ChiCTR2200064455Not yet recruitingNot Applicable
牡丹籽油、茶籽油及大豆油对中国健康人群心血管代谢性疾病风险因子的影响及机理研究
高纯 n-3 脂肪酸精深加工及医用食品研究与产业化1 site in 1 country270 target enrollmentStarted: October 9, 2022Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- 血常规指标
Study Overview
Brief Summary
评估世界常用的大豆油和我国特色食用油中的牡丹籽油和茶籽油对年轻非肥胖健康受试者体重变化及相关风险因子的影响，旨在回答上述三种膳食油脂中，哪种油更适合中国健康人群食用的科学问题。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
Eligibility Criteria
- Ages
- 18 to 35 (—)
- Sex
- All
Inclusion Criteria
- •1.中国人民解放军总医院职工；
- •2.18≤年龄≤35；
- •3.18.5≤体质指数（body mass index，BMI）＜27.9；
- •4.愿意在饱腹的状态下吃完提供的食物；
- •5.愿意只吃研究人员提供的食物；
- •6.愿意每天至少一餐（中餐或晚餐）是在干预现场的研究人员监督下进食；
- •7.愿意在干预期间保持基线水准的水果摄入量；
- •8.愿意每天记录食物摄入情况；
- •9.愿意接受知情同意书。
Exclusion Criteria
- •1.收缩压≥140 mm Hg 或者舒张压≥90 mm Hg；
- •2.总胆固醇（total cholesterol，TC）≥6.19 mmol/L；
- •3.低密度脂蛋白胆固醇（low density lipoprotein cholesterol，LDL-C）≥4.12 mmol/L；
- •4.甘油三酯（triglyceride，TAG）≥2.25 mmol/L；
- •5.空腹血糖≥6.1 mmol/L；
- •6.在过去的一年里体重的变化超过自身体重的 10%；
- •7.每日能量摄入与推荐相比摄入过高或者过低；
- •8.不愿意为试验调整饮食习惯或者本身有特殊的饮食要求；
- •9.在志愿者招募的过程中表现出较差的依从性或者不能很好地完成食物记录和问卷的填写；
- •10.饮食失调或精神上或时间安排上可能影响试验进行；
- •11.有过心血管疾病、糖尿病和癌症病史；
- •13.患有过内分泌、肺部或者血液病；
- •14.患有胃肠道疾病；
- •16.患有其他可能影响志愿者遵守试验规定的疾病；
- •17.现阶段正在服用可能影响糖脂代谢的补充剂或药品；
- •18.吸烟或者饮酒≥1 次 / 周；
- •19.目前或准备怀孕或者正在母乳喂养。
Arms & Interventions
对照组
大豆油
干预组 1
牡丹籽油
干预组 2
茶籽油
Outcomes
Primary Outcomes
血常规指标
红细胞膜脂肪酸谱
肠道菌群
粪便代谢组学
尿液代谢组学
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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