Chinese Heart Healthy Diet for People With High Cardiovascular Risk in China (DECIDE-Diet)

Summary

The DECIDE - Diet (Diet, ExerCIse and carDiovascular hEalth - Chinese Heart Healthy Diet for People With High Cardiovascular Risk in China) is to evaluate the effects of CHH-diet in reducing blood pressure in Chinese people with high cardiovascular risk. The study will recruit 360 adults people from 4 centers in China. All eligible participants will participate in a 1-week run-in phase in which they are fed the usual Chinese diet. Participants who pass the run-in phase will be randomly assigned 1:1 to receive CHH-diet or usual diet with the use of a central concealed randomization procedure (simple randomization), stratified by center and batch.

The intervention will last 28 days. Primary outcome will be the change in systolic blood pressure. The secondary outcomes include the differences between the two groups in the changes of diastolic blood pressure, total cholesterol, fasting blood glucose, 10-year CVD risk, gut microbial community and food preference score.

Conditions

• Cardiovascular Disease
• Diet Modification
• Randomized Controlled Trial

Interventions

OTHER

CHH-diet

This study took the DASH Diet as the basic model and developed the "Chinese Heart Healthy Diet ( CHH-diet)" according to the principles in the "2016 Dietary Guidelines for Chinese Residents". The nutrients targets in CHH-diet are set as following: fat % of total kcal: 25-27% (saturated: 6%; monounsaturated: 12%; polyunsaturated: 8%); carbohydrate % of total kcal: 55-60%; protein % of total kcal: 17-19%; dietary fiber: 30 g/day; sodium: 3000 mg/day; potassium: 3700 mg/day; magnesium: 500 mg/day; calcium: 1200 mg/day. The total energy will be set according to how much participants are eating in run-in period.

OTHER

local usual diet

The nutrients targets and total energy in usual diet are set according to how much participants are eating in run-in period.

Sponsors & Collaborators

• Sun Yat-sen University

  collaborator OTHER

• Sichuan University

  collaborator OTHER

• Huadong Hospital

  collaborator OTHER

• Yangzhou University

  collaborator OTHER

• Centers for Disease Control and Prevention, China

  collaborator OTHER_GOV

• Peking University

  lead OTHER

Principal Investigators

• Yanfang Wang · Peking University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-22

Primary Completion

2021-01-31

Completion

2021-03-30

Countries

• China

Study Locations