Impact of Co-consuming a Plant Sterols-enriched Food Product With a Healthy Eating Pattern Diet on Endothelial Function and Blood Pressure Management in Individuals With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in brachial artery flow-mediated dilation (FMD)
研究概览
简要总结
The purpose of the research is to assess the impact of co-consuming plant sterols-enriched food product as part of a healthy eating pattern diet on endothelial function (brachial artery FMD, vasodilation-related and vasoconstriction-related biomarkers) and blood pressure management (24-hour ambulatory and classic blood pressure) in Singapore individuals with MetS.
详细描述
This is a 13-wk double-blinded, randomized, crossover study design. Following a 1-wk pre-intervention baseline period, subjects will be randomly assigned to follow a healthy eating pattern diet either contain 2.0 g free plant sterols equivalent of their palmityl esters (Plant Sterol Diet) or do not contain plant sterols (Control Diet) for 4 weeks. After a 4-week dietary 'washout' period, they will consume the alternative diet for 4 weeks. The random assignment will be done with SAS 9.4 software. Body size measurement, dietary assessment, brachial artery FMD and blood pressure measurements, and fasting-state blood collection will be conducted at week 1, 5, 9, and 13, which correspond to before and during the last 1 week of the two 4-week intervention periods.
During study week 1 and weeks 6-9, all subjects will consume their habitual, unrestricted self-chosen diets. During study weeks 2-5 and 10-13, all subject will follow a healthy eating pattern diet, referred to as the "My Healthy Plate" designed by HPB. Each subject's energy requirement will be estimated using sex-specific equations and Recommended Dietary Allowances for healthy Singaporean. One-on-one dietary counselling and written instructions for each subject will be provided by a research dietitian and trained research staff to achieve a healthy eating pattern diet. Compliance with the plant sterols consumption will be promoted by frequent online and in-person contact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to give an informed consent;
- •Age>35 years old;
- •Meet any 3 of the 5 following NCEP-ATP III MetS criteria (waist circumference > 90 cm (male), > 80 cm (female); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) < 40 mg/dL (male), < 50 mg/dL (female); systolic or diastolic blood pressure > 130/80 mmHg or on medication);
- •Weight change < 3kg in the past 3 months;
- •No exercising vigorously over the past 3 months;
- •No allergy to plant sterols; no acute illness; not smoking;
- •No drinking more than 2 alcoholic drinks per day;
- •No pregnant, lactating, or planning pregnancy in the next 6 months.
排除标准
- •Unable to give an informed consent;
- •Age<35 years old;
- •Meet less than 3 of following NCEP-ATP III MetS criteria (waist circumference > 90 cm (male), > 80 cm (female); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) < 40 mg/dL (male), < 50 mg/dL (female); systolic or diastolic blood pressure > 130/80 mmHg or on medication);
- •Weight change > 3kg in the past 3 months;
- •Exercise vigorously over the past 3 months;
- •Allergy to plant sterols; no acute illness; not smoking;
- •Drinking more than 2 alcoholic drinks per day;
- •Pregnant, lactate, or plan pregnancy in the next 6 months.
结局指标
主要结局
Change in brachial artery flow-mediated dilation (FMD)
时间窗: Every 4 weeks (Week 1, week 5, week 9, week 13)
Brachial artery FMD will be measured by high-frequency and ultrasonographic imaging.
Change in vasodilation and vasoconstriction related biomarkers
时间窗: Every 4 weeks (Week 1, week 5, week 9, week 13)
Vasodilation and vasoconstriction related biomarkers contains nitric oxide, endothelial nitric oxide synthase, and endothelin-1. They will be measured using the commercially available ELISA assay kits.
Change in blood pressure
时间窗: Every 4 weeks (Week 1, week 5, week 9, week 13)
Classical and 24-hour ambulatory blood pressure: Systolic and diastolic blood pressure and 5-day of 24-hour ambulatory blood pressure will be measured.
次要结局
- Change in diet(Every 4 weeks (Week 1, week 5, week 9, week 13))
- Change in sleep quality (Pittsburgh sleep quality index questionnaire (PSQI))(Every 4 weeks (Week 1, week 5, week 9, week 13))
- Change in skin carotenoid status(Every 4 weeks (Week 1, week 5, week 9, week 13))
- Change in waist circumference(Every 4 weeks (Week 1, week 5, week 9, week 13))
- Change in blood lipid-lipoproteins(Every 4 weeks (Week 1, week 5, week 9, week 13))
- Height(Pre-intervention only)
- Change in weight(Every 4 weeks (Week 1, week 5, week 9, week 13))
研究者
Jung Eun Kim
Assistant Professor
National University of Singapore