Fitness and Fat Oxidation in Overweight Chinese, Indian and Malay Men

April 19, 2022 updated by: Stephen Burns, Nanyang Technological University

Differences in Cardiorespiratory Fitness and Fat Oxidation at Rest and During Exercise in Chinese, Indian and Malay Men With Elevated Body Mass Index.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 637616
        • Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Healthy but physically inactive Chinese, Indian and Malay men aged 21-45 years with an elevated body mass index for Asians.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Chinese men
Chinese men based on self-identity for three generations (parents and grandparents), age 25 - <45 years, who are physically inactive (< 150 minutes moderate or < 75 minutes vigorous leisure-time physical activity per week), with elevated body mass index (>23-<30 kg/m2) for Asians. Single measure of CRF, resting fat oxidation and fat oxidation during graded exercise.
Other: Cardiorespiratory fitness test
Progressive submaximal exercise test on a treadmill to predict cardiorespiratory fitness
Other Names:
  • Graded exercise test, submaximal oxygen uptake test
Other: Resting measure of fat oxidation
Use of ventilated hood attached to automated metabolic cart to measure substrate oxidation at rest
Other Names:
  • Resting energy expenditure, resting substrate oxidation test
Other: Maximum fat oxidation test
Progressive exercise test to determine maximum fat oxidation during exercise
Indian men
Indian men based on self-identity for three generations (parents and grandparents), age 25 - <45 years, who are physically inactive (< 150 minutes moderate or < 75 minutes vigorous leisure-time physical activity per week), with elevated body mass index (>23-<30 kg/m2) for Asians. Single measure of CRF, resting fat oxidation and fat oxidation during graded exercise.
Other: Cardiorespiratory fitness test
Progressive submaximal exercise test on a treadmill to predict cardiorespiratory fitness
Other Names:
  • Graded exercise test, submaximal oxygen uptake test
Other: Resting measure of fat oxidation
Use of ventilated hood attached to automated metabolic cart to measure substrate oxidation at rest
Other Names:
  • Resting energy expenditure, resting substrate oxidation test
Other: Maximum fat oxidation test
Progressive exercise test to determine maximum fat oxidation during exercise
Malay men
Malay men based on self-identity for three generations (parents and grandparents), age 25 - <45 years, who are physically inactive (< 150 minutes moderate or < 75 minutes vigorous leisure-time physical activity per week), with elevated body mass index (>23-<30 kg/m2) for Asians. Single measure of CRF, resting fat oxidation and fat oxidation during graded exercise.
Other: Cardiorespiratory fitness test
Progressive submaximal exercise test on a treadmill to predict cardiorespiratory fitness
Other Names:
  • Graded exercise test, submaximal oxygen uptake test
Other: Resting measure of fat oxidation
Use of ventilated hood attached to automated metabolic cart to measure substrate oxidation at rest
Other Names:
  • Resting energy expenditure, resting substrate oxidation test
Other: Maximum fat oxidation test
Progressive exercise test to determine maximum fat oxidation during exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiorespiratory fitness
Time Frame: 1 day (Single measurement)
Predicted measure of maximum oxygen uptake during exercise
1 day (Single measurement)
Resting fat oxidation
Time Frame: 1 day (Single measurement)
Measure of amount of fat oxidised whilst at rest in the postabsorptive (fasting) state
1 day (Single measurement)
Maximum fat oxidation (exercise)
Time Frame: 1 day (Single measurement)
Measure of maximum amount of fat oxidised whilst exercising in the postabsorptive state
1 day (Single measurement)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanyang Technological University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Education, Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen F Burns, PhD, Nanyang Technological University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-T1-002-036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A copy of the anonymised data relating to this study will be made available in the Data Repository of the National Institute of Education (Singapore) after publication. Access to the data will be via reasonable request to the Principal Investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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