NUTS for the Prevention of Cardiovascular Disease in Chinese Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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NUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)

Conditions
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Cardiovascular Diseases, Dyslipidemias

Intervention / Treatment
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* Dietary Supplement: Walnuts 30 grams
* Dietary Supplement: Walnuts 60 grams


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Male aged >60 years, or female aged>65 years, AND With at least two of the following risk factors: Type 2 diabetes requiring treatment with at least two oral anti-hyperglycaemic agents and/or insulin Systolic blood pressure > 140 mmHg while on one or more antihypertensive agents Current daily smoking Dyslipidaemia defined as HDL-cholesterol<1.0mmol/L or LDL-cholesterol>6.0mmol/L Micro or macro albuminuria Exclusion Criteria: Allergic to nuts (history of food allergy with hypersensitivity to any of the components of nuts) Other serious medical condition that prevents nut consumption (e.g. digestive disease with fat intolerance) Any medical condition thought to limit survival to less than 1 year Difficulty with consuming nuts (e.g. dental health issues that prevent chewing walnuts) Unwilling to consume nuts
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose group<br>Low-dose group will received 30 grams of walnuts everyday during the study period of 6 months. | Dietary Supplement: Walnuts 30 grams<br>* Roasted walnuts without salt or sugar.<br>|
| Experimental: High-dose group<br>High-dose group will received 60 grams of walnuts everyday during the study period of 6 months. | Dietary Supplement: Walnuts 60 grams<br>* Roasted walnuts without salt or sugar.<br>|
| No Intervention: Control group<br>Control group will received non-edible gifts during the study period of 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-intervention differences in blood plasma alpha linolenic acid between groups | Blood plasma alpha linolenic acid will be measured at baseline and 6 months (end of trial). | From baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-intervention differences in estimated dietary nuts intake from 24h dietary recall between groups | Using 24 hour dietary recall to estimate dietary nuts intake at baseline and 6 months (end of trial). | From baseline to 6 months | 
| Differences in adherence and acceptability of walnuts between the high and low dose groups | The adherence and acceptability of the supplement walnuts assessed by questionnaires conducted in the two intervention groups. | From 2 week, 12 weeks to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alpha linolenic acid