The Precision Nutritional Management for MetS (PNMM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change in body weight from baseline
研究概览
简要总结
The type of cooking oil used is a crucial factor influencing dietary quality. The purpose of this study is to investigate the effects of olive oil and MLCT oil intervention on glucose and lipid homeostasis in patients with MetS.
详细描述
We conducted a 6-month RCT to evaluate the effects of olive oil and MLCT as cooking oils on glucose and lipid homeostasis in patients with MetS; investigate the changes in lipoprotein subfractions and metabolites using NMR spectroscopy, alongside gut microbiota alterations, to elucidate potential mechanisms; and identify baseline variables associated with the anti-obesity effects of olive oil and MLCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants eligible for the study were those with a confirmed MetS diagnosis according to the IDF criteria53, aged between 40 and 70, and who reported infrequent consumption of meals outside the home (≤3 times per week)
排除标准
- •(i) current breastfeeding or pregnancy; (ii) history of cardiovascular disease, including heart disease, coronary artery disease, stroke, cerebral infarction, viral hepatitis (e.g., hepatitis A or B), chronic kidney disease (estimated glomerular filtration rate [GFR] <60 ml/min), or malignancy; (iii) presence of diabetic ketoacidosis or hyperketonemia; (iv) recent alterations in prescribed medication within the previous 6 months; (v) current use of insulin therapy; (vi) consumption of MLCT in the preceding 6 months; (vii) participation in other clinical research studies within the last 6 months; and (viii) premenopausal women
研究组 & 干预措施
Olive oil group
Olive oil use，25-30 g per day for six month
干预措施: Olive oil use (Dietary Supplement)
MLCT oil group
MLCT oil use，25-30 g per day for six month
干预措施: MLCT oil use (Dietary Supplement)
结局指标
主要结局
Change in body weight from baseline
时间窗: 6 month
The investigators will measure body weight of participants before and after treatment.
Change in triglycerides from baseline
时间窗: 6 month
The investigators will measure triglyceride levels in blood samples before and after treatment.
Change in Body fat distribution and muscle conten from baseline
时间窗: 6 month
The whole body of the patient was scanned and analyzed by a DXA (Prodigy Primo, Dalex-Ohmeda, Inc., USA) to measure the total and regional body fat mass (FM) and lean mass.
次要结局
- Change in waist circumference from baseline(6 month)
- Change in MetS indicators from baseline(6 month)
- Change in gut microbiota from baseline(6 month)
- Change in blood metabolome(6 month)
研究者
Yu Zhang
Professor
Zhejiang University