Oxidized Omega-3 Supplements With Different Oxidation (GPTPASPAD)
2015年7月12日 更新者：Elena García García、Universidad Miguel Hernandez de Elche
Effect of Omega-3 Dietary Supplements With Different Oxidation Levels in the Lipidic Profile of Women: a Randomized Controlled Trial
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
71
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Alicante
-
Elche、Alicante、西班牙、03202
- Pharmacy Iborra Campos
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
25年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
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.
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
其他名称：
|
|
实验性的：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.
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.
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
其他名称：
|
|
实验性的：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.
Participants from group 3 only took diet and no capsules.
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.
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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
大体时间：Days 1 and 30
|
In this table the investigators present the weight (kilogram) of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
大体时间：Days 1 and 30
|
In this table the investigators present the height of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
|
Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
大体时间：Days 1 and 30
|
In this table the investigators present the Body Mass Index of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
|
Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)
大体时间：Days 1 and 30
|
In this table the investigators present the hip/waist ratio of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
|
Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
大体时间：Days 1 and 30
|
In this table the investigators present the systolic pressure of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
|
Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
大体时间：Days 1 and 30
|
In this table the investigators present the diastolic pressure of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
|
Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
大体时间：Days 1 and 30
|
In this table the investigators present the glucose of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
|
Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
大体时间：Days 1 and 30
|
In this table the investigators present the cholesterol of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
|
Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
大体时间：Days 1 and 30
|
In this table the investigators present the Triglycerides (TGs) of the three intervented groups.
Data are mean ± sem.
|
Days 1 and 30
|
|
Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).
大体时间：Days 1 and 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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Elena García, PDI、Universidad Miguel Hernandez de Elche
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年10月1日
初级完成 (实际的)
2011年2月1日
研究完成 (实际的)
2011年4月1日
研究注册日期
首次提交
2013年2月19日
首先提交符合 QC 标准的
2013年2月25日
首次发布 (估计)
2013年2月27日
研究记录更新
最后更新发布 (估计)
2015年8月3日
上次提交的符合 QC 标准的更新
2015年7月12日
最后验证
2015年7月1日
更多信息
与本研究相关的术语
其他研究编号
- Elena García-García
- Enrique Roche Collado (其他赠款/资助编号：Instituto de Salud Carlos III-FEDER PS09/01093)
- Vicente Micol Molina (其他赠款/资助编号：PROMETEO/2012/007 from Generalitat Valenciana)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.