Effect of Supplementation of a High-fat Meal With Sacha Inchi Oil on Postprandial Metabolic and Inflammatory Responses in Adults With Low Physical Activity and Without Abdominal Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Effect of the different meal combinations on change from baseline plasma triglycerides (in mg/dL) at 1 and 4 hours after breakfast
研究概览
简要总结
The postprandial state increases triglyceride-rich lipoproteins and lipopolysaccharide (LPS) levels, promoting cellular lipids accumulation, insulin resistance, increased inflammatory markers and the formation of foam cells, a situation that can have different effects depending the type of dietary fat and presence of metabolic conditions such as abdominal obesity and insulin resistance.
Given that the diet of the Colombian population is rich in saturated fats, and taking into consideration the general resistance to complex dietary changes, the purpose of this study is to evaluate whether Sacha Inchi oil supplementation of a high-fat meal is effective in reducing levels of biochemical markers of cardiovascular risk in adults with and without abdominal obesity.
详细描述
Study population:
The sample will be taken from the population of administrative staff and professors of San Buenaventura University of Cartagena. They will be invited to participate adult men aged between 27 and 59 years with and without abdominal obesity.
Sample size:
To calculate the sample size, a statistical formula was used which allows the comparison of two paired means (repeated measures) in 2 groups. Since there may be a substantial degree of correlation between the magnitude of the baseline measurement and the subsequent, It is necessary to correct the formula for the correlation coefficient, that it was estimated, like the standard deviation (SD), from previous experiences.
The minimum number of subjects (n) for each study group was defined according to the estimate for similar studies in design and study variables, considering as main study variable the levels of triglycerides. Considering the following values: Za = 1,64; Z = 1,28; Mde - Mdc = expected minimum difference = 48; Standard deviation of the primary endpoint = 78,6 and a correlation coefficient of 0,6. With these values the n in both groups was 18 subjects. 21 participants with abdominal obesity and 21 without abdominal obesity will be included providing a 20% of losses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 27 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged between 27 and 59 years.
- •Give voluntary, signed informed consent.
- •Group A: Be non-obese as defined as Waist circumference < 92 cm (Gallo, 2003)
- •Group B: Be obese as defined as Waist circumference > 92 cm
- •Physical inactivity (Adults aged 18-64 who do less than 150 minutes of moderate
- •intensity aerobic physical activity throughout the week or less than 75 minutes of
- •vigorous-intensity aerobic physical activity throughout the week or an equivalent
- •combination of moderate- and vigorous-intensity activity).
排除标准
- •Individuals with known gastrointestinal, renal or cardiovascular diseases, diabetes mellitus, fat intolerance, or those taking medications known to affect lipid metabolism or fat absorption.
研究组 & 干预措施
High fat meal with Sacha Inchi
Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) added with 15ml of Sacha Inchi oil and 125ml of coffee with 10g of sugar
干预措施: High fat meal with Sacha Inchi (Other)
unsupplemented group
Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) and 125ml of coffee with 10g of sugar
干预措施: high saturated fat meal (Other)
结局指标
主要结局
Effect of the different meal combinations on change from baseline plasma triglycerides (in mg/dL) at 1 and 4 hours after breakfast
时间窗: 0, 1 and 4 hours after breakfast
次要结局
- Effect of the different meal combinations on change from baseline plasma High density lipoprotein cholesterol (HDL-Cholesterol , in mg/dL) at 1 and 4 hours after breakfast(0, 1 and 4 hours after breakfast)
- Effect of the different meal combinations on change from baseline plasma Cholesterol (in mg/dL) at 1 and 4 hours after breakfast(0, 1 and 4 hours after breakfast)
- Effect of the different meal combinations on change from baseline plasma Glucose (in mg/dL) at 1 and 4 hours(0, 1 and 4 hours after breakfast)
- Effect of the different meal combinations on change from baseline plasma insulin (in uIU/mL) at 1 and 4 hours(0, 1 and 4 hours after breakfast)
- Effect of the different meal combinations on change from baseline plasma Homeostatic model assessment (HOMA index) (in uIU/mL) at 1 and 4 hours(0, 1 and 4 hours after breakfast)
- Effect of the different meal combinations on change from baseline plasma Lipopolysaccharides (EU/mL) at 1 and 4 hours(0, 1 and 4 hours after breakfast)