Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01799720
Status:
COMPLETED
Last Update Posted:
2015-08-03
First Post:
2013-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Oxidized Omega-3 Supplements With Different Oxidation
Sponsor:
Universidad Miguel Hernandez de Elche
Organization:
Study Overview
Official Title:
Effect of Omega-3 Dietary Supplements With Different Oxidation Levels in the Lipidic Profile of Women: a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GPTPASPAD
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: