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

NCT03882645 | Terminated DMC

• 1 other identifier: 2016YFC1300201
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Chinese Heart Healthy Diet; Randomized Controlled Trial; Feeding Study; Blood Pressure; serum lipids; Fasting Blood Glucose; Diet Modification

Outcome Measures

Primary Outcomes (1)

• The change on systolic blood pressure among people at high risk of cardiovascular and cerebrovascular diseases

  Changes of systolic blood pressure in CHH-diet group compared with changes of usual diet group. Blood pressure will be taken 3 times within 24 hours at baseline and at the end of this trial: one in the morning between 8:00 am to 10:00 am, one in the afternoon between 2:00 pm to 4:00 pm, and one in the evening between 6:00 pm to 8:00 pm, respectively. In each time, 3 readings should be taken with at least one minute intervals. The mean of nine SBP readings will be used for the calculation of the changes in each participant.

  before and after 4-week intervention

Secondary Outcomes (6)

• The change on the diastolic blood pressure among people at high risk of cardiovascular and cerebrovascular diseases

  before and after 4-week intervention

• The change on the serum total cholesterol among people at high risk of cardiovascular and cerebrovascular diseases

  before and after 4-week intervention

• The change on the fasting blood glucose among people at high risk of cardiovascular and cerebrovascular diseases

  before and after 4-week intervention

• The change on 10-year CVD risk among people at high risk of cardiovascular and cerebrovascular diseases

  before and after 4-week intervention

• The change on food preference scores among people at high risk of cardiovascular and cerebrovascular diseases

  before and after 4-week intervention

Other Outcomes (4)

• Dietary patterns analysis

  up to 5 weeks (1 week run-in and 4 weeks intervention)

• The change on the serum LDL-C among people at high risk of cardiovascular and cerebrovascular diseases

  before and after 4-week intervention

• The change on the serum HDL-C among people at high risk of cardiovascular and cerebrovascular diseases

  before and after 4-week intervention

Study Arms (2)

CHH-diet arm

EXPERIMENTAL

During the 4-week intervention period, free meals conformed to CHH-diet will be provided 3 times per daily (breakfast, lunch, dinner). Different center offers different meals of different cuisines but all conformed to "CHH-diet". The main nutrientional "healthy" goal of different cuisines will be achieved through specific nutrient targets, including fat, carbohydrate, protein, dietary fiber, sodium, potassium, magnesium and calcium.

Other: CHH-diet

local usual diet arm

OTHER

During the 4-week intervention period, three meals per day (breakfast, lunch, dinner) will be provided free of charge in line with local dietary characteristics. The energy,protein, carbohydrate, as week as dietary fiber, sodium, calcium, magnesium and potassium will be kept the same as that in the run-in phase.

Other: local usual diet

Interventions

CHH-diet OTHER

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.

CHH-diet arm

local usual diet OTHER

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

local usual diet arm

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged between 25 and 75 years old.
• Systolic blood pressure (SBP) in 130-159 mm Hg, regardless of medication use;
• Living in this community for the past six months and without intention to move out or go out in the next three months.
• Agree to keep the current drugs and their dosages unchanged throughout the study.
• Promised to follow the study diets for 5 weeks, and eat at least 18 study meals per week.
• Able to eat at least one meal per day at local research center.
• Signed Informed consent.

You may not qualify if:

• Fasting blood glucose ≥10.0 mmol/L.
• Total cholesterol ≥7.2 mmol/L.
• Any changes in dose and/or type of oral medication for antihypertensive, hypoglycemic or lipid-lowering in the past 3 months.
• Insulin injection within 1 month.
• Unable or unwilling to change diet for any reason (such as vegetarians).
• Relatives of researchers or administrators.
• Family members already in this study.
• Alcohol consumption ≥ 8 drinks per week for women, ≥15 drinks per week for men.
• BMI ≥ 30Kg/m2, or currently losing weight.
• Acute cardiovascular and cerebrovascular events within the past 6 months.
• A history of chronic kidney disease, intestinal irritation or asthma.
• Current or planned pregnancy prior to end of study, or breast-feeding.
• Other serious chronic disease thought to interfere with the effect of the diet or with participation, such as tumor, chronic heart failure, severe depression or other mental disorders, immobilization or unable to move freely.
• Allergy of common food (e.g. eggs, seafood, peanuts, etc.).
• On special diet due to medical needs.

Sponsors & Collaborators

• Peking University: lead
• Sun Yat-sen University: collaborator
• Sichuan University: collaborator
• Huadong Hospital: collaborator
• Yangzhou University: collaborator
• Centers for Disease Control and Prevention, China: collaborator

Study Sites (6)

Peking University

Beijing, Beijing Municipality, China

Location

Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Peking University Clinical Research Institute

Qingdao, Shandong, China

Location

Huadong Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Sichuan University

Chengdu, Sichuan, China

Location

Peking Univeristy Clinical Research Institute

Beijing, string:China, 100038, China

Location

Related Publications (3)

• Xie W, Wang Y, Sun J, Zeng G, Zhu H, Yang Z, Gao P, Yang J, Feng L, Lin PH, Li M, Xu J, Chen J, Wu Y. Protocol of a multicenter, single-blind, randomised, parallel controlled feeding trial evaluating the effect of a Chinese Healthy Heart (CHH) diet in lowering blood pressure and other cardiovascular risk factors. BMJ Open. 2020 Aug 20;10(8):e036394. doi: 10.1136/bmjopen-2019-036394.

  PMID: 32819944 BACKGROUND

• Wang Y, Feng L, Zeng G, Zhu H, Sun J, Gao P, Yuan J, Lan X, Li S, Zhao Y, Chen X, Dong H, Chen S, Li Z, Zhu Y, Li M, Li X, Yang Z, Li H, Fang H, Xie G, Lin PH, Chen J, Wu Y; DECIDE-Diet Study Group. Effects of Cuisine-Based Chinese Heart-Healthy Diet in Lowering Blood Pressure Among Adults in China: Multicenter, Single-Blind, Randomized, Parallel Controlled Feeding Trial. Circulation. 2022 Jul 26;146(4):303-315. doi: 10.1161/CIRCULATIONAHA.122.059045. Epub 2022 Jul 11.

  PMID: 35861850 BACKGROUND

• Li Q, Feng L, Sun J, Zhu H, Zeng G, Gao P, Yuan J, Zhao Y, Li S, Lan X, Chen X, Li Z, Chen S, Dong H, Li M, Li X, Yang Z, Li H, Xie G, Wang Z, Lin PH, Chen J, Wang Y, Wu Y; DECIDE-Diet Study Group includes the following; Study Management Committee; Study Advisory Committee; Participating centers and staff information. Effects of Chinese heart-healthy diet on blood lipids, glucose, and estimated 10-y cardiovascular disease risk among Chinese adults: results on secondary outcomes of a randomized controlled trial. Am J Clin Nutr. 2024 Feb;119(2):333-343. doi: 10.1016/j.ajcnut.2023.12.008. Epub 2023 Dec 16.

  PMID: 38110039 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Yanfang Wang

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of dietary intervention, it is impractical to blind the cook, dietitian and the study staff who are responsible for preparing the foods and taking all measurements of the diets. However, staffs conducting the outcome assessments will be blinded to the allocation of intervention assignments. In addition, every effort is made to blind the study participants to their intervention assignment. First, they will not be told of their group assignment. Second, the two groups will consume their meals in separate rooms. Third, the same dishes using similar food materials will be used for both groups at the same meal.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multi-center, randomized, single-blind, parallel controlled intervention is proposed in this study. 360 subjects are anticipated to be enrolled from each research centers (Qingdao and Beijing, Shanghai, Guangzhou, Chengdu). After the one-week run-in period baseline information of eligible participants will be collected. Then the subjects will be allocated to intervention group or control group through central randomization. Subjects in intervention group will be given free CHH-Diet for four weeks, while the subjects in the control group will be given free usual diet conforming to local characteristics for four week.

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: March 22, 2019
• Primary Completion: January 31, 2021
• Study Completion: March 30, 2021
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)