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

Ageing Clinical Trial

— CardiacAging  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02791139
• Other study ID #: 2014/628/C
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2016
• Last updated: June 14, 2016
• Start date: July 2014
• Est. completion date: April 2017

Study information

• Verified date: May 2016
• Source: National Heart Centre Singapore
• Contact: Su-Mei Angela Koh, MBBS
• Email: angela.koh.s.m[@]singhealth.com.sg
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ageing

Intervention

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.
• 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.
• Tonometry
Tonometry is a noninvasive method to obtain arterial pressure waveform
• 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.
• 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.
• Body Fat Mass Analysis
Body composition will be analysed by a body composition analyser machine onto which you will have to stand on.

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National Heart Centre Singapore	National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First occurrence of cardiovascular event		1 Year	No