Metabolic SyndromeNCT05100797
Validity of the Vyntus CPX Metabolic Cart for Assessing Postprandial Energy Expenditure and Respiratory Exchange Ratio
An observational study of Metabolic Syndrome, run by Universidad de Granada at 1 site in Spain.
Trial summary
The aims of the present study are described below: Aim 1: In-vitro measures to determine the validity, precision and accuracy of the Vyntus CPX metabolic cart assessed by: 1.1. Methanol burning tests. 1.2. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Vyntus CPX
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2021to 23 Mar 2022
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: To be included in the study, the participants have to be healthy and meet the abovementioned inclusion criteria.
Who may be able to join
- Healthy.
- Age 18-40 y.
- BMI between 18.5 kg/m2 and 30 kg/m2 (both inclusive).
- Willing to fast and not to consume non-caloric stimulant for 12h before the assessments.
- Willing to avoid moderate or vigorous physical activity during 24-48h respectively.
- Have a stable body weight over the last 3 months (changes ≤3 kg) and not being enrolled in a weight loss program.
Who cannot join
- Smoking or use of tobacco products within the last 3 months.
- Diagnosed with diabetes.
- Previous bariatric surgery (or other surgeries) for obesity or weight loss.
- Use of medications affecting metabolism or sleep.
- History of neurological disease.
- History of cardiovascular disease, including hypertension, or other chronic diseases.
Show all 9Show fewer
- Pregnant, planning to become pregnant, or breastfeeding.
- Adherence to special restrained diets (e.g., low-carbohydrates, low-fat, or vegetarian/vegan diets) over the last 3 months.
- Claustrophobia impeding to stay calm under a plastic canopy.
Trial locations and contacts
1 site in 1 country.
Juan Manuel Alcántara Alcántara, Dr. contact
Spain1 site, 1 recruiting
- Recruiting
University of Granada
Granada, 18011
Jonatan Ruiz Ruiz, Dr., 958242754 ext. 34, ruizj@ugr.es
Juan Manuel Alcántara Alcántara, Dr., alcantarajma@ugr.es
About this study
The aims of the present study are described below:
Aim 1: In-vitro measures to determine the validity, precision and accuracy of the Vyntus CPX metabolic cart assessed by:
Read more
1.1. Methanol burning tests. 1.2. Pure gas (nitrogen [N2] and carbon dioxide [CO2]) infusions to simulate both, constant and variable fluxes of oxygen consumption (VO2) and carbon dioxide production (VCO2) in different conditions and moments.
- Immediately after or prior the methanol burning test (in a randomized order).
- In separate days and time-periods.
Aim 2: In-vivo measures using the Vyntus CPX metabolic cart:
2.1. To assess the resting metabolic rate (RMR or resting energy expenditure [REE]) and respiratory exchange ratio (RER) day-to-day biological reproducibility (i.e. reliability) of the metabolic cart.
2.2. Further, the investigators will use an oral glucose tolerance test (OGTT) to determine the post-prandial day-to-day biological reproducibility (especifically the post-prandial RER) of the metabolic cart.
Read the detailed description
The study will be developed in three different experiments which are detailed below:
EXPERIMENT 1 (AIM 1.1 AND 1.2.A):
The investigators will determine the Vyntus CPX measurement error over 14 different days by using both, methanol burnings and pure gas infusions. The order will be random.
- Methanol burning: the investigators will burn the methanol inside the glass-cage and the investigators will measure dynamically the weight of burned alcohol; gas exchange will be continuously measured with the Vyntus CPX while the produced gases are directed into the metabolic cart's hose tube. The burning will take approximately 25-30 minutes and is expected to produce a RER=0.667.
- Pure gas infusions: Pure N2 (concentration ≥99.9997%) for diluting ambient O2 and CO2 (concentration ≥99.995%) will be infused using high-precision mass-flow controllers (358 Series, Analyt-MTC, Müllheim, Germany; 0-2 l/min) into the metabolic cart's hose tube. The infused volumes of N2 and CO2 will be selected to replicate (i.e. mimic) as much as possible the VO2 and VCO2 produced by the methanol burning test. The gas infusions will last 20 minutes.
EXPERIMENT 2 (AIM 1.2.B):
The investigators will determine the Vyntus CPX measurement error over 14 different days by using pure gas infusions (each pure gas infusion will last 20 minutes). The procedures will be as follow:
- Pure gas infusions varying, in a random order, the simulated VO2 and VCO2 to poduce different energy expenditure (EE) and RER values: the investigators will infuse pure N2 and CO2 gases at different volumes. The infusions will be performed either in the morning or in the afternoon (i.e. random) in 14 different and separate days. The randomly selected simulated EE will range between 1000 and 2000 kilocalories per day (kcal/day) while the RER will range between 0.80 and 0.95. The investigators will perform 5 pure gas infusions per day.
- Pure gas infusions varying, in a random order, the simulated VO2 and VCO2 to produce different EE values while keeping a constant RER: the investigators will infuse pure N2 and CO2 gases at different volumes. The infusions will be performed either in the morning or in the afternoon (i.e. random) in 14 different and separate days. The randomly selected simulated EE will range between 1000 and 2000 kcal/day while the RER is fixed at 0.85. The investigators will perform 5 pure gas infusions per day.
- Pure gas infusions varying, in a random order, the simulated VO2 and VCO2 to produce different RER values while keeping a constant EE: the investigators will infuse pure N2 and CO2 gases at different volumes. The infusions will be performed either in the morning or in the afternoon (i.e. random) in 14 different and separate days. The randomly selected simulated RER will range between 0.80 and 0.95 while the EE is fixed at 1500 kcal/day. The investigators will perform 5 pure gas infusions per day.
EXPERIMENT 3 (AIM 2.1 and 2.2.):
The investigators will assess the RMR and RER of 10-15 young-healthy adults using the Vyntus CPX metabolic cart on two consecutive days in the morning. The assessment will last 30 minutes and will be performed in agreement with current guidelines. The subjects will lay on a reclined bed in supine position and covered by a bed sheet for 20 minutes before the assessment as an 'acclimation period'. Immediately after this acclimation period the RMR and RER assessment will start under the same conditions. Then, the glucose beverage (75g of glucose/200ml) is given to the participants and another 180 minutes of assessment are performed.
In addition, the participants' weight, height and body composition (using a dual X-ray absorptiometry scan [DXA scan]) will be measured upon arrival on the first visit. Blood samples will be collected at different time periods to determine the blood glucose concentration. Lastly, participants will be asked to consume a standardized dinner (specifically designed by a dietitians team) the night before each study day.
- Conditions
- Metabolic Syndrome
- Being tested
- Vyntus CPX
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vyntus CPXDevice
To study the validity, precision and accuracy of the Vyntus CPX metabolic cart using both, in-vitro and in-vivo (i.e., human study) measures.
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 post-prandial gas exchange assessed by indirect calorimetry
Volume of oxygen consumption (VO2 [ml/min])
Measured: 5 hours
VCO2 post-prandial gas exchange assessed by indirect calorimetry
Volume of carbon dioxide production (VCO2 [ml/min])
Measured: 5 hours
EE post-prandial gas exchange assessed by indirect calorimetry
-Energy Expenditure (EE [kcal/day])
Measured: 5 hours
RER post-prandial gas exchange assessed by indirect calorimetry
Respiratory Exchange Ratio (RER [calculated as VCO2-to-VO2 ratio])
Measured: 5 hours
CHOox post-prandial gas exchange assessed by indirect calorimetry
Carbohydrate oxidation (CHOox [g/min])
Measured: 5 hours
FATox post-prandial gas exchange assessed by indirect calorimetry
Fat oxidation (FATox [g/min])
Measured: 5 hours
VO2 validity of the metabolic cart. In-vitro measurements and/or simulations to determine the validity, precision and accuracy of the metabolic cart assessed by methanol burning tests and controlled pure gas infusions.
Volume of oxygen consumption (VO2) measurement error (ml/min)
Measured: 14 separate days; measurements of 2 hours per day
VCO2 validity of the metabolic cart. In-vitro measurements and/or simulations to determine the validity, precision and accuracy of the metabolic cart assessed by methanol burning tests and controlled pure gas infusions.
Volume of carbon dioxide production (VCO2) measurement error (ml/min)
Measured: 14 separate days; measurements of 2 hours per day
EE validity of the metabolic cart. In-vitro measurements and/or simulations to determine the validity, precision and accuracy of the metabolic cart assessed by methanol burning tests and controlled pure gas infusions.
Energy Expenditure (EE) measurement error (kcal/day)
Measured: 14 separate days; measurements of 2 hours per day
RER validity of the metabolic cart. In-vitro measurements and/or simulations to determine the validity, precision and accuracy of the metabolic cart assessed by methanol burning tests and controlled pure gas infusions.
Respiratory Exchange Ratio (RER) measurement error
Measured: 14 separate days; measurements of 2 hours per day
Secondary outcomes (5)
Post-prandial blood glucose concentrations
Measures of blood glucose concentrations (mg/dl)
Measured: 5 hours
Body composition outcomes (DXA scann)
Lean mass, fat-free mass and fat mass in kilograms
Measured: 1 day
Anthropometric measurements 1, weight
Weight in kilograms
Measured: 1 day
Anthropometric measurements 2, height
Height in meters
Measured: 1 day
Anthropometric measurements 3, body mass index
BMI: Weight and height will be combined to report in kg/m^2
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start20 Dec 2021
- Primary completion23 Feb 2022 (estimated)
- Study completion23 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonatan Ruiz Ruiz, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100797
- Sponsor's protocol ID
- 2190/CEIH/2021
- Status last verified
- Dec 2021
- First submitted
- 16 Sep 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the Vyntus CPX Metabolic Cart for Assessing Postprandial Energy Expenditure and Respiratory Exchange Ratio
- ClinicalTrials.gov ID
- NCT05100797
- Acronym / sponsor ID
- 2190/CEIH/2021
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 23 Feb 2022 (estimated)
- Study completion
- 23 Mar 2022 (estimated)
- First posted
- 29 Oct 2021 (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.
The aims of the present study are described below:
Aim 1: In-vitro measures to determine the validity, precision and accuracy of the Vyntus CPX metabolic cart assessed by:
1.1. Methanol burning tests. 1.2. Pure gas (nitrogen [N2] and carbon dioxide [CO2]) infusions to simulate both, constant and variable fluxes of oxygen consumption (VO2) and carbon dioxide production (VCO2) in different conditions and moments.
- Immediately after or prior the methanol burning test (in a randomized order).
- In separate days and time-periods.
Aim 2: In-vivo measures using the Vyntus CPX metabolic cart:
2.1. To assess the resting metabolic rate (RMR or resting energy expenditure [REE]) and respiratory exchange ratio (RER) day-to-day biological reproducibility (i.e. reliability) of the metabolic cart.
2.2. Further, the investigators will use an oral glucose tolerance test (OGTT) to determine the post-prandial day-to-day biological reproducibility (especifically the post-prandial RER) of the metabolic cart.
Detailed description
The study will be developed in three different experiments which are detailed below:
EXPERIMENT 1 (AIM 1.1 AND 1.2.A):
The investigators will determine the Vyntus CPX measurement error over 14 different days by using both, methanol burnings and pure gas infusions. The order will be random.
- Methanol burning: the investigators will burn the methanol inside the glass-cage and the investigators will measure dynamically the weight of burned alcohol; gas exchange will be continuously measured with the Vyntus CPX while the produced gases are directed into the metabolic cart's hose tube. The burning will take approximately 25-30 minutes and is expected to produce a RER=0.667.
- Pure gas infusions: Pure N2 (concentration ≥99.9997%) for diluting ambient O2 and CO2 (concentration ≥99.995%) will be infused using high-precision mass-flow controllers (358 Series, Analyt-MTC, Müllheim, Germany; 0-2 l/min) into the metabolic cart's hose tube. The infused volumes of N2 and CO2 will be selected to replicate (i.e. mimic) as much as possible the VO2 and VCO2 produced by the methanol burning test. The gas infusions will last 20 minutes.
EXPERIMENT 2 (AIM 1.2.B):
The investigators will determine the Vyntus CPX measurement error over 14 different days by using pure gas infusions (each pure gas infusion will last 20 minutes). The procedures will be as follow:
- Pure gas infusions varying, in a random order, the simulated VO2 and VCO2 to poduce different energy expenditure (EE) and RER values: the investigators will infuse pure N2 and CO2 gases at different volumes. The infusions will be performed either in the morning or in the afternoon (i.e. random) in 14 different and separate days. The randomly selected simulated EE will range between 1000 and 2000 kilocalories per day (kcal/day) while the RER will range between 0.80 and 0.95. The investigators will perform 5 pure gas infusions per day.
- Pure gas infusions varying, in a random order, the simulated VO2 and VCO2 to produce different EE values while keeping a constant RER: the investigators will infuse pure N2 and CO2 gases at different volumes. The infusions will be performed either in the morning or in the afternoon (i.e. random) in 14 different and separate days. The randomly selected simulated EE will range between 1000 and 2000 kcal/day while the RER is fixed at 0.85. The investigators will perform 5 pure gas infusions per day.
- Pure gas infusions varying, in a random order, the simulated VO2 and VCO2 to produce different RER values while keeping a constant EE: the investigators will infuse pure N2 and CO2 gases at different volumes. The infusions will be performed either in the morning or in the afternoon (i.e. random) in 14 different and separate days. The randomly selected simulated RER will range between 0.80 and 0.95 while the EE is fixed at 1500 kcal/day. The investigators will perform 5 pure gas infusions per day.
EXPERIMENT 3 (AIM 2.1 and 2.2.):
The investigators will assess the RMR and RER of 10-15 young-healthy adults using the Vyntus CPX metabolic cart on two consecutive days in the morning. The assessment will last 30 minutes and will be performed in agreement with current guidelines. The subjects will lay on a reclined bed in supine position and covered by a bed sheet for 20 minutes before the assessment as an 'acclimation period'. Immediately after this acclimation period the RMR and RER assessment will start under the same conditions. Then, the glucose beverage (75g of glucose/200ml) is given to the participants and another 180 minutes of assessment are performed.
In addition, the participants' weight, height and body composition (using a dual X-ray absorptiometry scan [DXA scan]) will be measured upon arrival on the first visit. Blood samples will be collected at different time periods to determine the blood glucose concentration. Lastly, participants will be asked to consume a standardized dinner (specifically designed by a dietitians team) the night before each study day.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- To be included in the study, the participants have to be healthy and meet the abovementioned inclusion criteria.
Key inclusion criteria (6 listed)
- Healthy.
- Age 18-40 y.
- BMI between 18.5 kg/m2 and 30 kg/m2 (both inclusive).
- Willing to fast and not to consume non-caloric stimulant for 12h before the assessments.
- Willing to avoid moderate or vigorous physical activity during 24-48h respectively.
Key exclusion criteria (9 listed)
- Smoking or use of tobacco products within the last 3 months.
- Diagnosed with diabetes.
- Previous bariatric surgery (or other surgeries) for obesity or weight loss.
- Use of medications affecting metabolism or sleep.
- History of neurological disease.
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 |
|---|---|---|
| Vyntus CPXTo study the validity, precision and accuracy of the Vyntus CPX metabolic cart using both, in-vitro and in-vivo (i.e., human study) measures. | Device | – |
Primary outcome
VO2 post-prandial gas exchange assessed by indirect calorimetry
Time frame: 5 hours
Volume of oxygen consumption (VO2 [ml/min])
VCO2 post-prandial gas exchange assessed by indirect calorimetry
Time frame: 5 hours
Volume of carbon dioxide production (VCO2 [ml/min])
EE post-prandial gas exchange assessed by indirect calorimetry
Time frame: 5 hours
-Energy Expenditure (EE [kcal/day])
RER post-prandial gas exchange assessed by indirect calorimetry
Time frame: 5 hours
Respiratory Exchange Ratio (RER [calculated as VCO2-to-VO2 ratio])
CHOox post-prandial gas exchange assessed by indirect calorimetry
Time frame: 5 hours
Carbohydrate oxidation (CHOox [g/min])
FATox post-prandial gas exchange assessed by indirect calorimetry
Time frame: 5 hours
Fat oxidation (FATox [g/min])
VO2 validity of the metabolic cart. In-vitro measurements and/or simulations to determine the validity, precision and accuracy of the metabolic cart assessed by methanol burning tests and controlled pure gas infusions.
Time frame: 14 separate days; measurements of 2 hours per day
Volume of oxygen consumption (VO2) measurement error (ml/min)
VCO2 validity of the metabolic cart. In-vitro measurements and/or simulations to determine the validity, precision and accuracy of the metabolic cart assessed by methanol burning tests and controlled pure gas infusions.
Time frame: 14 separate days; measurements of 2 hours per day
Volume of carbon dioxide production (VCO2) measurement error (ml/min)
EE validity of the metabolic cart. In-vitro measurements and/or simulations to determine the validity, precision and accuracy of the metabolic cart assessed by methanol burning tests and controlled pure gas infusions.
Time frame: 14 separate days; measurements of 2 hours per day
Energy Expenditure (EE) measurement error (kcal/day)
RER validity of the metabolic cart. In-vitro measurements and/or simulations to determine the validity, precision and accuracy of the metabolic cart assessed by methanol burning tests and controlled pure gas infusions.
Time frame: 14 separate days; measurements of 2 hours per day
Respiratory Exchange Ratio (RER) measurement error
5 secondary outcomes
Post-prandial blood glucose concentrations
Time frame: 5 hours
Body composition outcomes (DXA scann)
Time frame: 1 day
Anthropometric measurements 1, weight
Time frame: 1 day
Anthropometric measurements 2, height
Time frame: 1 day
Anthropometric measurements 3, body mass index
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Juan Manuel Alcántara Alcántara, Dr. contact
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 Metabolic Syndrome, run by Universidad de Granada at 1 site in Spain.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Dec 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonatan Ruiz Ruiz, Dr. (958242754 ext. 34, ruizj@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 post-prandial gas exchange assessed by indirect calorimetry (time frame: 5 hours). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2021.