Effects of n-3 Fatty Acids on Cognitive Function, Sleep Quality, and Bone Mineral Density in Diabetic Patients: an Ancillary Study of the Precision Nutritional Management for Diabetes (PNMD) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 415
- 试验地点
- 1
- 主要终点
- Bone mineral density
研究概览
简要总结
The Precision Nutritional Management for Diabetes trial (PNMD; NCT03708887) is a randomized clinical trial in 415 diabetic patients investigating whether taking daily dietary supplements of omega-3 fatty acids (1.5 or 3 grams) improves glucose and lipid homeostasis in Chinese diabetic patients. This ancillary study is being conducted among PNMD participants and will examine whether fish oil supplements affect A) cognitive function, B) sleep quality, and C) bone mineral density. Cognitive function, sleep quality, and bone mineral density will be evaluated at baseline and post-intervention. The Mini-Mental State Exams (MMSE) will be conducted to evaluate the cognitive function of participants. The Pittsburgh Sleep Quality Index (PSQI) will be calculated through questionnaires to evaluate sleep quality. The Dual-emission X-ray Absorptiometry (DXA) will be assessed to measure the bone density.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed type 2 diabetes according to WHO diagnostic criteria or those on the use of diabetic medications;
- •Between 40 and 75 years old (postmenopausal women);
- •Have never used n-3 PUFA supplements before or have stopped using them for more than six months.
排除标准
- •Type 1 diabetes;
- •Coronary heart disease, stroke, cancer, hepatic or kidney disease;
- •Pregnancy or lactation;
- •Allergy to fish;
- •Have participated in other clinical trials in the last three months.
结局指标
主要结局
Bone mineral density
时间窗: Baseline and 1 year
The Dual-emission X-ray Absorptiometry (DXA) will be assessed to measure the bone mineral density at baseline and post-intervention.
Sleep quality
时间窗: Baseline and 1 year
The Pittsburgh Sleep Quality Index (PSQI) will be calculated through questionnaires to evaluate sleep quality. The Changes in sleep quality will be quantified by the difference in PSQI scores between the baseline and the conclusion of the intervention period.
Cognitive function
时间窗: Baseline and 1 year
The Mini-Mental State Exams (MMSE) will be conducted to evaluate the cognitive function of participants at both the start and end of the study. Changes in cognitive function will be quantified by the difference in MMSE scores between the baseline and the conclusion of the intervention period.
次要结局
未报告次要终点
研究者
Jingjing Jiao
Professor
Zhejiang University