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Oxidized Omega-3 Supplements With Different Oxidation (GPTPASPAD)

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Less oxidized oil and diet
More oxidized oil and diet
Hypercholesterolemic diet
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring blood cholesterol, blood lipid profile, triglycerides, commercial pills, fish oil, lipid peroxidation, Circulating lipidic profile

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Pharmacy Iborra Campos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Less oxidized oil and diet

More oxidized oil and diet

Hypercholesterolemic diet

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 19, 2013
Last Updated
July 12, 2015
Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Instituto de Salud Carlos III, University of Alicante
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1. Study Identification

Unique Protocol Identification Number
NCT01799720
Brief Title
Oxidized Omega-3 Supplements With Different Oxidation
Acronym
GPTPASPAD
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Instituto de Salud Carlos III, University of Alicante

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
blood cholesterol, blood lipid profile, triglycerides, commercial pills, fish oil, lipid peroxidation, Circulating lipidic profile

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Less oxidized oil and diet
Arm Type
Experimental
Arm Description
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
Arm Title
More oxidized oil and diet
Arm Type
Experimental
Arm Description
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
Arm Title
Hypercholesterolemic diet
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Less oxidized oil and diet
Other Intervention Name(s)
less oxidized oil
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
More oxidized oil and diet
Other Intervention Name(s)
More oxidized oil
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hypercholesterolemic diet
Intervention Description
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 Outcome Measure Information:
Title
Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Description
In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.
Time Frame
Days 1 and 30
Secondary Outcome Measure Information:
Title
Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Description
In this table the investigators present the height of the three intervented groups. Data are mean ± sem.
Time Frame
Days 1 and 30
Title
Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Description
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
Title
Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
Description
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
Title
Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Description
In this table the investigators present the systolic pressure of the three intervented groups. Data are mean ± sem.
Time Frame
Days 1 and 30
Title
Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Description
In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem.
Time Frame
Days 1 and 30
Title
Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Description
In this table the investigators present the glucose of the three intervented groups. Data are mean ± sem.
Time Frame
Days 1 and 30
Title
Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Description
In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem.
Time Frame
Days 1 and 30
Title
Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Description
In this table the investigators present the Triglycerides (TGs) of the three intervented groups. Data are mean ± sem.
Time Frame
Days 1 and 30
Title
Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena García, PDI
Organizational Affiliation
Universidad Miguel Hernandez de Elche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pharmacy Iborra Campos
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23863036
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.
Results Reference
derived

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Oxidized Omega-3 Supplements With Different Oxidation

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