Metabolic SyndromeNCT03237598
Gender Difference of Metabolic Syndrome and Its Association Between Dietary Diversity at Different Ages
An observational study of Metabolic Syndrome and Dietary Diversity, run by Nanjing Medical University.
Trial summary
With the development of economics in China, the dietary diversity got higher. Meanwhile, the prevalence of metabolic syndrome (MetS) raised up as well. To investigate the gender difference of getting MetS and its various associations with dietary diversity at different ages.Data of adults(n=4308) aged 18+ y with three… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Metabolic Syndrome, Dietary Diversity, Age
- How many people
- 4,308 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: Finally, 4308 participants were included in the present study, of which 2348 are female, and 1960 are male.
Who may be able to join
- In the present study, participants were extracted from 2009, as the biochemical data was only available in 2009. Only adults (≥18 years old) with complete information on food consumption and biochemical data were included in our analysis (n=5118).
Who cannot join
- We excluded women who were pregnant or lactating (n=41). To avoided the distortion of outlier, adults with implausible daily energy intake (>7000kcal or <520kcal) were censored (n=4). Meanwhile, adults who have a history of metabolic related disease, such as myocardial infarction (n=15), diabetes (n=90), and apoplexy (n=31) were excluded, because their diet might be changed after diagnostic disease. In addition, we also excluded people who take antihypertensive drugs (n=507). After matching food data with biochemical and anthropometric data and biochemical data, individuals with incomplete information was removed (n=122).
About this study
Official title: China Nutrition and Health Survey
With the development of economics in China, the dietary diversity got higher. Meanwhile, the prevalence of metabolic syndrome (MetS) raised up as well. To investigate the gender difference of getting MetS and its various associations with dietary diversity at different ages.Data of adults(n=4308) aged 18+ y with three consecutive 24-h recalls and complete co-variates information were extracted from Chinese Nutrition and Health Survey in 2009. Modified Dietary Diversity Score (DDS) was adopted to capture the diversity of diet. MetS was defined by the harmonized criteria. Multivariable adjusted logistic regression was carried out to detect the association between DDS and MetS and its components for young, middle aged and elderly adults by a cross-sectional study.
More detailed information can be found in Pubmed,PMID: 24341753 (The China Health and Nutrition Survey, 1989-2011.).
Read the detailed description
Population and data collection Chinese Nutrition and Health Survey (CHNS) was implemented by the University of North Carolina at Chapel Hill (UNC-CH) and the Chinese Institute of Nutrition and Food Safety (INFS), and China Center for Disease Control and Prevention (CCDC). This survey was approved by the Institutional Review Board of aforementioned institutions. All participants provided the written informed consent. Detailed information about this survey and laboratory examinations has been described elsewhere .
Dietary assessment and dietary diversity score Individual daily food consumption data were collected through face-to-face interviews for 3 consecutive days which are randomly distributed within one week. Trained field interviewers helped each participants recall the food that they consumed at home and outside in a 24-h period and recorded the codes (listed in the Food Composition Table of China), types, amounts, and locations of consumption for each food item by using food models and pictures. More detailed information about the dietary data in CHNS has been previously reported (The China Health and Nutrition Survey, 1989-2011,PMID: 24341753 .).
In line with previous studies, the investigator combine the original 12 major food categories in Chinese Food Composition Table into 6 broad groups (grains, vegetables, fruits, meat/poultry/seafood, dairy, and beans/eggs/nuts) based on similarities in nutrient composition and dietary function. Detailed information about DDS has been depicted in previous study(PMID: 27848939). Foods consumed less than a minimum amount (25g) per day was excluded to avoid measurement error caused by negligible consumption. Since the consumption of dairy was generally low in Chinese dietary, the cutoff point was adjusted to 10g per day. The DDS value ranges from 0 to 6 and higher value indicates greater diversity of diet.
Outcome variables and covariates Waist circumference was measured around the body at the top of the hipbone, using an unstretched tape over the light cloth. Measurement was conducted without putting any pressure to body surface, and the value was recorded to the nearest 0.1cm.Height and weight was measured by trained health worker using regularly calibrated equipments under the instructions of manufacturers. BMI was calculated by dividing the weight (kg) by the square of the height (m2). Blood pressure was measured after thrice rest in a seated position, each rest lasts for 5 minutes. It was utilized to calculate the average value of systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood sample was collected after 12-14h overnight fasting from all participants, and was stored in vacationer tubes. All blood samples were analyzed in the central laboratories of China-Japan Friendship Hospital. Fasting plasma glucose was measured by glucose oxidase-3'-phosphoadenosine 5'-phosphate (GOD-PAP), using the kit produced by Randox, United Kingdom (UK). Serum high-density lipoprotein cholesterol (HDL-C) concentration was measured by enzymatic method; serum triglyceride levels was measured by cholesterol oxidase peroxidase - 3'-phosphoadenosine 5'-phosphate (CHOD-PAP); these two testing reagent were produced by the Kyowa, Japan. The last three indices were measured by the Hitachi 7600 machine. Detailed information about blood collection and test are presented in appendix 1.
Information about sex, age, income per capita, and educational level (Primary, middle and high) can be found in previous study, total energy intake, smoking status (0= currently not smoking, 1= currently smoking) and drinking status (0= did not drink in the past year, 1= drank alcohol in the past year), and residential area (urban and rural, north and south) were collected as co-variables. Physical activity was defined according to occupation (1=light physical activity, working in a sitting or standing position, such as office worker, teacher; 2=moderate physical activity, such as student or driver; 3= heavy physical activity, such as farmers, loader, miner), and adjusted in the model as well. Adults were categorized into three age groups according to the World Health Organization (WHO) standards (young: ≥18 \& ≤45; adult: >45 \& ≤60; old: >60).
Statistical analysis First, in order to investigate whether the association between dietary diversity and MetS varies between men and women, an interaction term between sex and DDS was added into the multivariable linear model. Accordingly, the descriptive statistical were presented at each tertiles of DDS for each sex(1st, ≤3; 2nd, 4; 3rd, 5-6). Continuous variates are presented as means ± standard deviations and categorical variables are presented as percentages.
The association between DDS and MetS and its individual components was detected by multivariable-adjusted logistic regression, both the OR values and 95% CI were presented. Sex, income per capita, educational level, physical activity, age and age squared, smoking and drinking status, fat share, total energy intake, and residential location were adjusted in the multivariable regression model. Income and total energy intake were measured in logarithm. The association between predicted probability of MetS and age was mapped using kernel weighted local polynomial smoothing; both the fitted probability and 95% confidence interval were presented. The linear trend of odds ratio for DDS was tested by taking DDS as continuous variable in the multivariable logistic regression.
All analyses were performed with Stata multi processing (MP) 13.0 (Stata Crop, USA) and P<0.05 was considered as statistical significance.
- Conditions
- Metabolic Syndrome, Dietary Diversity, Age
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| male | young (≥18 and ≤45), adult (45~60), and old (>60) , n=1960 | |
| female | young (≥18 and ≤45), adult (45~60), and old (>60) , n=2348 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome
MetS was defined according to the harmonized definition of the International Diabetes Federation and other organizations , that three or more out of five following criteria are considered as MetS: (1) central adiposity (WC >102 cm in men and >88cm in women); (2) serum HDL-C < 50 mg/dL in women or < 40 mg/dL in men; (3) serum triglyceride levels > 150 mg/dL; (4) SBP ≥ 130mm Hg or DBP ≥ 85mm Hg; (5) fasting plasma glucose ≥100 mg/dL.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Jan 2009
- Primary completion31 Dec 2009
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 4,308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Wang, Nanjing Medical University
- Investigators
- Hui Wang, Dr, Principal investigator, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237598
- Sponsor's protocol ID
- DDS and MetS
- Status last verified
- Aug 2017
- First submitted
- 26 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The bio-marker data is confidential, researchers need to apply for the analysis.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Nutrition and Health Survey
- ClinicalTrials.gov ID
- NCT03237598
- Acronym / sponsor ID
- DDS and MetS
- Conditions
- Metabolic Syndrome, Dietary Diversity, Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,308 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2009 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the development of economics in China, the dietary diversity got higher. Meanwhile, the prevalence of metabolic syndrome (MetS) raised up as well. To investigate the gender difference of getting MetS and its various associations with dietary diversity at different ages.Data of adults(n=4308) aged 18+ y with three consecutive 24-h recalls and complete co-variates information were extracted from Chinese Nutrition and Health Survey in 2009. Modified Dietary Diversity Score (DDS) was adopted to capture the diversity of diet. MetS was defined by the harmonized criteria. Multivariable adjusted logistic regression was carried out to detect the association between DDS and MetS and its components for young, middle aged and elderly adults by a cross-sectional study.
More detailed information can be found in Pubmed,PMID: 24341753 (The China Health and Nutrition Survey, 1989-2011.).
Detailed description
Population and data collection Chinese Nutrition and Health Survey (CHNS) was implemented by the University of North Carolina at Chapel Hill (UNC-CH) and the Chinese Institute of Nutrition and Food Safety (INFS), and China Center for Disease Control and Prevention (CCDC). This survey was approved by the Institutional Review Board of aforementioned institutions. All participants provided the written informed consent. Detailed information about this survey and laboratory examinations has been described elsewhere .
Dietary assessment and dietary diversity score Individual daily food consumption data were collected through face-to-face interviews for 3 consecutive days which are randomly distributed within one week. Trained field interviewers helped each participants recall the food that they consumed at home and outside in a 24-h period and recorded the codes (listed in the Food Composition Table of China), types, amounts, and locations of consumption for each food item by using food models and pictures. More detailed information about the dietary data in CHNS has been previously reported (The China Health and Nutrition Survey, 1989-2011,PMID: 24341753 .).
In line with previous studies, the investigator combine the original 12 major food categories in Chinese Food Composition Table into 6 broad groups (grains, vegetables, fruits, meat/poultry/seafood, dairy, and beans/eggs/nuts) based on similarities in nutrient composition and dietary function. Detailed information about DDS has been depicted in previous study(PMID: 27848939). Foods consumed less than a minimum amount (25g) per day was excluded to avoid measurement error caused by negligible consumption. Since the consumption of dairy was generally low in Chinese dietary, the cutoff point was adjusted to 10g per day. The DDS value ranges from 0 to 6 and higher value indicates greater diversity of diet.
Outcome variables and covariates Waist circumference was measured around the body at the top of the hipbone, using an unstretched tape over the light cloth. Measurement was conducted without putting any pressure to body surface, and the value was recorded to the nearest 0.1cm.Height and weight was measured by trained health worker using regularly calibrated equipments under the instructions of manufacturers. BMI was calculated by dividing the weight (kg) by the square of the height (m2). Blood pressure was measured after thrice rest in a seated position, each rest lasts for 5 minutes. It was utilized to calculate the average value of systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood sample was collected after 12-14h overnight fasting from all participants, and was stored in vacationer tubes. All blood samples were analyzed in the central laboratories of China-Japan Friendship Hospital. Fasting plasma glucose was measured by glucose oxidase-3'-phosphoadenosine 5'-phosphate (GOD-PAP), using the kit produced by Randox, United Kingdom (UK). Serum high-density lipoprotein cholesterol (HDL-C) concentration was measured by enzymatic method; serum triglyceride levels was measured by cholesterol oxidase peroxidase - 3'-phosphoadenosine 5'-phosphate (CHOD-PAP); these two testing reagent were produced by the Kyowa, Japan. The last three indices were measured by the Hitachi 7600 machine. Detailed information about blood collection and test are presented in appendix 1.
Information about sex, age, income per capita, and educational level (Primary, middle and high) can be found in previous study, total energy intake, smoking status (0= currently not smoking, 1= currently smoking) and drinking status (0= did not drink in the past year, 1= drank alcohol in the past year), and residential area (urban and rural, north and south) were collected as co-variables. Physical activity was defined according to occupation (1=light physical activity, working in a sitting or standing position, such as office worker, teacher; 2=moderate physical activity, such as student or driver; 3= heavy physical activity, such as farmers, loader, miner), and adjusted in the model as well. Adults were categorized into three age groups according to the World Health Organization (WHO) standards (young: ≥18 \& ≤45; adult: >45 \& ≤60; old: >60).
Statistical analysis First, in order to investigate whether the association between dietary diversity and MetS varies between men and women, an interaction term between sex and DDS was added into the multivariable linear model. Accordingly, the descriptive statistical were presented at each tertiles of DDS for each sex(1st, ≤3; 2nd, 4; 3rd, 5-6). Continuous variates are presented as means ± standard deviations and categorical variables are presented as percentages.
The association between DDS and MetS and its individual components was detected by multivariable-adjusted logistic regression, both the OR values and 95% CI were presented. Sex, income per capita, educational level, physical activity, age and age squared, smoking and drinking status, fat share, total energy intake, and residential location were adjusted in the multivariable regression model. Income and total energy intake were measured in logarithm. The association between predicted probability of MetS and age was mapped using kernel weighted local polynomial smoothing; both the fitted probability and 95% confidence interval were presented. The linear trend of odds ratio for DDS was tested by taking DDS as continuous variable in the multivariable logistic regression.
All analyses were performed with Stata multi processing (MP) 13.0 (Stata Crop, USA) and P<0.05 was considered as statistical significance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| male | – | –young (≥18 and ≤45), adult (45~60), and old (>60) , n=1960 |
| female | – | –young (≥18 and ≤45), adult (45~60), and old (>60) , n=2348 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Finally, 4308 participants were included in the present study, of which 2348 are female, and 1960 are male.
Key inclusion criteria (1 listed)
- In the present study, participants were extracted from 2009, as the biochemical data was only available in 2009. Only adults (≥18 years old) with complete information on food consumption and biochemical data were included in our analysis (n=5118).
Key exclusion criteria (1 listed)
- We excluded women who were pregnant or lactating (n=41). To avoided the distortion of outlier, adults with implausible daily energy intake (>7000kcal or <520kcal) were censored (n=4). Meanwhile, adults who have a history of metabolic related disease, such as myocardial infarction (n=15), diabetes (n=90), and apoplexy (n=31) were excluded, because their diet might be changed after diagnostic disease. In addition, we also excluded people who take antihypertensive drugs (n=507). After matching food data with biochemical and anthropometric data and biochemical data, individuals with incomplete information was removed (n=122).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | female, male |
Primary outcome
Metabolic syndrome
Time frame: through study completion, an average of 1 year
MetS was defined according to the harmonized definition of the International Diabetes Federation and other organizations , that three or more out of five following criteria are considered as MetS: (1) central adiposity (WC >102 cm in men and >88cm in women); (2) serum HDL-C < 50 mg/dL in women or < 40 mg/dL in men; (3) serum triglyceride levels > 150 mg/dL; (4) SBP ≥ 130mm Hg or DBP ≥ 85mm Hg; (5) fasting plasma glucose ≥100 mg/dL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Individual participant dataSharing planned: No. The bio-marker data is confidential, researchers need to apply for the analysis.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Wang, Dr principal investigator
Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Dietary Diversity, run by Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.