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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05337111
Other study ID # 2017-T1-002-036
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date July 31, 2020

Study information

Verified date April 2022
Source Nanyang Technological University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

South Asian men have lower cardiorespiratory fitness (CRF) than white men which is associated with a reduced capacity to oxidise fat during exercise. This is a risk factor for weight gain/regain. Whilst comparisons with Europeans are valuable, Asians are not a homogenous group and substantial differences in obesity and body fat partitioning exist with ethnicity. This cross-sectional pilot investigation aims to compare CRF and fat oxidation at rest and during exercise in Chinese, Indian and Malay men (from Singapore) with elevated BMI (23 -30 kg/m2). Forty-five men (15 each ethnicity) with elevated body mass index (23 -30 kg/m2) will complete testing in a fasted state on two separate mornings separated by ≥72 hours: (i) for a measure of CRF; and (ii) for a measure of fat oxidation at rest and during incremental exercise.


Description:

South Asian men have lower cardiorespiratory fitness (CRF) than white men which is associated with a reduced capacity to oxidise fat during exercise. This is a risk factor for weight gain/regain. Whilst comparisons with Europeans are valuable, Asians are not a homogenous group and substantial differences in obesity and body fat partitioning exist with ethnicity. This cross-sectional pilot investigation aims to compare CRF and fat oxidation at rest and during exercise in Chinese, Indian and Malay men (from Singapore) with elevated BMI (23 -30 kg/m2). Forty-five men (15 each ethnicity) with elevated body mass index (23 -30 kg/m2) will complete testing in a fasted state on two separate mornings separated by ≥72 hours: (i) for a measure of CRF; and (ii) for a measure of fat oxidation at rest and during incremental exercise. A submaximal exercise test will be used to estimate CRF (maximum oxygen uptake, VO2max) during walking using a standard protocol where subjects walk on a treadmill at 5 km/h with regular increments in gradient until individuals reach 80% of their estimated maximum heart rate [220 - age (years)]. Perceived exertion will be monitored assessed periodically during the test and expired gases continuously measured via a mouthpiece attached to an automated metabolic cart (Parvomedics MMS-2400; Parvomedics, Sandy, UT). Oxygen consumption will be extrapolated to estimate VO2max based on estimated maximum heart rate. Resting fat oxidation will be determined via a 30 minute measure of expired gases under a ventilated hood attached to an automated metabolic cart. Fat oxidation during exercise will be determined via walking on a treadmill with increments in speed and gradient until the respiratory exchange ratio is ≥ 0.95. Primary outcomes will be compared among groups and adjusted for any covariates (e.g., BMI, body fat percentage) as necessary.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date July 31, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years to 45 Years
Eligibility Inclusion Criteria: - male - age 25 - <45 years - Chinese, Indian or Malay based on self-identity for three generations (parents and grandparents) - BMI = 23 - < 30 kg/m2 and/or waist circumference = 90 cm - physically inactive defined as < 150 minutes moderate or < 75 minutes vigorous leisure-time physical activity per week, or the equivalent combination of both Exclusion Criteria: - females - personal history of cardio-metabolic diseases - dieting (i.e. restricting food/energy intake) - smokers - consuming alcohol > 3 times per week with > 3 drinks per time - using any medications which affect carbohydrate or lipid metabolism - any lower body injuries - fasting blood glucose > 6.1 mmol/L

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cardiorespiratory fitness test
Progressive submaximal exercise test on a treadmill to predict cardiorespiratory fitness
Resting measure of fat oxidation
Use of ventilated hood attached to automated metabolic cart to measure substrate oxidation at rest
Maximum fat oxidation test
Progressive exercise test to determine maximum fat oxidation during exercise

Locations

Country Name City State
Singapore Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University Singapore

Sponsors (2)

Lead Sponsor Collaborator
Nanyang Technological University Ministry of Education, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiorespiratory fitness Predicted measure of maximum oxygen uptake during exercise 1 day (Single measurement)
Primary Resting fat oxidation Measure of amount of fat oxidised whilst at rest in the postabsorptive (fasting) state 1 day (Single measurement)
Primary Maximum fat oxidation (exercise) Measure of maximum amount of fat oxidised whilst exercising in the postabsorptive state 1 day (Single measurement)
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