NCT04037943

NUTS for the Prevention of Cardiovascular Disease in Chinese Adults

NUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: The George Institute for Global Health, China · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases
• Dyslipidemias

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Walnuts 30 grams	Roasted walnuts without salt or sugar.
DIETARY_SUPPLEMENT	Walnuts 60 grams	Roasted walnuts without salt or sugar.

Timeline

• Start date: 2019-10-14
• Primary completion: 2020-07-30
• Completion: 2021-12-24
• First posted: 2019-07-30
• Last updated: 2022-08-09

Locations

1 site across 1 country: China