NUTS for the Prevention of Cardiovascular Disease in Chinese Adults (NUTS)
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| ClinicalTrials.gov Identifier: NCT04037943 |
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Recruitment Status :
Completed
First Posted : July 30, 2019
Last Update Posted : August 9, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Diseases Dyslipidemias | Dietary Supplement: Walnuts 30 grams Dietary Supplement: Walnuts 60 grams | Not Applicable |
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 (Clinical Trial) |
| Actual 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 |
| Actual Study Completion Date : | December 24, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Low-dose group
Low-dose group will received 30 grams of walnuts everyday during the study period of 6 months.
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Dietary Supplement: Walnuts 30 grams
Roasted walnuts without salt or sugar. |
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Experimental: High-dose group
High-dose group will received 60 grams of walnuts everyday during the study period of 6 months.
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Dietary Supplement: Walnuts 60 grams
Roasted walnuts without salt or sugar. |
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No Intervention: Control group
Control group will received non-edible gifts during the study period of 6 months.
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- 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).
- 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.
- 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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| China, Ningxia | |
| Yi Zhao | |
| Yinchuan, Ningxia, China, 750004 | |
| 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: | August 9, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Alpha linolenic acid |
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Cardiovascular Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |