Effects of Phytosterol-rich Wheat Corn Germ Blended Oil on Immune Function, Oxidative Stress, Serum Metabolites and Intestinal Flora in Dyslipidaemic Population: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- glutathione
研究概览
简要总结
The goal of this clinical trial is to explore the role of wheat and corn germ blended oils in regulating oxidative stress and immunomodulation in dyslipidaemic populations, to explore their effects on intestinal flora, antioxidant and immunomodulation. The main questions it aims to answer are:
- How does phytosterol-rich wheat corn germ blended oil affect oxidative stress and immune function in dyslipidaemic people compared to peanut oil?
- How does phytosterol-rich wheat corn germ blended oil affect serum metabolites, serum fatty acid profile, and intestinal flora in dyslipidaemic populations compared to peanut oil? What are the specific mechanisms involved?
Participants will be randomly assigned to the intervention and control groups, the packaging of germ oil and peanut oil will have a uniform appearance, and participants will be instructed to replace their household cooking oils with the distributed cooking oil for three months, in addition to replacing all the canteens in the staff units with the trial oil for more than three months. Participants did not know who was the control oil, germ oil or peanut oil, and both were randomly distributed to different groups of participants by the third-party supervisors.
Researchers will compare peanut oil to see if phytosterol-rich germ oil can improve oxidative stress and immune function in dyslipidaemic populations, in addition to exploring possible underlying mechanisms of improvement using multi-omics techniques.
详细描述
The design of this intervention trial was a randomised controlled trial, in which the included dyslipidaemic population was randomly divided into a wheat corn germ blended oil intervention group and a peanut oil control group, with the male/female ratio, age, and level of basic clinical characteristics balanced between the two groups. The entire test phase consisted of a 14-day washout period and a 3-month intervention period. Participants in the intervention and control groups first entered a 14-day peanut oil washout period, which was followed by a three-month intervention phase. During the intervention phase, two different cooking oils (25-30 g of cooking oil per day according to the recommended intake of the Chinese Nutrition Society) were allocated to the two groups, with peanut oil being consumed by participants in the control group, and germ oil being used to replace the daily cooking oil for participants in the intervention group. After the participants were randomised into groups, they were provided with lunch and dinner according to the Chinese Dietary Guidelines for Residents of China and the local dietary habits of Nanjing, China, and breakfast was provided by the subjects themselves (dietary guidance was given to the subjects during the course of the study, and breakfast recipes were provided uniformly in order to achieve consistency between the two groups), and the intervention period was 3 months. Throughout the project period, all subjects followed their normal dietary habits and maintained a normal level of physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The packaging of intervention oil and control oil was consistent, and the subjects could not distinguish what was blend oil and what was control oil. Blinding was also used for outcome assessors, who did not distinguish between the intervention and control groups.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18-65 with BMI less than 30;
- •At least one item meets the diagnostic criteria for dyslipidemia (2016 Chinese adult dyslipidemia prevention and treatment guide)
- •No serious complications related to liver, kidney, digestive tract, endocrine diseases and chronic diseases;
- •Within 3 months, he did not use the drugs and dietary supplements related to reducing blood fat and weight, and agreed not to use the above foods or drugs during the experiment;
- •Volunteer to participate in this study after listening to the project introduction and sign the informed consent form.
排除标准
- •Pregnant, pregnant or lactating women;
- •Patients with liver and kidney dysfunction, diabetes, coronary heart disease, hyperthyroidism, malignant tumor, asthma and other chronic diseases other than dyslipidemia;
- •Endocrine disease patients, postoperative patients, patients receiving hormone therapy and psychotic patients;
- •Have special eating habits: vegetarian, ketogenic diet (high fat, low carbon water), etc;
- •Those who cannot follow the test requirements.
结局指标
主要结局
glutathione
时间窗: 12 weeks
physiological parameter
Height in metres
时间窗: 12 weeks
Height in metres, physiological parameter
Systolic blood pressure
时间窗: 12 weeks
Units in mmHg. physiological parameter.
diastolic blood pressure
时间窗: 12 weeks
Units in mmHg. physiological parameter.
Weight in kilogram
时间窗: 12 weeks
physiological parameter
body mass index (BMI)
时间窗: 12 weeks
BMI= Weight (kg)/height\^2(m)
waist circumference
时间窗: 12 weeks
Unit in centimetres,physiological parameter
hip measurement
时间窗: 12 weeks
Unit in centimetres,physiological parameter
Serum triglyceride concentrations
时间窗: 12 weeks
physiological parameter
Percentage of CD4+ CD8+ cells
时间窗: 12 weeks
physiological parameter
Percentage of CD16/56+ NK cells
时间窗: 12 weeks
physiological parameter
Serum triglycerides concentrations
时间窗: 12 weeks
physiological parameter
Percentage of CD3+ total T cells
时间窗: 12 weeks
physiological parameter
Percentage of CD4+ T cells
时间窗: 12 weeks
physiological parameter
Percentage of CD8+ T cells
时间窗: 12 weeks
physiological parameter
Immunoglobulin G
时间窗: 12 weeks
physiological parameter
Immunoglobulin A
时间窗: 12 weeks
physiological parameter
Immunoglobulin M
时间窗: 12 weeks
physiological parameter
Immunoglobulin E
时间窗: 12 weeks
physiological parameter
reactive oxygen species
时间窗: 12 weeks
physiological parameter
Serum LDL cholesterol concentrations
时间窗: 12 weeks
physiological parameter
Serum HDL cholesterol concentrations
时间窗: 12 weeks
physiological parameter
Percentage of CD19+ B cells
时间窗: 12 weeks
physiological parameter
Complement C3
时间窗: 12 weeks
physiological parameter
superoxide dismutase
时间窗: 12 weeks
physiological parameter
malondialdehyde
时间窗: 12 weeks
physiological parameter
次要结局
- leptin(12 weeks)
- Transforming growth factor-β(12 weeks)
- diamine oxidase(12 weeks)
- endotoxin(12 weeks)
- Lipoprotein a(12 weeks)
- Number of participants who smoke(12 weeks)
- Number of participants taking lipid-lowering drugs(12 weeks)
研究者
Jia-yue Xia
Principal Investigator
Southeast University, China