Overweight and ObesityNCT05337111
Fitness and Fat Oxidation in Overweight Chinese, Indian and Malay Men
An observational study of Overweight and Obesity, run by Nanyang Technological University at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Cardiorespiratory fitness test, Resting measure of fat oxidation and Maximum fat oxidation test
- How many people
- 45 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2019to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy but physically inactive Chinese, Indian and Malay men aged 21-45 years with an elevated body mass index for Asians.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University
Singapore, 637616
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Cardiorespiratory fitness test, Resting measure of fat oxidation, Maximum fat oxidation test
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiorespiratory fitness testOther
Also called Graded exercise test, submaximal oxygen uptake test
Progressive submaximal exercise test on a treadmill to predict cardiorespiratory fitness
Resting measure of fat oxidationOther
Also called Resting energy expenditure, resting substrate oxidation test
Use of ventilated hood attached to automated metabolic cart to measure substrate oxidation at rest
Maximum fat oxidation testOther
Progressive exercise test to determine maximum fat oxidation during exercise
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cardiorespiratory fitness test; Other: Resting measure of fat oxidation; Other: Maximum fat oxidation test | |
| 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. Receives: Other: Cardiorespiratory fitness test; Other: Resting measure of fat oxidation; Other: Maximum fat oxidation test | |
| 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. Receives: Other: Cardiorespiratory fitness test; Other: Resting measure of fat oxidation; Other: Maximum fat oxidation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
Predicted measure of maximum oxygen uptake during exercise
Measured: 1 day (Single measurement)
Resting fat oxidation
Measure of amount of fat oxidised whilst at rest in the postabsorptive (fasting) state
Measured: 1 day (Single measurement)
Maximum fat oxidation (exercise)
Measure of maximum amount of fat oxidised whilst exercising in the postabsorptive state
Measured: 1 day (Single measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Jul 2019
- Primary completion30 Mar 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Responsible party
- Principal investigator, Stephen Burns, Nanyang Technological University
- Investigators
- Stephen F Burns, PhD, Principal investigator, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337111
- Sponsor's protocol ID
- 2017-T1-002-036
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Demashkieh M, Dalan R, Burns SF. Cardiorespiratory fitness and fat oxidation during exercise in Chinese, Indian, and Malay men with elevated body mass index. Appl Physiol Nutr Metab. 2022 Aug 1;47(8):888-892. doi: 10.1139/apnm-2022-0106. Epub 2022 Jun 9.
PubMed 35679614
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Cardiorespiratory Fitness and Fat Oxidation at Rest and During Exercise in Chinese, Indian and Malay Men With Elevated Body Mass Index.
- ClinicalTrials.gov ID
- NCT05337111
- Acronym / sponsor ID
- 2017-T1-002-036
- Conditions
- Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chinese men | – | Other: Cardiorespiratory fitness test, Other: Resting measure of fat oxidation, Other: Maximum fat oxidation testChinese 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. |
| Indian men | – | Other: Cardiorespiratory fitness test, Other: Resting measure of fat oxidation, Other: Maximum fat oxidation testIndian 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. |
| Malay men | – | Other: Cardiorespiratory fitness test, Other: Resting measure of fat oxidation, Other: Maximum fat oxidation testMalay 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. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy but physically inactive Chinese, Indian and Malay men aged 21-45 years with an elevated body mass index for Asians.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiorespiratory fitness testAlso: Graded exercise test, submaximal oxygen uptake testProgressive submaximal exercise test on a treadmill to predict cardiorespiratory fitness | Other | Chinese men, Indian men, Malay men |
| Resting measure of fat oxidationAlso: Resting energy expenditure, resting substrate oxidation testUse of ventilated hood attached to automated metabolic cart to measure substrate oxidation at rest | Other | Chinese men, Indian men, Malay men |
| Maximum fat oxidation testProgressive exercise test to determine maximum fat oxidation during exercise | Other | Chinese men, Indian men, Malay men |
Primary outcome
Cardiorespiratory fitness
Time frame: 1 day (Single measurement)
Predicted measure of maximum oxygen uptake during exercise
Resting fat oxidation
Time frame: 1 day (Single measurement)
Measure of amount of fat oxidised whilst at rest in the postabsorptive (fasting) state
Maximum fat oxidation (exercise)
Time frame: 1 day (Single measurement)
Measure of maximum amount of fat oxidised whilst exercising in the postabsorptive state
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Derived from this study: PubMed 35679614Demashkieh M, Dalan R, Burns SF. Cardiorespiratory fitness and fat oxidation during exercise in Chinese, Indian, and Malay men with elevated body mass index. Appl Physiol Nutr Metab. 2022 Aug 1;47(8):888-892. doi: 10.1139/apnm-2022-0106. Epub 2022 Jun 9.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen F Burns, PhD principal investigator
Nanyang Technological University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Nanyang Technological University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: 1 day (Single measurement)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05337111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.