Cycling for weight loss in an 'altitude simulation chamber'
| ISRCTN | ISRCTN11842323 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11842323 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | CMO nr: 2009/341; ABR nr: 29211.091.09 |
| Sponsor | HAN University of Applied Sciences |
| Funders | Investigator initiated and funded, Wageningen University and Research Centre, PIDON Fund (Dutch Ministry of Economic Affairs) |
- Submission date
- 05/03/2021
- Registration date
- 25/05/2021
- Last edited
- 05/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and aims
Women willing to lose overweight may do so by reducing their food intake or by enhancing their physical activity but the results of both approaches rely on the nutrients involved. It is hypothesized that cycling under mildly reduced environmental oxygen consumes more body fat than cycling under normal environmental oxygen conditions. Results will be used to optimize oxidation of body fat for weight loss by low-intensity cycling.
Who can participate?
Healthy women aged 20 - 40 years, willing to lose overweight by low-intensity cycling.
What does the study involve?
Women with overweight perform a 50-min cycling protocol, that encloses phases of rest, cycling at a personalized low intensity and of recovery, in an 'altitude simulation chamber' at two occasions within a period of 2 weeks, in randomized order once under normal (N-Ox: 20.9 %) and once under mildly reduced (R-OX: 17.0 %) normobaric oxygen. O2 consumption and CO2 production of subjects are measured continuously by use of a 'ventilated hood system'. Results inform about the metabolic costs of cycling and the ratio in which these costs are covered by carbohydrates and fat. Moreover, 4 fingertip blood samples are taken to determine glucose and lactate concentrations (mM) to get secondary evidence about the use of carbohydrates and fat during low-intensity cycling in women with overweight.
What are the possible benefits and risk of participating?
Results may help to raise the oxidation of body fat for weight loss by low-intensity cycling.
The risk of mildly reduced oxygen (R-Ox: 17 %), comparable with the oxygen level during a long-distance air flight, is commonly well tolerated by healthy subjects.
Where is the study run from?
HAN University of Applied Sciences, Nijmegen, The Netherlands.
When is the study starting and how long is it expected to run for?
June 2009 to June 2011
Who is funding the study?
HAN University of Applied Sciences, Nijmegen, The Netherlands
WUR University, Wageningen, The Netherlands
Dutch Ministry of Economic Affairs (PIDON fund) - The Netherlands
Who is the main contact?
Dr. Victor V.A.M. Schreurs (vs@glazenkamp.net)
Contact information
Scientific
Research Group Sports, Nutrition and Life style
ISES - HAN University of Applied Sciences
P.O. Box 6960
Nijmegen
NL-6503 GL
Netherlands
 ORCID ID |
0000-0002-9324-7816 |
|---|---|
| Phone | +31.24.3531507 |
| vs@glazenkamp.net |
Public
Research Group Sports, Nutrition and Life style
ISES - HAN University of Applied Sciences
P.O. Box 6960
Nijmegen
NL-6503 GL
Netherlands
| Phone | +31.24.3531507 |
|---|---|
| vs@glazenkamp.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre interventional randomized controlled trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Comparison of metabolic responses to low intensity cycling under normal and mildly reduced normabaric oxygen in women with overweight |
| Study objectives | Cycling under mildly reduced normobaric oxygen in an 'altitude simulation chamber' might be a feasible way to raise oxidation of body fat for weight loss as far as reduced oxygen conditions enhance metabolic costs of exercise e.g. by an urge to increase the recycling of lactate to glucose (Cori cycle). |
| Ethics approval(s) | Approved 23/03/2010, Regional Ethics Committee Arnhem (Radboud UMC, P.O. Box 9101 [internal post 628], NL - 6500 HB Nijmegen - The Netherlands; +31. (0)243613154; commissiemensgebondenonderzoek@radboudumc.nl), ref: CMO nr: 2009/341; ABR nr: 29211.091.09. |
| Health condition(s) or problem(s) studied | To raise oxidation of body fat during low intensity cycling in women willing to lose overweight |
| Intervention | Participants perform a 50-min protocol, enclosing phases of rest, cycling at a personalized low intensity and recovery, in an 'altitude simulation chamber', at two occasions within a period of 2 weeks, in randomized order once under normal (N-Ox: 20.9%) and once under mildly reduced (R-Ox: 17.0%) normobaric oxygen. Within the chamber (2.4 x 3.8 x 2.7m; 25m³) an upright bike ergometer combines with a "ventilated hood system" for open-circuit respiratory gas exchange of cyclists. The 20 participants were listed in alphabetical order of initials and randomised by their odd (N-Ox ~ R-Ox) or even (R-Ox ~ N-Ox) position. |
| Intervention type | Other |
| Primary outcome measure(s) |
Measured during periods of rest, cycling and recovery: |
| Key secondary outcome measure(s) |
1. Blood oxygen saturation (SaO2: %) measured using pulse oximeter |
| Completion date | 01/06/2011 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Women willing to lose overweight by low intensity exercise 2. Low active 3. 20 - 40 years of age |
| Key exclusion criteria | 1. Anemia 2. Type 1 or type 2 diabetes 3. Hypertension 4. Heart disease |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Nijmegen
NL - 6525 EN
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Raw data prepared for publication are stored at Wageningen University and will be made available after publication for a period of 2 years upon reasonable requests for inspection or research purposes. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/04/2022 | 05/05/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/05/2022: Publication reference added.
05/07/2021: The sponsor contact has been updated.
13/04/2021: Trial's existence confirmed by Wageningen.
