NUTS for the Prevention of Cardiovascular Disease in Chinese Adults

NCT04037943 | Completed

• 1 other identifier: NUTS
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Dyslipidemias

Keywords

Alpha linolenic acid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Post-intervention differences in estimated dietary nuts intake from 24h dietary recall between groups

  From baseline to 6 months

• Differences in adherence and acceptability of walnuts between the high and low dose groups

  From 2 week, 12 weeks to 6 months

Other Outcomes (6)

• Post-intervention differences in plasma total triglycerides between groups

  From baseline to 6 months

• Post-intervention differences in plasma total cholesterol between groups

  From baseline to 6 months

• Post-intervention differences in plasma HDL- cholesterol between groups

  From baseline to 6 months

Study Arms (3)

Low-dose group

EXPERIMENTAL

Low-dose group will received 30 grams of walnuts everyday during the study period of 6 months.

Dietary Supplement: Walnuts 30 grams

High-dose group

EXPERIMENTAL

High-dose group will received 60 grams of walnuts everyday during the study period of 6 months.

Dietary Supplement: Walnuts 60 grams

Control group

NO INTERVENTION

Control group will received non-edible gifts during the study period of 6 months.

Interventions

Walnuts 30 grams DIETARY_SUPPLEMENT

Roasted walnuts without salt or sugar.

Low-dose group

Walnuts 60 grams DIETARY_SUPPLEMENT

Roasted walnuts without salt or sugar.

High-dose group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The George Institute for Global Health, China: lead
• Ningxia Medical University: collaborator

Study Sites (1)

Yi Zhao

Yinchuan, Ningxia, 750004, China

Location

Related Publications (1)

• 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.

  PMID: 33407490 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is a single-blinded trial where investigators and outcome assessors will be blinded to the groups the participants are randomized to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: July 30, 2019
• Study Start: October 14, 2019
• Primary Completion: July 30, 2020
• Study Completion: December 24, 2021
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

CN (1)