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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

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Dyslipidemias Dietary Supplement: Walnuts 30 grams Dietary Supplement: Walnuts 60 grams Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
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
Official Title: NUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)
Actual Study Start Date : October 14, 2019
Actual Primary Completion Date : July 30, 2020
Estimated Study Completion Date : December 2021

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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037943


Locations
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China, Ningxia
Yi Zhao
Yinchuan, Ningxia, China, 750004
Sponsors and Collaborators
The George Institute for Global Health, China
Ningxia Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The George Institute for Global Health, China
ClinicalTrials.gov Identifier: NCT04037943    
Other Study ID Numbers: NUTS
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The George Institute for Global Health, China:
Alpha linolenic acid
Additional relevant MeSH terms:
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Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases