Back to resultsNUTS for the Prevention of Cardiovascular Disease in Chinese Adults (NUTS)
Primary Purpose
Cardiovascular Diseases, Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Walnuts 30 grams
Walnuts 60 grams
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Alpha linolenic acid
Eligibility Criteria
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
Sites / Locations
- Yi Zhao
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Low-dose group
High-dose group
Control group
Arm Description
Low-dose group will received 30 grams of walnuts everyday during the study period of 6 months.
High-dose group will received 60 grams of walnuts everyday during the study period of 6 months.
Control group will received non-edible gifts during the study period of 6 months.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT04037943
First Posted
January 14, 2019
Last Updated
August 8, 2022
Sponsor
The George Institute for Global Health, China
Collaborators
Ningxia Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04037943
Brief Title
NUTS for the Prevention of Cardiovascular Disease in Chinese Adults
Acronym
NUTS
Official Title
NUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
December 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The George Institute for Global Health, China
Collaborators
Ningxia Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Dyslipidemias
Keywords
Alpha linolenic acid
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
This study is a single-blinded trial where investigators and outcome assessors will be blinded to the groups the participants are randomized to.
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-dose group
Arm Type
Experimental
Arm Description
Low-dose group will received 30 grams of walnuts everyday during the study period of 6 months.
Arm Title
High-dose group
Arm Type
Experimental
Arm Description
High-dose group will received 60 grams of walnuts everyday during the study period of 6 months.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will received non-edible gifts during the study period of 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Walnuts 30 grams
Intervention Description
Roasted walnuts without salt or sugar.
Intervention Type
Dietary Supplement
Intervention Name(s)
Walnuts 60 grams
Intervention Description
Roasted walnuts without salt or sugar.
Primary Outcome Measure Information:
Title
Post-intervention differences in blood plasma alpha linolenic acid between groups
Description
Blood plasma alpha linolenic acid will be measured at baseline and 6 months (end of trial).
Time Frame
From baseline to 6 months
Secondary Outcome Measure Information:
Title
Post-intervention differences in estimated dietary nuts intake from 24h dietary recall between groups
Description
Using 24 hour dietary recall to estimate dietary nuts intake at baseline and 6 months (end of trial).
Time Frame
From baseline to 6 months
Title
Differences in adherence and acceptability of walnuts between the high and low dose groups
Description
The adherence and acceptability of the supplement walnuts assessed by questionnaires conducted in the two intervention groups.
Time Frame
From 2 week, 12 weeks to 6 months
Other Pre-specified Outcome Measures:
Title
Post-intervention differences in plasma total triglycerides between groups
Description
Plasma total triglycerides (mg/dL) will be measured at baseline and 6 months.
Time Frame
From baseline to 6 months
Title
Post-intervention differences in plasma total cholesterol between groups
Description
Plasma total cholesterol (mg/dL) will be measured at baseline and 6 months.
Time Frame
From baseline to 6 months
Title
Post-intervention differences in plasma HDL- cholesterol between groups
Description
Plasma HDL- cholesterol (mg/dL) will be measured at baseline and 6 months.
Time Frame
From baseline to 6 months
Title
Post-intervention differences in plasma LDL- cholesterol between groups
Description
Plasma LDL- cholesterol (mg/dL) will be measured at baseline and 6 months.
Time Frame
From baseline to 6 months
Title
Post-intervention differences in blood glucose between groups
Description
Blood glucose will be measured at baseline and 6 months.
Time Frame
From baseline to 6 months
Title
Post-intervention differences in body weight between groups
Description
All participants' body weight will be measured at baseline and 6 months (end of trial) in kilograms.
Time Frame
From baseline to 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yi Zhao
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33407490
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.
Results Reference
derived
Learn more about this trial
NUTS for the Prevention of Cardiovascular Disease in Chinese Adults
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