- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02791139
Association of Midlife Dietary and Lifestyle Factors on Cardiac Functional Changes in the Elderly (CardiacAging)
Study Overview
Status
Conditions
Detailed Description
This proposal will investigate how midlife factors in diet and lifestyle affect various aspects of cardiac structure and function related to ageing. The investigators plan to conduct the study among a sub-cohort of 600 participants from the Singapore Chinese Health Study. Comprehensive information on diet and lifestyle factors had been collected at recruitment and updated in two subsequent follow-up interviews. Candidate nutrition-related blood biomarkers such as vitamins D, homocysteine, fatty acids (short, medium and long-chain) and lipids (LDL, HDL, triglycerides) will be analyzed from samples obtained between 1999 and 2004. The investigators will study effects of smoking, alcohol consumption, sleep duration, physical activity and diet on cardiac ageing. The investigators will study overall dietary pattern, intake of specific items such as fatty acids, soy food, coffee and tea beverages, from validated food frequency questionnaires (FFQ), and nutrients from questionnaire information from this cohort previously obtained.
These nutrient and lifestyle factors will be studied individually, and for their joint or interactive effects on cardiac ageing measurements. Quantitative cardiac ageing-related outcome parameters describing cardiac mass, systolic and diastolic function, and vessel distensibility will be examined by cardiac magnetic resonance imaging. Maximum oxygen uptake (VO2 max) will be calculated based on age, gender, waist circumference, resting heart rate, and exercise habits. Body composition will be analysed by a body composition analyser machine onto which subjects stand on.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Su-Mei Angela Koh, MBBS
- Email: angela.koh.s.m@singhealth.com.sg
Study Locations
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-
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Singapore, Singapore, 169609
- Recruiting
- National Heart Centre Singapore
-
Contact:
- Angela Su-Mei Koh, MBBS
- Email: angela.koh.s.m@nhcs.com.sg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
600 ageing participants randomly chosen from a current pool of about 5290 surviving cohort participants in the Singapore Chinese Health Study will be recruited.
200 Healthy Volunteers control group
Description
Inclusion Criteria:
- Who were younger than 60 years at recruitment
- Had been interviewed at baseline and at the two follow-up interviews
- Had provided biospecimens for research previously before the age of 65 years (2000-2004)
- Who will be 65 years or older by 2013
Exclusion Criteria:
- Any known history of heart disease or stroke
- Anticipated life expectancy < 1 year
- Unable to provide written informed consent to participate in the study
- Patients with cancer
- Patients with chronic renal disease
- Any metallic implants
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
Healthy Volunteers will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imaging (CMRI) Echocardiography Tonometry Genetic Testing (Blood) Hand-Grip Strength Measurement Body Fat Mass Analysis
|
Cardiovascular MRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create heart images.
To measure heart chamber size, heart function, blood vessel size and blood vessel function.
These measurements will help us understand the type and severity of heart failure.
Tonometry is a noninvasive method to obtain arterial pressure waveform
The blood will be stored for genetic tests and development of cell lines to study genetic risks for aging related diseases and cardiovascular disease.
We will measure your hand grip strength using a standard hand dynamometer which is a portable meter that you will use your hands to press on.
Body composition will be analysed by a body composition analyser machine onto which you will have to stand on.
|
Ageing
Ageing cohort will undergo the following studying procedures: Cardiovascular Magnetic Resonance Imaging (CMRI) Echocardiography Tonometry Genetic Testing (Blood) Body Fat Mass Analysis |
Cardiovascular MRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create heart images.
To measure heart chamber size, heart function, blood vessel size and blood vessel function.
These measurements will help us understand the type and severity of heart failure.
Tonometry is a noninvasive method to obtain arterial pressure waveform
The blood will be stored for genetic tests and development of cell lines to study genetic risks for aging related diseases and cardiovascular disease.
Body composition will be analysed by a body composition analyser machine onto which you will have to stand on.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
First occurrence of cardiovascular event
Time Frame: 1 Year
|
1 Year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Su-Mei Angela Koh, MBBS, National Heart Centre Singapore
Publications and helpful links
General Publications
- Tan YH, Lim JP, Lim WS, Gao F, Teo LLY, Ewe SH, Keng BMH, Tan RS, Koh WP, Koh AS. Obesity in Older Adults and Associations with Cardiovascular Structure and Function. Obes Facts. 2022;15(3):336-343. doi: 10.1159/000521729. Epub 2022 Mar 4.
- Kovalik JP, Zhao X, Gao F, Leng S, Chow V, Chew H, Teo LLY, Tan RS, Ewe SH, Tan HC, Wee HN, Lee LS, Ching J, Keng BMH, Koh WP, Zhong L, Koh AS. Amino acid differences between diabetic older adults and non-diabetic older adults and their associations with cardiovascular function. J Mol Cell Cardiol. 2021 Sep;158:63-71. doi: 10.1016/j.yjmcc.2021.05.009. Epub 2021 May 24.
- Koh AS, Velmurugan B, Gao F, Tan RS, Wong JI, Teo LLY, Keng BMH, Chua SJM, Yuan JM, Koh WP, Cheung C. Value of soluble Urokinase plasminogen activator receptor over age as a biomarker of impaired myocardial relaxation. BMC Geriatr. 2017 Nov 28;17(1):275. doi: 10.1186/s12877-017-0668-0.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2014/628/C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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