NUTS for the Prevention of Cardiovascular Disease in Chinese Adults (NUTS)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Dyslipidemias
• Intervention / Treatment: Dietary supplement: Walnuts 30 grams; Dietary supplement: Walnuts 60 grams

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • Yi Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Post-intervention differences in blood glucose between groups	Blood glucose will be measured at baseline and 6 months.	From baseline to 6 months
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

Collaborators and Investigators

• Sponsor: The George Institute for Global Health, China
• Collaborators: Ningxia Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): December 24, 2021

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: July 28, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Alpha linolenic acid
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Cardiovascular Diseases; Dyslipidemias
• Other Study ID Numbers: NUTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No