Changes Induced by Breakfast Cereals Enriched With Omega-3 in the Lipidic Profile: a Randomized Simple Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
研究概览
简要总结
The inclusion of breakfast cereals enriched with omega-3 for female users of a pharmacy who had some lipidic profiles to the limit is highly conditioned by their nutritional acceptance. The main objective is to assess the effect of breakfast cereals intake with omega-3 on women lipid profile values to the limit, users of a pharmacy in Elche and in this way reduce the small dyslipidemia.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •voluntarily participation
- •ages between 25-70 years
- •undergoing dyslipidemia
- •with no pharmacological treatment
- •cholesterol (250-300 mg/dL)
- •triglycerides (160-175 mg/dL)
排除标准
- •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.
结局指标
主要结局
Cholesterol Total characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.
时间窗: 30 days
Circulating parameters of cholesterol total
次要结局
- Weight (Kg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.(30 days)
- Cholesterol HDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.(30 days)
- Triglycerides characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.(30 days)
- Glucose characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.(30 days)
- Diastolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.(30 days)
- Cholesterol LDL characteristics of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.(30 days)
- Hip/waist measure (cm) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.(30 days)
- Systolic pressure (mmHg) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.(30 days)
- BMI (Kg/m2) of volunteers at the beginning (day 1) and at the end of the study (day 30). Data are mean ± sem.(30 days)
研究者
Elena García García
PhD, PID
Universidad Miguel Hernandez de Elche