Clinical trial NCT04037943: NUTS for the Prevention of Cardiovascular Disease in Chinese Adults
Official title: NUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Dyslipidemias
Keywords: Alpha linolenic acid
Lead sponsor: The George Institute for Global Health, China
Sponsor class: OTHER
Collaborators: name: Ningxia Medical University
First posted: 2019-07-30
Enrollment: 210
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a three-group parallel design trial. The paralele groups will be the control group, the low-dose intervention group, and the high-dose intervention group. Eligible participants will be randomly assigned to one of the three groups.
Primary purpose: PREVENTION

Brief summary: This study evaluates the feasibility of walnuts supplementation among population of high CVD risks over a period of 6 months. 70 participants will be controls receiving non-edible gifts. 70 participants will be given 30 grams of walnuts everyday and 70 participants will be given 60 grams of walnuts a day.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Post-intervention differences in blood plasma alpha linolenic acid between groups
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Post-intervention differences in estimated dietary nuts intake from 24h dietary recall between groups
timeFrame: From baseline to 6 months
measure: Differences in adherence and acceptability of walnuts between the high and low dose groups
timeFrame: From 2 week, 12 weeks to 6 months
Other outcomes:
measure: Post-intervention differences in plasma total triglycerides between groups
timeFrame: From baseline to 6 months
measure: Post-intervention differences in plasma total cholesterol between groups
timeFrame: From baseline to 6 months
measure: Post-intervention differences in plasma HDL- cholesterol between groups
timeFrame: From baseline to 6 months
measure: Post-intervention differences in plasma LDL- cholesterol between groups
timeFrame: From baseline to 6 months
measure: Post-intervention differences in blood glucose between groups
timeFrame: From baseline to 6 months
measure: Post-intervention differences in body weight between groups
timeFrame: From baseline to 6 months
Locations:
city: Yinchuan
country: China
facility: Yi Zhao
state: Ningxia
Study officials:
References:
citation: Liu Y, Li N, Yan N, Pan XF, Li Q, Micha R, Mozaffarian D, Huffman MD, Wang Y, Neal B, Tian M, Zhao Y, Wu JHY. Protocol for a randomized controlled trial to test the acceptability and adherence to 6-months of walnut supplementation in Chinese adults at high risk of cardiovascular disease. Nutr J. 2021 Jan 6;20(1):3. doi: 10.1186/s12937-020-00660-7.