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Oxidized Omega-3 Supplements With Different Oxidation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01799720
Acronym
GPTPASPAD
Enrollment
71
Registered
2013-02-27
Start date
2010-10-31
Completion date
2011-04-30
Last updated
2015-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Keywords

blood cholesterol, blood lipid profile, triglycerides, commercial pills, fish oil, lipid peroxidation, Circulating lipidic profile

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.

Interventions

DIETARY_SUPPLEMENTLess 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

DIETARY_SUPPLEMENTMore 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

DRUGHypercholesterolemic 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

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
University of Alicante
CollaboratorOTHER
Universidad Miguel Hernandez de Elche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Participant flow

Recruitment details

The place where women were recruited for our study was a pharmacy located in the city centre of Elche, during October 2010. Elche is an industrial city located in the Southeast of Spain, with a population of 230 000 inhabitants.

Pre-assignment details

Before the survey began, 14 people were discarded from the survey because their cholesterol levels were lower than the inclusion standards. 5 participants decided to withdraw from the survey once it had began. 3 of them abandoned the study voluntarily. 1 left because she was pregnant, and 1 violated the protocol norms and was expelled.

Participants by arm

ArmCount
Less Oxidized Oil and Diet
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.
17
More Oxidized Oil and Diet
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.
17
Only Diet
Participants from group 3 only received the diet. Follow-up 30 days.
18
Total52

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyPregnancy001
Overall StudyProtocol Violation010
Overall StudyWithdrawal by Subject300

Baseline characteristics

CharacteristicMore Oxidized Oil and DietOnly DietLess Oxidized Oil and DietTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants4 Participants3 Participants11 Participants
Age, Categorical
Between 18 and 65 years
13 Participants14 Participants14 Participants41 Participants
Age, Continuous56.82 years
STANDARD_DEVIATION 12.18
51.94 years
STANDARD_DEVIATION 10.8
56.65 years
STANDARD_DEVIATION 12.65
55.14 years
STANDARD_DEVIATION 11.87
Region of Enrollment
Spain
17 participants18 participants17 participants52 participants
Sex: Female, Male
Female
17 Participants18 Participants17 Participants52 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
3 / 200 / 181 / 19
serious
Total, serious adverse events
0 / 200 / 180 / 19

Outcome results

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.

Time frame: Days 1 and 30

ArmMeasureGroupValue (MEAN)Dispersion
Less Oxidized Oil and DietWeight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)Day 170.17 kilogramStandard Error 3.71
Less Oxidized Oil and DietWeight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)Day 3069.38 kilogramStandard Error 3.61
More Oxidized Oil and DietWeight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)Day 168.77 kilogramStandard Error 3.42
More Oxidized Oil and DietWeight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)Day 3067.78 kilogramStandard Error 3.41
DietWeight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)Day 175.15 kilogramStandard Error 3.95
DietWeight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)Day 3074.29 kilogramStandard Error 3.94
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.

Time frame: Days 1 and 30

ArmMeasureGroupValue (MEAN)Dispersion
Less Oxidized Oil and DietBody Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 3027.10 kilogram / square metreStandard Error 1.34
Less Oxidized Oil and DietBody Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 127.43 kilogram / square metreStandard Error 1.41
More Oxidized Oil and DietBody Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 3026.94 kilogram / square metreStandard Error 1.36
More Oxidized Oil and DietBody Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 128.65 kilogram / square metreStandard Error 2.13
DietBody Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 129.00 kilogram / square metreStandard Error 1.5
DietBody Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 3028.64 kilogram / square metreStandard Error 1.45
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.

Time frame: Days 1 and 30

ArmMeasureGroupValue (MEAN)Dispersion
Less Oxidized Oil and DietCholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 1246.64 milligram / decilitreStandard Error 12.92
Less Oxidized Oil and DietCholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 30217.76 milligram / decilitreStandard Error 8.98
More Oxidized Oil and DietCholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 30237.52 milligram / decilitreStandard Error 7.54
More Oxidized Oil and DietCholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 1232.94 milligram / decilitreStandard Error 12.55
DietCholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 30227.22 milligram / decilitreStandard Error 6.02
DietCholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 1236.78 milligram / decilitreStandard Error 4.17
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.

Time frame: Days 1 and 30

ArmMeasureGroupValue (MEAN)Dispersion
Less Oxidized Oil and DietDiastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 177.2 millimetres of mercuryStandard Error 0.26
Less Oxidized Oil and DietDiastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 3068.9 millimetres of mercuryStandard Error 0.21
More Oxidized Oil and DietDiastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 173.9 millimetres of mercuryStandard Error 0.34
More Oxidized Oil and DietDiastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 3075.1 millimetres of mercuryStandard Error 0.29
DietDiastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 173.3 millimetres of mercuryStandard Error 0.34
DietDiastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 3072.8 millimetres of mercuryStandard Error 0.2
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.

Time frame: Days 1 and 30

ArmMeasureGroupValue (MEAN)Dispersion
Less Oxidized Oil and DietGlucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 1103.35 milligram / decilitreStandard Error 3.18
Less Oxidized Oil and DietGlucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 30116.24 milligram / decilitreStandard Error 4.3
More Oxidized Oil and DietGlucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 1108.96 milligram / decilitreStandard Error 11.11
More Oxidized Oil and DietGlucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 30111.37 milligram / decilitreStandard Error 2.46
DietGlucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 199.72 milligram / decilitreStandard Error 4.53
DietGlucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 30108.26 milligram / decilitreStandard Error 2.55
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.

Time frame: Days 1 and 30

ArmMeasureGroupValue (MEAN)Dispersion
Less Oxidized Oil and DietGlutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 122.70 Units / litreStandard Error 2.71
Less Oxidized Oil and DietGlutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 3020.69 Units / litreStandard Error 3.34
More Oxidized Oil and DietGlutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 124.90 Units / litreStandard Error 2.96
More Oxidized Oil and DietGlutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 3018.46 Units / litreStandard Error 1.62
DietGlutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 3019.94 Units / litreStandard Error 2.19
DietGlutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 123.54 Units / litreStandard Error 3.92
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.

Time frame: Days 1 and 30

ArmMeasureGroupValue (MEAN)Dispersion
Less Oxidized Oil and DietHeight (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 11.60 metresStandard Error 0.02
Less Oxidized Oil and DietHeight (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 301.60 metresStandard Error 0.02
More Oxidized Oil and DietHeight (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 11.59 metresStandard Error 0.01
More Oxidized Oil and DietHeight (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 301.59 metresStandard Error 0.01
DietHeight (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 11.61 metresStandard Error 0.01
DietHeight (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 301.61 metresStandard Error 0.01
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.

Time frame: Days 1 and 30

ArmMeasureGroupValue (MEAN)Dispersion
Less Oxidized Oil and DietHip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)Day 186.5 ratio*100Standard Error 2.1
Less Oxidized Oil and DietHip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)Day 3086.5 ratio*100Standard Error 2.1
More Oxidized Oil and DietHip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)Day 187.2 ratio*100Standard Error 3
More Oxidized Oil and DietHip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)Day 3087.2 ratio*100Standard Error 3
DietHip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)Day 186.0 ratio*100Standard Error 2.9
DietHip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)Day 3086.0 ratio*100Standard Error 2.9
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.

Time frame: Days 1 and 30

ArmMeasureGroupValue (MEAN)Dispersion
Less Oxidized Oil and DietSystolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 1129.9 millimetres of mercuryStandard Error 0.5
Less Oxidized Oil and DietSystolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 30118.2 millimetres of mercuryStandard Error 0.42
More Oxidized Oil and DietSystolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 1123.7 millimetres of mercuryStandard Error 0.66
More Oxidized Oil and DietSystolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 30120.2 millimetres of mercuryStandard Error 0.41
DietSystolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 1118.6 millimetres of mercuryStandard Error 0.37
DietSystolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 30119.4 millimetres of mercuryStandard Error 0.41
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.

Time frame: Days 1 and 30

ArmMeasureGroupValue (MEAN)Dispersion
Less Oxidized Oil and DietTriglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 1164.41 milligram / decilitreStandard Error 15.43
Less Oxidized Oil and DietTriglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 30125.52 milligram / decilitreStandard Error 12.34
More Oxidized Oil and DietTriglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 1160.41 milligram / decilitreStandard Error 11.34
More Oxidized Oil and DietTriglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 30116.88 milligram / decilitreStandard Error 11.43
DietTriglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 1174.83 milligram / decilitreStandard Error 19.83
DietTriglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).Day 30130.04 milligram / decilitreStandard Error 10.18

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026