NUTS: NUTS for the prevention of cardiovascular disease in Chinese adults
Nuts have long been seen as a type of food that reduces risks of cardiovascular disease. However, as the conclusion that “nuts are good for health” is widely derived from observational studies, it is not clear whether increasing nuts intake can prevent serious cardiovascular disease events, like stroke and heart attack. Therefore, large-scale randomized controlled trials are critically needed; of which NUTS has been designed to assess the feasibility of such a clinical trial in China.
The pilot study will be conducted in six rural areas of the Ningxia Hui Autonomous Region, where the plan is to recruit 210 patients at high-risk for cardiovascular disease. Subjects were randomly assigned to a low-dose group (30 grams of walnuts per day), high-dose group (60 grams of walnuts per day), or control group (blank control) on a 1:1:1 ratio. The study will last six months, and researchers will collect fasting blood samples from all subjects at both baseline and 6 months. Follow-up visits will be conducted at 2 weeks, and 3 and 6 months after commencement of the intervention. The main outcome indicators of the study will be levels of plasma linoleic acid (a biomarker that reflects walnut intake); the secondary outcome indicators will include the subjects' self-reported acceptance of walnut supplements and changes in subjects' weight; and the exploratory outcome indicators of plasma lipid levels and blood sugar.