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Trial record 1 of 1 for:    NCT04037943
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NUTS for the Prevention of Cardiovascular Disease in Chinese Adults (NUTS)

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ClinicalTrials.gov Identifier: NCT04037943
Recruitment Status : Active, not recruiting
First Posted : July 30, 2019
Last Update Posted : May 13, 2021
Sponsor:
Collaborator:
Ningxia Medical University
Information provided by (Responsible Party):
The George Institute for Global Health, China

Tracking Information
First Submitted Date  ICMJE January 14, 2019
First Posted Date  ICMJE July 30, 2019
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE October 14, 2019
Actual Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
Post-intervention differences in blood plasma alpha linolenic acid between groups [ Time Frame: From baseline to 6 months ]
Blood plasma alpha linolenic acid will be measured at baseline and 6 months (end of trial).
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2019)
Change in blood plasma alpha linolenic acid from baseline to 6 months [ Time Frame: From baseline to 6 months ]
Blood plasma alpha linolenic acid will measured at baseline and 6 months (end of trial).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
  • Post-intervention differences in estimated dietary nuts intake from 24h dietary recall between groups [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2019)
  • Change in estimated dietary food intake by food frequency table from baseline to 6 months [ Time Frame: From baseline to 6 months ]
    Using food frequency table to estimate dietary food intake at baseline and 6 months (end of trial).
  • Change in estimated dietary food intake by 24 hour dietary recall from baseline to 6 months [ Time Frame: From baseline to 6 months ]
    Using 24 hour dietary recall to estimate dietary food intake at baseline and 6 months (end of trial).
  • Change in body weight from baseline to 6 months [ Time Frame: From baseline to 6 months ]
    All participants' body weight will be measured at baseline and 6 months (end of trial) in kilograms.
Current Other Pre-specified Outcome Measures
 (submitted: July 9, 2020)
  • Post-intervention differences in plasma total triglycerides between groups [ Time Frame: From baseline to 6 months ]
    Plasma total triglycerides (mg/dL) will be measured at baseline and 6 months.
  • Post-intervention differences in plasma total cholesterol between groups [ Time Frame: From baseline to 6 months ]
    Plasma total cholesterol (mg/dL) will be measured at baseline and 6 months.
  • Post-intervention differences in plasma HDL- cholesterol between groups [ Time Frame: From baseline to 6 months ]
    Plasma HDL- cholesterol (mg/dL) will be measured at baseline and 6 months.
  • Post-intervention differences in plasma LDL- cholesterol between groups [ Time Frame: From baseline to 6 months ]
    Plasma LDL- cholesterol (mg/dL) will be measured at baseline and 6 months.
  • Post-intervention differences in blood glucose between groups [ Time Frame: From baseline to 6 months ]
    Blood glucose will be measured at baseline and 6 months.
  • Post-intervention differences in body weight between groups [ Time Frame: From baseline to 6 months ]
    All participants' body weight will be measured at baseline and 6 months (end of trial) in kilograms.
Original Other Pre-specified Outcome Measures
 (submitted: July 28, 2019)
  • Change in plasma total triglycerides from baseline to 6 months [ Time Frame: From baseline to 6 months ]
    Plasma total triglycerides (mg/dL) will be measured at baseline and 6 months.
  • Change in plasma total cholesterol from baseline to 6 months [ Time Frame: From baseline to 6 months ]
    Plasma total cholesterol (mg/dL) will be measured at baseline and 6 months.
  • Change in plasma HDL- cholesterol from baseline to 6 months [ Time Frame: From baseline to 6 months ]
    Plasma HDL- cholesterol (mg/dL) will be measured at baseline and 6 months.
  • Change in plasma LDL- cholesterol from baseline to 6 months [ Time Frame: From baseline to 6 months ]
    Plasma LDL- cholesterol (mg/dL) will be measured at baseline and 6 months.
  • Change in blood glucose from baseline to 6 months [ Time Frame: From baseline to 6 months ]
    Blood glucose will be measured at baseline and 6 months.
 
Descriptive Information
Brief Title  ICMJE NUTS for the Prevention of Cardiovascular Disease in Chinese Adults
Official Title  ICMJE NUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes 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.
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Diseases
  • Dyslipidemias
Intervention  ICMJE
  • Dietary Supplement: Walnuts 30 grams
    Roasted walnuts without salt or sugar.
  • Dietary Supplement: Walnuts 60 grams
    Roasted walnuts without salt or sugar.
Study Arms  ICMJE
  • Experimental: Low-dose group
    Low-dose group will received 30 grams of walnuts everyday during the study period of 6 months.
    Intervention: Dietary Supplement: Walnuts 30 grams
  • Experimental: High-dose group
    High-dose group will received 60 grams of walnuts everyday during the study period of 6 months.
    Intervention: Dietary Supplement: Walnuts 60 grams
  • No Intervention: Control group
    Control group will received non-edible gifts during the study period of 6 months.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2019)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Actual Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04037943
Other Study ID Numbers  ICMJE NUTS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party The George Institute for Global Health, China
Study Sponsor  ICMJE The George Institute for Global Health, China
Collaborators  ICMJE Ningxia Medical University
Investigators  ICMJE Not Provided
PRS Account The George Institute for Global Health, China
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP