Evaluation of the Effects of Egg Consumption and Its Enrichment With Annatto on Biomarkers of Cardiovascular Risk and Satiety in Adults.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Total cholesterol
研究概览
简要总结
Healthy adult volunteers (n= 105; 18-59 years) were randomly allocated to consume daily for 8 weeks, either two whole eggs (egg group), two whole eggs added with annatto (annatto-enriched egg group), or two egg whites (control). Volunteers were asked to continue with the habitual physical activity and diet, except for the consumption of additional eggs, egg whites or annatto.
It is hypothesized that participants consuming eggs would have a less atherogenic lipid profile, feel more satisfied and increase antioxidant levels in blood, compared to the control group. Participants in the annatto-enriched egg group would have greater antioxidant capacity than the egg group and compared to control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-59 years
- •Body Mass Index (BMI): 18,5 - 29,9 kg/m2
- •Healthy volunteers
- •Good disposition to consume either eggs, egg whites or eggs added with annatto
- •To have signed the informed consent
排除标准
- •Fasting blood triglycerides > 500mg/dL, Total Cholesterol > 240mg/dL, glucose > 126mg/dL or diabetes.
- •Blood pressure: >140/90 mmHg.
- •History or having any of the following: liver, kidney, or heart disease, cancer, endocrine or gastrointestinal disorders -especially those that limit food absorption.
- •Use of medications to lower blood lipids or glucose.
- •Consumption of multivitamins or nutraceuticals.
- •Plan to lose body weight, pregnancy or breastfeeding.
- •Any known allergy or intolerance to eggs or annatto.
结局指标
主要结局
Total cholesterol
时间窗: Change from Baseline Total cholesterol at 8 weeks
Fasting blood total cholesterol in mg/dL
Systolic Blood Pressure
时间窗: Change from Baseline Systolic Blood Pressure at 8 weeks
Systolic blood pressure in mmHg will be used to present the results of this variable, as follow: e.g. 130 mmHg
Triglycerides
时间窗: Change from Baseline Triglycerides at 8 weeks
Fasting blood triglycerides in mg/dL
Blood lutein levels
时间窗: Change from Baseline Blood lutein levels at 8 weeks
Fasting blood lutein levels in micrograms per mL
Blood bixin levels
时间窗: Change from Baseline Blood bixin levels at 8 weeks
Fasting blood bixin levels in %
Apolipoprotein B (ApoB)
时间窗: Change from Baseline ApoB at 8 weeks
Fasting blood ApoB in mg/L measured by Nuclear Magnetic Resonance
Very low-density lipoprotein (VLDL) cholesterol
时间窗: Change from Baseline VLDL cholesterol at 8 weeks
Fasting blood VLDL cholesterol in mg/dL
Body Mass Index (BMI) in kg/m^2: weight in kilograms, height in meters
时间窗: Change from Baseline BMI at 8 weeks
weight and height will be combined to report BMI in kg/m\^2
Low-density lipoprotein (LDL) cholesterol
时间窗: Change from Baseline LDL cholesterol at 8 weeks
Fasting blood LDL cholesterol in mg/dL
Waist circumference
时间窗: Change from Baseline Waist circumference at 8 weeks
Waist circumference in centimeters measured at the superior border of the iliac crest
Triglyceride-Rich lipoprotein (TRLP) size
时间窗: Change from Baseline TRLP size at 8 weeks
Fasting blood subclasses (Large, medium, small) of TRLP in nmol/L measured by Nuclear Magnetic Resonance
Low-density lipoprotein (LDL) size
时间窗: Change from Baseline LDL size at 8 weeks
Fasting blood subclasses (Large, medium, small) of LDL in nmol/L measured by Nuclear Magnetic Resonance
High-density lipoprotein (HDL) size
时间窗: Change from Baseline HDL size at 8 weeks
Fasting blood subclasses (Large, medium, small) of HDL in μmol/L measured by Nuclear Magnetic Resonance
High-density lipoprotein (HLDL) cholesterol
时间窗: Change from Baseline HDL cholesterol at 8 weeks
Fasting blood HLDL cholesterol in mg/dL
Glucose
时间窗: Change from Baseline Glucose at 8 weeks
Fasting blood glucose in mg/dL
Diastolic Blood Pressure
时间窗: Change from Baseline Diastolic Blood Pressure at 8 weeks
Diastolic blood pressure in mmHg will be used to present the results of this variable, as follow: e.g. 85 mmHg
Ghrelin
时间窗: Change from Baseline Ghrelin at 8 weeks
Ghrelin in pg/mL
Visual Analog Scale (VAS) to Measure Perceived Hunger and Satiety
时间窗: Change from Baseline VAS of Hunger and Satiety at 8 weeks
"Visual Analog Scale to measure perceived hunger and satiety" to complete in the morning, fasting, 5 days before entering the study and the last 5 days to end the study (8th week). The VAS consist of 8 questions followed each by a line of 10cm in which the person marks a position corresponding to his/her feelings about hunger and satiety. A higher score (10) means the person feels with more hunger or satisfied.
Dietary lutein+zeaxanthin levels
时间窗: Change from Baseline Dietary lutein+zeaxanthin levels at 8 weeks
Dietary lutein+zeaxanthin levels in micrograms
Apolipoprotein A1 (ApoA1)
时间窗: Change from Baseline ApoA1 at 8 weeks
Fasting blood ApoA1 in mg/L measured by Nuclear Magnetic Resonance
次要结局
- Ancestry Informative Marker(Baseline)
研究者
Jacqueline Barona Acevedo
Principal Investigator
Universidad de Antioquia