NUTS for the Prevention of Cardiovascular Disease in Chinese Adults

Cardiovascular Diseases Clinical Trial

— NUTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04037943
• Other study ID #: NUTS
• Status: Completed
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: December 24, 2021

Study information

• Verified date: August 2022
• Source: The George Institute for Global Health, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 24, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dyslipidemias

Intervention

Dietary Supplement:
• Walnuts 30 grams
Roasted walnuts without salt or sugar.
• Walnuts 60 grams
Roasted walnuts without salt or sugar.

Locations

Country	Name	City	State
China	Yi Zhao	Yinchuan	Ningxia

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute for Global Health, China	Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-intervention differences in plasma total triglycerides between groups	Plasma total triglycerides (mg/dL) will be measured at baseline and 6 months.	From baseline to 6 months
Other	Post-intervention differences in plasma total cholesterol between groups	Plasma total cholesterol (mg/dL) will be measured at baseline and 6 months.	From baseline to 6 months
Other	Post-intervention differences in plasma HDL- cholesterol between groups	Plasma HDL- cholesterol (mg/dL) will be measured at baseline and 6 months.	From baseline to 6 months
Other	Post-intervention differences in plasma LDL- cholesterol between groups	Plasma LDL- cholesterol (mg/dL) will be measured at baseline and 6 months.	From baseline to 6 months
Other	Post-intervention differences in blood glucose between groups	Blood glucose will be measured at baseline and 6 months.	From baseline to 6 months
Other	Post-intervention differences in body weight between groups	All participants' body weight will be measured at baseline and 6 months (end of trial) in kilograms.	From baseline to 6 months
Primary	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	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
Secondary	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