NCT05337111

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

April 14, 2022

Last Update Submit

April 19, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Cardiorespiratory fitness

    Predicted measure of maximum oxygen uptake during exercise

    1 day (Single measurement)

  • Resting fat oxidation

    Measure of amount of fat oxidised whilst at rest in the postabsorptive (fasting) state

    1 day (Single measurement)

  • Maximum fat oxidation (exercise)

    Measure of maximum amount of fat oxidised whilst exercising in the postabsorptive state

    1 day (Single measurement)

Study Arms (3)

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 testOther: Resting measure of fat oxidationOther: 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.

Other: Cardiorespiratory fitness testOther: Resting measure of fat oxidationOther: 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.

Other: Cardiorespiratory fitness testOther: Resting measure of fat oxidationOther: Maximum fat oxidation test

Interventions

Progressive submaximal exercise test on a treadmill to predict cardiorespiratory fitness

Also known as: Graded exercise test, submaximal oxygen uptake test
Chinese menIndian menMalay men

Use of ventilated hood attached to automated metabolic cart to measure substrate oxidation at rest

Also known as: Resting energy expenditure, resting substrate oxidation test
Chinese menIndian menMalay men

Progressive exercise test to determine maximum fat oxidation during exercise

Chinese menIndian menMalay men

Eligibility Criteria

Age21 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University

Singapore, 637616, Singapore

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen F Burns, PhD

    Nanyang Technological University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 20, 2022

Study Start

July 1, 2019

Primary Completion

March 30, 2020

Study Completion

July 31, 2020

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

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.

Locations