Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile (cereals)
Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile: a Randomized Simple Controlled Trial
研究概览
详细说明
The investigators performed an intervention including 133 women (age 25-70 years). Participants were randomly and single-blind distributed into three groups: Group 1 (n=38) consumed cereal with omega-3 (Cw-3 + D), cereal (C) and diet (D), Group 2 (n=38). Volunteers consumed (C) + (D) and Group 3 (n=37) consumed only diet. All groups followed a limit levels-cholesterol diet. Circulating total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and glucose were determined at the beginning and end of a 30-day test.
Statistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint Technologies, Inc. Warrington, VA, USA); likewise, significance was defined at p ≤ 0.05. Data are reported as mean ± standard error of the mean (sem). Intra-group 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. Inter-group statistical comparisons were performed using the one-way analysis of variance and the Kruskal-Wallis hypothesis tests. Also, Fisher's least significant difference (LSD) Multiple Range Test and Tukey's honestly significant difference (HSD) were used in order to determine which means were significantly different from the others. In addition, Generalized Multiple Regression was used to statistically analyze the relationships between the variations in the lipid profile and the different factors included in the study.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Alicante
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Elche、Alicante、西班牙、03202
- Pharmacy Iborra Campos
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- voluntarily participation
- ages between 25-70 years
- undergoing dyslipidemia
- with no pharmacological treatment
- cholesterol (250-300 mg/dL)
- triglycerides (160-175 mg/dL)
Exclusion Criteria:
- subjects undergoing any pharmacological treatment that may influence lipid metabolism
- lipid levels outside the range of those specified in the inclusion criteria
- subjects that were deemed to be unlikely to complete the treatment or to cooperate fully at the investigator´s discretion.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cereals
For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet.
The energy intake of the designed diet was similar into the three groups (ranging 1900-2000 Kcal per day).
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The participants were randomly single blind controlled trial distributed into three groups: (1, n =38), (2, n =38), (3, n =37).
For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet.
其他名称：
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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 |
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Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
大体时间：30 days
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Circulating parameters of cholesterol total
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30 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
大体时间：30 days
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In this table the investigators present the weight of the three intervented groups
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30 days
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Cholesterol HDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
大体时间：30 days
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Circulating parameters of cholesterol HDL
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30 days
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Cholesterol LDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
大体时间：30 days
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Circulating parameters of cholesterol LDL
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30 days
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Triglycerides characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
大体时间：30 days
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Circulating parameters of triglycerides
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30 days
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Glucose characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
大体时间：30 days
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Circulating parameters of glucose
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30 days
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BMI (Kg/m2) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
大体时间：30 days
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In this table the investigators present the BMI of the three intervented groups
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30 days
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Hip/waist measure (cm) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
大体时间：30 days
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In this table the investigators present the hip / waist measure of the three intervented groups
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30 days
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Systolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
大体时间：30 days
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In this table the investigators present the systolic pressure of the three intervented groups
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30 days
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Diastolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
大体时间：30 days
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In this table the investigators present the diastolic pressure of the three intervented groups
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30 days
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合作者和调查者
调查人员
- 首席研究员：Elena García-García, PDI、Universidad Miguel Hernandez de Elche
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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