Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).

    Time frame: Days 1 and 30

    In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups. Data are mean ± sem.

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Collaborators

  • Instituto de Salud Carlos III
  • University of Alicante

Registry information

Official study title

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

Acronym: GPTPASPAD

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 27, 2013
Registry last updated
Aug 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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