NUTS for the Prevention of Cardiovascular Disease in Chinese Adults

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Dyslipidemias
• Interventions: Dietary Supplement: Walnuts 60 grams; Dietary Supplement: Walnuts 30 grams

• Registration Number: NCT04037943
• Lead Sponsor: The George Institute for Global Health, China

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.

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-07-28
• Study First Posted: 2019-07-30
• Study Start: 2019-10-14
• Primary Completion: 2020-07-30
• Study Completion: 2021-12-24
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose group	Walnuts 60 grams	High-dose group will received 60 grams of walnuts everyday during the study period of 6 months.
Low-dose group	Walnuts 30 grams	Low-dose group will received 30 grams of walnuts everyday during the study period of 6 months.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yi Zhao; 🇨🇳 Yinchuan, Ningxia, China