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| Name | Class |
|---|---|
| Ningxia Medical University | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose group | Experimental | Low-dose group will received 30 grams of walnuts everyday during the study period of 6 months. |
|
| High-dose group | Experimental | High-dose group will received 60 grams of walnuts everyday during the study period of 6 months. |
|
| Control group | No Intervention | Control group will received non-edible gifts during the study period of 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walnuts 30 grams | Dietary Supplement | Roasted walnuts without salt or sugar. |
| |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
With at least two of the following risk factors:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yi Zhao | Yinchuan | Ningxia | 750004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33407490 | Derived | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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This study is a single-blinded trial where investigators and outcome assessors will be blinded to the groups the participants are randomized to.
| Walnuts 60 grams |
| Dietary Supplement |
Roasted walnuts without salt or sugar. |
|
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 |
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 |