NUTSNUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)
Walnuts 30 grams
+ Walnuts 60 grams
Cardiovascular Diseases+2
+ Metabolic Diseases
+ Nutritional and Metabolic Diseases
Prevention Study
Summary
Study start date: October 14, 2019
Actual date on which the first participant was enrolled.Increased consumption of nuts improves the levels of lipid risk factors associated with cardiovascular disease and consistently relates to lower risk of cardiovascular disease (CVD) in prospective cohort studies. The estimates of health effects and potential population benefits of increased consumption of nuts are based mostly on observational data and there remains considerable uncertainty about whether higher intake of nuts will actually reduce cardiovascular outcomes. To address this uncertainty will require a well-conducted, adequately powered, large-scale, randomised control trial that tests the causal relationship between nut intake and the risk of cardiovascular diseases. We hereby designed a 6-month walnut supplementation trial in a rural area of China with high rates of CVD, to obtain data to support and help to refine the design of a future long-term large RCT testing the effect of nut supplementation on CVD risk. The main objectives of the current trial are to assess the acceptability and adherence to two different doses of walnut supplementation (30 and 60 grams per day). The exploratory objectives are to determine the effects of walnut supplementation on cardiovascular risk factors including blood lipids, fasting glucose, and body weight.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.210 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. A history of CVD, defined on the basis of a prior hospitalisation for a myocardial infarction or stroke, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (with or without stenting), peripheral revascularization (angioplasty or surgery), symptomatic with documented hemodynamically-significant carotid or peripheral vascular disease, or amputation secondary to vascular disease, OR 2. Male aged \>60 years, or female aged\>65 years, AND With at least two of the following risk factors: 1. Type 2 diabetes requiring treatment with at least two oral anti-hyperglycaemic agents and/or insulin 2. Systolic blood pressure \> 140 mmHg while on one or more antihypertensive agents 3. Current daily smoking 4. Dyslipidaemia defined as HDL-cholesterol\<1.0mmol/L or LDL-cholesterol\>6.0mmol/L 5. Micro or macro albuminuria Exclusion Criteria: 1. Allergic to nuts (history of food allergy with hypersensitivity to any of the components of nuts) 2. Other serious medical condition that prevents nut consumption (e.g. digestive disease with fat intolerance) 3. Any medical condition thought to limit survival to less than 1 year 4. Difficulty with consuming nuts (e.g. dental health issues that prevent chewing walnuts) 5. Unwilling to consume nuts
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location