Effect of a Plant Sterol-Fortified Low-fat Milk Product on Plasma Lipid Levels of Humans in Relation to Different Infant Feeding Practices and Later Life Cholesterol Metabolism
试验速览
- 阶段
- 不适用
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in LDL-cholesterol
研究概览
简要总结
The overall goal of this clinical study is to investigate how dietary cholesterol intake influences the plasma Total cholesterol (TC), LDL-Cholesterol levels and cholesterol metabolism between adults who had been breast-fed as infants as a function of the duration of breast feeding and quantity of early cholesterol intake. The study also aims to evaluate the effect of a plant sterol formulation in low fat milk shake in modulating the lipid profile favorably in the study population.
详细描述
Hypothesis 1: To determine the responsiveness of plasma lipid profile including Total cholesterol and LDL cholesterol concentrations to high and low cholesterol diets in adults who been breast-fed as infants for different durations
Hypothesis 2: To determine if differences exist in rates of cholesterol absorption and synthesis in adults, and whether such differences respond to variations in cholesterol intake, between individuals who were breast for different durations.
Hypothesis 3: Consumption of a plant sterol formulation in low-fat milk product will favorably alter lipid profiles compared with control in the study population.
This is a free-living, randomized, crossover trial. This trial is modeled after previously successful functional food trial at the investigators clinic, consistent with current recommendations to decrease Cardiovascular diseases (CVD) risk and improve circulating lipid profiles. The proposed study will include three treatment phases of 4 weeks each, separated by 4-week washout intervals:
Phase 1: Study diets with placebo (240 ml of 2% milk shake; 50 mg cholesterol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Triglycerides (TG) <3.0 mmol/L
- •Body mass index (BMI) between 20 and 30 kg/m2
- •Participants must have been breast-fed at least during the first 6 months of their life
排除标准
- •History of recent (i.e. less than 1 month) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
- •History of chronic use of alcohol (>2 drinks/d), smoking, systemic antibodies, corticosteroids, androgens, or phenytoin
- •Myocardial infarction, coronary artery bypass, kidney disease, liver disease or other major surgical procedures within the last six months,
- •Sitosterolemic patients
- •Recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (i.e. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year)
- •Exercise greater than walking or running 15 miles/wk or 4,000 kcal/wk
- •Participants who have not been breast-fed at all
- •Pregnant or planning for pregnancy during the next 5 month period
结局指标
主要结局
Change in LDL-cholesterol
时间窗: Day 1,2 & 29,30 of each of the 3 phases. Each phase duration is 1 month
次要结局
- Change in Cholesterol Absorption(Day 26-30 of each of the 3 phases. Each phase duration is 1 month)
- Change in Cholesterol Synthesis(Day 26-30 of each of the 3 phases. Each phase duration is 1 month)