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Association of Midlife Dietary and Lifestyle Factors on Cardiac Functional Changes in the Elderly (CardiacAging)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02791139
Recruitment Status : Unknown
Verified May 2016 by National Heart Centre Singapore.
Recruitment status was:  Recruiting
First Posted : June 6, 2016
Last Update Posted : June 16, 2016
Sponsor:
Collaborator:
National University, Singapore
Information provided by (Responsible Party):
National Heart Centre Singapore

Brief Summary:
The investigators aim to investigate the association of midlife dietary and lifestyle factors on cardiac functional changes in the elderly. The investigators hypothesize that even in those without clinically manifest cardiovascular disease, the extent of underlying abnormalities in cardiovascular structure and function in the elderly would be independently related to midlife dietary and lifestyle factors.

Condition or disease Intervention/treatment
Ageing Other: Cardiovascular Magnetic Resonance Imaging (MRI) Other: Echocardiography Other: Tonometry Other: Genetic Testing (Blood) Other: Hand-Grip Strength Measurement Other: Body Fat Mass Analysis

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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Association of Midlife Dietary and Lifestyle Factors on Cardiac Functional Changes in the Elderly
Study Start Date : July 2014
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

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
Other: Cardiovascular Magnetic Resonance Imaging (MRI)
Cardiovascular MRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create heart images.

Other: Echocardiography
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.

Other: Tonometry
Tonometry is a noninvasive method to obtain arterial pressure waveform

Other: Genetic Testing (Blood)
The blood will be stored for genetic tests and development of cell lines to study genetic risks for aging related diseases and cardiovascular disease.

Other: Hand-Grip Strength Measurement
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.

Other: Body Fat Mass Analysis
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

Other: Cardiovascular Magnetic Resonance Imaging (MRI)
Cardiovascular MRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create heart images.

Other: Echocardiography
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.

Other: Tonometry
Tonometry is a noninvasive method to obtain arterial pressure waveform

Other: Genetic Testing (Blood)
The blood will be stored for genetic tests and development of cell lines to study genetic risks for aging related diseases and cardiovascular disease.

Other: Body Fat Mass Analysis
Body composition will be analysed by a body composition analyser machine onto which you will have to stand on.




Primary Outcome Measures :
  1. First occurrence of cardiovascular event [ Time Frame: 1 Year ]

Biospecimen Retention:   Samples With DNA
The blood will be stored for genetic tests and development of cell lines to study genetic risks for aging related diseases and cardiovascular disease.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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

Criteria

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

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): NCT02791139


Contacts
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Contact: Su-Mei Angela Koh, MBBS angela.koh.s.m@singhealth.com.sg

Locations
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Singapore
National Heart Centre Singapore Recruiting
Singapore, Singapore, 169609
Contact: Angela Su-Mei Koh, MBBS       angela.koh.s.m@nhcs.com.sg   
Sponsors and Collaborators
National Heart Centre Singapore
National University, Singapore
Investigators
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Principal Investigator: Su-Mei Angela Koh, MBBS National Heart Centre Singapore
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Heart Centre Singapore
ClinicalTrials.gov Identifier: NCT02791139    
Other Study ID Numbers: 2014/628/C
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No