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Trial record 85 of 92 for:    Recruiting, Not yet recruiting, Available Studies | "Cholesterol"

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

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ClinicalTrials.gov Identifier: NCT03882645
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : July 9, 2019
Sponsor:
Collaborators:
Sun Yat-sen University
Sichuan University
Huadong Hospital
Yangzhou University
Centers for Disease Control and Prevention, China
Information provided by (Responsible Party):
Yanfang Wang, Peking University

Brief Summary:

The DECIDE - Diet (Diet, ExerCIse and carDiovascular hEalth - China Heart Diet for People With High Cardiovascular Risk in China) is to evaluate the effects of China Heart 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 traditional Chinses diet. Participants who pass the run-in phase will be randomly assigned 1:1 to receive local China-Heart diet or traditional 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, 24-h urinary sodium, 10-year CVD risk, gut microbial gene richness, and microbiota composition.


Condition or disease Intervention/treatment Phase
Cardiovascular Disease Diet Modification Randomized Controlled Trial Other: China Heart Diet Other: traditional diet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center, randomized, single-blind, parallel controlled intervention is proposed in this study. 360 subjects are anticipated to be enrolled from four research centers (Qingdao, Shanghai, Guangzhou, Chengdu). After the one-week run-in period of traditional diet, we collect their baseline information and then the subjects will be allocated to intervention group or control group (traditional diet) through central randomization. Subjects in intervention group will be given free China Heart Diet for four weeks, while the subjects in the control group will be given free traditional Chinese diet conforming to local characteristics for four week.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Due to the nature of dietary intervention, it was impractical to blind kitchen staff and dietitian. Therefore, this is a single-blind trial, in which participants are not told which group they have been assign. In order to ensure blinding, the two groups will consume study foods in different rooms or floors on-site. Besides, outcome data collection personnel will also be blinded to the sequence of diets.
Primary Purpose: Prevention
Official Title: Diet, Exercise and Cardiovascular Health - Effects of China Heart Diet on Blood Pressure Among People With High Cardiovascular Risk: a Parallel, Multicenter, Single-blind, Randomized-feeding Controlled Trial
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: China Heart Diet arm
During the 4-week intervention period, free meals conformed to "China Heart Diet" will be provided 3 times per daily (breakfast, lunch, dinner). Different center offers different meals of different cuisines but all conformed to "China Heart Diet". The main "healthy" goal of different cuisines is achieved through specific dietary structure, including fat, carbohydrate, protein, dietary fiber, sodium, potassium, magnesium and calcium.
Other: China Heart Diet
This study took the DASH Diet as the basic model and developed a "China Heart Diet (CHD)" according to the principles in the "2016 dietary guidelines for Chinese residents". The nutrients compositions in CHD 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 mg/day; sodium: 3000 mg/day; potassium: 3700 mg/day; magnesium: 500 mg/day; calcium: 1200 mg/day. We will measure the actual intake of every meal for all subjects during 4-week intervention to better estimate their nutrients compositions. All subjects will be advised to avoid other food during the study period, and we collect the information of them if they eat.

traditional diet arm
During the 4-week intervention period, three meals per day (breakfast, lunch, dinner) were provided free of charge for four traditional Chinese meals (Shandong, Sichuan, Huaiyang or Cantonese) in line with local dietary characteristics. The main nutrients, dietary fiber, sodium, calcium, magnesium and potassium are set at the average dietary intake levels.
Other: traditional diet
The nutrients compositions in traditional diet are set as following: fat % of total kcal: 32-34% (saturated: 15%; monounsaturated: 11%; polyunsaturated: 7%); carbohydrate % of total kcal: 50-55%; protein % of total kcal: 10-12%; dietary fiber: 10.8 mg/day; sodium: 5700 mg/day; potassium: 1616 mg/day; magnesium: 330 mg/day; calcium: 366 mg/day. These sets mainly come from national nutrition survey. We will measure the actual intake of every meal for all subjects during 4-week intervention to better estimate their nutrients compositions. All subjects will be advised to avoid other food during the study period, and we collect the information of them if they eat.




Primary Outcome Measures :
  1. The effect on systolic blood pressure among people at high risk of cardiovascular and cerebrovascular diseases [ Time Frame: before and after 4-week intervention ]
    Changes of systolic blood pressure in CHD group compared with changes of traditional diet group. Subjects' systolic blood pressure will be measured by trained investigator according to standard operating procedure.


Secondary Outcome Measures :
  1. The effect on the diastolic blood pressure among people at high risk of cardiovascular and cerebrovascular diseases [ Time Frame: before and after 4-week intervention ]
    Changes of the diastolic blood pressure in CHD group compared with changes of traditional diet group. Subjects' diastolic blood pressure will be measured by trained investigator according to standard operating procedure.

  2. The effect on the total cholesterol among people at high risk of cardiovascular and cerebrovascular diseases [ Time Frame: before and after 4-week intervention ]
    Changes of the total cholesterol in CHD group compared with changes of traditional diet group. Subjects' total cholesterol will be tested by central lab using vein serum.

  3. The effect on the fasting blood glucose among people at high risk of cardiovascular and cerebrovascular diseases [ Time Frame: before and after 4-week intervention ]
    Changes of the fasting blood glucose in CHD group compared with changes of traditional diet group. Subjects' fasting blood glucose will be tested by central lab using vein serum.

  4. The effect on the 24-h urinary sodium among people at high risk of cardiovascular and cerebrovascular diseases [ Time Frame: before and after 4-week intervention ]
    Changes of the 24-h urinary sodium in CHD group compared with changes of traditional diet group. Subjects' urinary sodium will be tested by central lab using qualified second morning urine.

  5. The effect on the 10-year CVD risk among people at high risk of cardiovascular and cerebrovascular diseases [ Time Frame: before and after 4-week intervention ]
    Changes of the 10-year CVD risk in CHD group compared with changes of traditional diet group. Subjects' 10-year CVD risk will be calculated by published standardized questionnaire.

  6. The effect on subjects' gut microbial gene richness among people at high risk of cardiovascular and cerebrovascular diseases [ Time Frame: before and after 4-week intervention ]
    Changes of the gut microbial gene richness in CHD group compared with changes of traditional diet group.

  7. The effect on subjects' microbiota composition among people at high risk of cardiovascular and cerebrovascular diseases [ Time Frame: before and after 4-week intervention ]
    Changes of the microbiota composition in CHD group compared with changes of traditional diet group.



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women aged between 25 and 75 years old.
  2. Systolic blood pressure (SBP) in 130-159 mm Hg, regardless of medication use;
  3. Living in this community for the past six months and without intention to move out or go out in the next three months.
  4. Willing to agree to keep the current drugs and their dosages constant throughout the study.
  5. Willing to eat study diets and nothing else for 5 weeks, and agree to eat at least 18 study meals per week.
  6. Willing to eat at least one meal per day at local research center; or willing to eat at least one meal per week at local research center and agree to take pictures of any leftover food and send them to local research center.
  7. Signed Informed consent.

Exclusion Criteria:

  1. Fasting blood glucose ≥10.0 mmol/L.
  2. Total cholesterol ≥7.2 mmol/L.
  3. Any changes in dose and/or type of oral medication for antihypertensive, hypoglycemic or lipid-lowering in the past 3 months.
  4. Insulin injection within 1 month.
  5. Unwillingness or inability to change the original dietary pattern, or those with special dietary needs (such as vegetarians).
  6. Relatives of researchers or administrators.
  7. Family members already in this study.
  8. Alcohol consumption ≥ 8 drinks per week for women, ≥15 drinks per week for men.
  9. BMI ≥ 30Kg/m2, or currently losing weight.
  10. Acute cardiovascular and cerebrovascular events within the past 6 months.
  11. A history of chronic kidney disease, intestinal irritation or asthma.
  12. Current or planned pregnancy prior to end of study, or breast-feeding.
  13. 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.
  14. Allergy of common food (e.g. eggs, seafood, peanuts, etc.).
  15. A history of gastrointestinal surgery.
  16. Acute diseases such as upper respiratory tract infection, fever, severe diarrhea, etc.
  17. Deafness, dementia, and inability to communicate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882645


Contacts
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Contact: Yanfang Wang (+86)01082805831 ext 204 yanfang1225@gmail.com
Contact: Lin Feng 18611338647 april1022@163.com

Locations
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China, Shandong
Yanfang Wang Recruiting
Qingdao, Shandong, China
Contact: Yanfang Wang, PhD    18611338647 ext 18611338647    yanfang1225@gmail.com   
Contact: Lin Feng, PhD candidate       april1022@163.com   
China, Shanghai
Jianqin Sun Recruiting
Shanghai, Shanghai, China, 200000
Contact: Jianqin Sun, MD/PhD       jianqins@163.com   
Contact: Yanfang Zhao, MB       zyf17317821245@163.com   
Sponsors and Collaborators
Peking University
Sun Yat-sen University
Sichuan University
Huadong Hospital
Yangzhou University
Centers for Disease Control and Prevention, China
Investigators
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Principal Investigator: Yanfang Wang Peking University

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Responsible Party: Yanfang Wang, Professor, Peking University
ClinicalTrials.gov Identifier: NCT03882645     History of Changes
Other Study ID Numbers: 2016YFC1300201
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanfang Wang, Peking University:
China Heart Diet
Randomized Controlled Trial
Feeding Study
Blood Pressure
Cholesterol
Fasting Blood Glucose
Diet Modification
Additional relevant MeSH terms:
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Cardiovascular Diseases
Calcium, Dietary
Calcium
Nutrients
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Growth Substances