Respiratory Function LossHIC1NCT06248437
Prototype of Innovative Food Product to Improve Respiratory and Peripheral Muscle Function in Humans
An observational study of Respiratory Function Loss and Sarcopenia, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
Trial summary
HIC1® compound has a presence in the form of a gel, which facilitates its oral intake (direct or diluted with water) and also administration through gastrostomy tubes or nasogastric tubes. All received a dose of 30 grams of gel. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Function Loss, Sarcopenia
- What is being tested?
- innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilage
- How many people
- 30 participants
- Where
- 1 siteColombia
- Study dates
- 30 Mar 2019to 30 Mar 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Measures before and after the application of the treatment was developed in a highly complex institution in Bucaramanga, Santander. The sample size were a convenience sampling was done, with a total of 29 participants assigned to one of three groups: healthy participants (n = 10), patients with COPD (n = 10), and patients receiving mechanical ventilation in the Intensive Care Unit (ICU) (n = 14) due to severe respiratory disease. Five ICU patients were discontinued from the study due to clinical changes unrelated to the nutraceutical-
Who may be able to join
- patients with COPD
- patients receiving mechanical ventilation in the Intensive Care Unit (ICU)
- Age ≥ 18 years
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Cardiovascular de Colombia
Floridablanca, Santander Department, 681004
About this study
Official title: Undertaking for the Sensory, Functional and Stability Validation of an Innovative Food Product Prototype to Improve Respiratory and Peripheral Muscle Function in Humans
HIC1® compound has a presence in the form of a gel, which facilitates its oral intake (direct or diluted with water) and also administration through gastrostomy tubes or nasogastric tubes. All received a dose of 30 grams of gel.
Read the detailed description
Sample Size: A convenience sampling was done, with a total of 29 participants assigned to one of three groups: healthy participants (n = 10), patients with COPD (n = 10), and patients receiving mechanical ventilation in the Intensive Care Unit (ICU) (n = 14) due to severe respiratory disease.
Data collection and variables. All participants completed a survey on sociodemographic data (age, sex, respiratory problems, smoking, among others). Weight, height, skin folds, and a blood sample were taken to quantify the Oxygen Radical Absorption Capacity (ORAC) units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and lipid profile. At that time, they were explained how they should eat the nutraceutical food, starting the next day and for five consecutive days.
During those 5 days, a nurse made contact calls to verify that the participant took the corresponding dose for the day. After 5 days of ingesting the nutraceutical compound, a blood sample was taken again to quantify post-ingestion levels of ORAC units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and the lipid profile. In the case of the participants in the ICU, control visits were made to the unit to verify that the dose was delivered to the participant.
Form and Ingredients of the nutraceutical compound. HIC1® compound has a presence in the form of a gel, which facilitates its oral intake (direct or diluted with water) and also administration through gastrostomy tubes or nasogastric tubes.
List of ingredients: Coffee mucilage concentrate (49.26%), water (21.76%), L-glutamine (11%), beta-alanine (7.07%), magnesium chloride (2.9%), citric acid (1.48%), natural blackberry flavor (1.3%), milk protein extract (1.23%), soy protein (1.22%), tricalcium phosphate (1.06%), nutrient supplement (1%), sodium citrate (0.3%), ascorbic acid (0.15%), Stevia (0.11%), sucralose (0.11%), leucine (0.05%) and vitamin D (0.000027%).
Serum marker quantifications. Peripheral blood samples (~ 20 cc each) were obtained by venipuncture in the forearm of each participant, before starting the ingestion of the nutraceutical food (pre) and five days after its ingestion (post). The sample was transported from the sampling site to the clinical laboratory to detect the following elements:
- Radical Absorption Capacity of Oxygen (ORAC). The method used by the laboratory was AOAC 2012.23 Official Methods of Analysis, 21st Edition (2019). Results are given in units (mM eq Trolox)
- Amino acids. Twenty-three amino acids were quantified in Serum/Plasma with the Gas Chromatography technique with flame ionization detector.
- Vitamins and minerals:
- Vitamin B12. The method used by the laboratory was the Microparticle Chemiluminescent Immunoassay.
- Vitamin D. The method used by the laboratory was
- Folic acid. The method used by the laboratory was chemiluminescence.
- Calcium. The method used by the laboratory was colorimetric, Arsenazo III.
- Magnesium. The method used by the laboratory was enzymatic.
- Phosphorus. The method used by the laboratory was phosphomolybdate.
- Lipid profile and Apolipoproteins:
- Total cholesterol. The method used by the laboratory was the Cholesterol Oxidase Phenol 4-Aminoantipyrine Peroxidase enzyme
- High-density lipoprotein (HDL). The method used by the laboratory was Accelerator Selective Detergent.
- Low-density lipoprotein (LDL). The method used by the laboratory was Accelerator Selective Detergent.
- Triglycerides. The method used by the laboratory was Glycerol phosphate oxidase.
- Apolipoproteins A1. The method used by the laboratory was Immunoturbidimetry.
- Apolipoprotein B. The method used by the laboratory was Immunoturbidimetry
Statistical analyses. Variables are reported as mean (±standard deviation) and absolute and relative frequencies. Serum values are presented with medians and interquartile ranges. The p values were quantified using Mann-Whitney-Wilcoxon. Statistical analysis was done in Stata 15.
Ethical approval. The study protocol was approved for the institutional ethics review board Fundación Cardiovascular de Colombia, according to Act No. 119 of 2017. Written informed consent was obtained directly from all participants.
- Conditions
- Respiratory Function Loss, Sarcopenia
- Being tested
- innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilage
- Keywords
- Antioxidant, Nutraceutical, Respiratory muscle, Peripheral muscle, Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilageOther
Also called Innovative nutraceutical-type food product that we designed called HIC1®
All participants completed a survey on sociodemographic data (age, sex, respiratory problems, smoking, among others). Weight, height, skin folds, and a blood sample were taken to quantify the Oxygen Radical Absorption Capacity (ORAC) units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and lipid profile. At that time, they were explained how they should eat the nutraceutical food, starting the next day and for five consecutive days. During those 5 days, a nurse made contact calls to verify that the participant took the corresponding dose for the day. After 5 days of ingesting the nutraceutical compound, a blood sample was taken again to quantify post-ingestion levels of ORAC units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and the lipid profile. In the case of the participants in the ICU, control visits were made to the unit to verify that the dose was delivered to the participant
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Healthy participants (n = 10). At that time, they were explained how they should eat the nutraceutical food (HIC1®), starting the next day and for five consecutive days. During those 5 days, a nurse made contact calls to verify that the participant took the corresponding dose for the day. After 5 days of ingesting the nutraceutical compound, a blood sample was taken again to quantify post-ingestion levels of ORAC units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and the lipid profile. Receives: Other: innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilage | |
| Patients with COPD | Patients with COPD (n = 10). At that time, they were explained how they should eat the nutraceutical food (HIC1®), starting the next day and for five consecutive days. During those 5 days, a nurse made contact calls to verify that the participant took the corresponding dose for the day. After 5 days of ingesting the nutraceutical compound, a blood sample was taken again to quantify post-ingestion levels of ORAC units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and the lipid profile. Receives: Other: innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilage | |
| Patients in the Intensive Care Unit (ICU) | Patients receiving mechanical ventilation in the Intensive Care Unit (ICU) (n=10)
At that time, they were explained how they should eat the nutraceutical food (HIC1®), starting the next day and for five consecutive days. During those 5 days, a nurse made contact calls to verify that the participant took the corresponding dose for the day. After 5 days of ingesting the nutraceutical compound, a blood sample was taken again to quantify post-ingestion levels of ORAC units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and the lipid profile. In the case of the participants in the ICU, control visits were made to the unit to verify that the dose was delivered to the participant Receives: Other: innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygen Radical Absorbance Capacity and day 5
Measurement of ORAC units, (Trolox mM eq) using The method used by the laboratory was AOAC 2012.23 Official Methods of Analysis, 21st Edition (2019)
Measured: Baseline and day 5
Secondary outcomes (3)
Change in amino acids and day 5
Amino acids. Twenty-three amino acids were quantified in Serum/Plasma with the Gas Chromatography technique with flame ionization detector
Measured: Baseline and day 5
Change in Vitamins and minerals
Vitamin B12. The method used by the laboratory was the Microparticle Chemiluminescent Immunoassay.
Vitamin D. The method used by the laboratory was Folic acid. The method used by the laboratory was chemiluminescence. Calcium. The method used by the laboratory was colorimetric, Arsenazo III. Magnesium. The method used by the laboratory was enzymatic. Phosphorus. The method used by the laboratory was phosphomolybdate
Measured: Baseline and day 5
Change in Lipid profile and Apolipoproteins
Total cholesterol. The method used by the laboratory was the Cholesterol Oxidase Phenol 4-Aminoantipyrine Peroxidase enzyme High-density lipoprotein (HDL). The method used by the laboratory was Accelerator Selective Detergent.
Low-density lipoprotein (LDL). The method used by the laboratory was Accelerator Selective Detergent.
Triglycerides. The method used by the laboratory was Glycerol phosphate oxidase.
Apolipoproteins A1. The method used by the laboratory was Immunoturbidimetry. Apolipoprotein B. The method used by the laboratory was Immunoturbidimetry
Measured: Baseline and day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start30 Mar 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory Function LossStudies 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Cardiovascular de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Sanadores Ambientales SANAM Company SAS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248437
- Sponsor's protocol ID
- HIC1-Nutra-2017
- Acronym
- HIC1
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Orozco-Levi M, Coronell C, Ramirez-Sarmiento A, Lloreta J, Martinez-Llorens J, Galdiz JB, Gea J. Injury of peripheral muscles in smokers with chronic obstructive pulmonary disease. Ultrastruct Pathol. 2012 Aug;36(4):228-38. doi: 10.3109/01913123.2012.668611.
PubMed 22849524Gea J, Pascual S, Casadevall C, Orozco-Levi M, Barreiro E. Muscle dysfunction in chronic obstructive pulmonary disease: update on causes and biological findings. J Thorac Dis. 2015 Oct;7(10):E418-38. doi: 10.3978/j.issn.2072-1439.2015.08.04.
PubMed 26623119Martinez-Llorens JM, Orozco-Levi M, Masdeu MJ, Coronell C, Ramirez-Sarmiento A, Sanjuas C, Broquetas JM, Gea J. [Global muscle dysfunction and exacerbation of COPD: a cohort study]. Med Clin (Barc). 2004 Apr 17;122(14):521-7. doi: 10.1016/s0025-7753(04)74294-3. Spanish.
PubMed 15117643Barreiro E, Ferrer D, Sanchez F, Minguella J, Marin-Corral J, Martinez-Llorens J, Lloreta J, Gea J. Inflammatory cells and apoptosis in respiratory and limb muscles of patients with COPD. J Appl Physiol (1985). 2011 Sep;111(3):808-17. doi: 10.1152/japplphysiol.01017.2010. Epub 2011 Jun 2.
PubMed 21636562
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undertaking for the Sensory, Functional and Stability Validation of an Innovative Food Product Prototype to Improve Respiratory and Peripheral Muscle Function in Humans
- ClinicalTrials.gov ID
- NCT06248437
- Acronym / sponsor ID
- HIC1 / HIC1-Nutra-2017
- Conditions
- Respiratory Function Loss, Sarcopenia
- Keywords
- Antioxidant, Nutraceutical, Respiratory muscle, Peripheral muscle, Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundación Cardiovascular de ColombiaUniversity, hospital or other
- Collaborators
- Sanadores Ambientales SANAM Company SAS
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 8 Feb 2024 (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.
HIC1® compound has a presence in the form of a gel, which facilitates its oral intake (direct or diluted with water) and also administration through gastrostomy tubes or nasogastric tubes. All received a dose of 30 grams of gel.
Detailed description
Sample Size: A convenience sampling was done, with a total of 29 participants assigned to one of three groups: healthy participants (n = 10), patients with COPD (n = 10), and patients receiving mechanical ventilation in the Intensive Care Unit (ICU) (n = 14) due to severe respiratory disease.
Data collection and variables. All participants completed a survey on sociodemographic data (age, sex, respiratory problems, smoking, among others). Weight, height, skin folds, and a blood sample were taken to quantify the Oxygen Radical Absorption Capacity (ORAC) units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and lipid profile. At that time, they were explained how they should eat the nutraceutical food, starting the next day and for five consecutive days.
During those 5 days, a nurse made contact calls to verify that the participant took the corresponding dose for the day. After 5 days of ingesting the nutraceutical compound, a blood sample was taken again to quantify post-ingestion levels of ORAC units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and the lipid profile. In the case of the participants in the ICU, control visits were made to the unit to verify that the dose was delivered to the participant.
Form and Ingredients of the nutraceutical compound. HIC1® compound has a presence in the form of a gel, which facilitates its oral intake (direct or diluted with water) and also administration through gastrostomy tubes or nasogastric tubes.
List of ingredients: Coffee mucilage concentrate (49.26%), water (21.76%), L-glutamine (11%), beta-alanine (7.07%), magnesium chloride (2.9%), citric acid (1.48%), natural blackberry flavor (1.3%), milk protein extract (1.23%), soy protein (1.22%), tricalcium phosphate (1.06%), nutrient supplement (1%), sodium citrate (0.3%), ascorbic acid (0.15%), Stevia (0.11%), sucralose (0.11%), leucine (0.05%) and vitamin D (0.000027%).
Serum marker quantifications. Peripheral blood samples (~ 20 cc each) were obtained by venipuncture in the forearm of each participant, before starting the ingestion of the nutraceutical food (pre) and five days after its ingestion (post). The sample was transported from the sampling site to the clinical laboratory to detect the following elements:
- Radical Absorption Capacity of Oxygen (ORAC). The method used by the laboratory was AOAC 2012.23 Official Methods of Analysis, 21st Edition (2019). Results are given in units (mM eq Trolox)
- Amino acids. Twenty-three amino acids were quantified in Serum/Plasma with the Gas Chromatography technique with flame ionization detector.
- Vitamins and minerals:
- Vitamin B12. The method used by the laboratory was the Microparticle Chemiluminescent Immunoassay.
- Vitamin D. The method used by the laboratory was
- Folic acid. The method used by the laboratory was chemiluminescence.
- Calcium. The method used by the laboratory was colorimetric, Arsenazo III.
- Magnesium. The method used by the laboratory was enzymatic.
- Phosphorus. The method used by the laboratory was phosphomolybdate.
- Lipid profile and Apolipoproteins:
- Total cholesterol. The method used by the laboratory was the Cholesterol Oxidase Phenol 4-Aminoantipyrine Peroxidase enzyme
- High-density lipoprotein (HDL). The method used by the laboratory was Accelerator Selective Detergent.
- Low-density lipoprotein (LDL). The method used by the laboratory was Accelerator Selective Detergent.
- Triglycerides. The method used by the laboratory was Glycerol phosphate oxidase.
- Apolipoproteins A1. The method used by the laboratory was Immunoturbidimetry.
- Apolipoprotein B. The method used by the laboratory was Immunoturbidimetry
Statistical analyses. Variables are reported as mean (±standard deviation) and absolute and relative frequencies. Serum values are presented with medians and interquartile ranges. The p values were quantified using Mann-Whitney-Wilcoxon. Statistical analysis was done in Stata 15.
Ethical approval. The study protocol was approved for the institutional ethics review board Fundación Cardiovascular de Colombia, according to Act No. 119 of 2017. Written informed consent was obtained directly from all participants.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Other: innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilageHealthy participants (n = 10). At that time, they were explained how they should eat the nutraceutical food (HIC1®), starting the next day and for five consecutive days. During those 5 days, a nurse made contact calls to verify that the participant took the corresponding dose for the day. After 5 days of ingesting the nutraceutical compound, a blood sample was taken again to quantify post-ingestion levels of ORAC units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and the lipid profile. |
| Patients with COPD | – | Other: innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilagePatients with COPD (n = 10). At that time, they were explained how they should eat the nutraceutical food (HIC1®), starting the next day and for five consecutive days. During those 5 days, a nurse made contact calls to verify that the participant took the corresponding dose for the day. After 5 days of ingesting the nutraceutical compound, a blood sample was taken again to quantify post-ingestion levels of ORAC units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and the lipid profile. |
| Patients in the Intensive Care Unit (ICU) | – | Other: innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilagePatients receiving mechanical ventilation in the Intensive Care Unit (ICU) (n=10) At that time, they were explained how they should eat the nutraceutical food (HIC1®), starting the next day and for five consecutive days. During those 5 days, a nurse made contact calls to verify that the participant took the corresponding dose for the day. After 5 days of ingesting the nutraceutical compound, a blood sample was taken again to quantify post-ingestion levels of ORAC units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and the lipid profile. In the case of the participants in the ICU, control visits were made to the unit to verify that the dose was delivered to the participant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Measures before and after the application of the treatment was developed in a highly complex institution in Bucaramanga, Santander. The sample size were a convenience sampling was done, with a total of 29 participants assigned to one of three groups: healthy participants (n = 10), patients with COPD (n = 10), and patients receiving mechanical ventilation in the Intensive Care Unit (ICU) (n = 14) due to severe respiratory disease. Five ICU patients were discontinued from the study due to clinical changes unrelated to the nutraceutical-
Key inclusion criteria (3 listed)
- patients with COPD
- patients receiving mechanical ventilation in the Intensive Care Unit (ICU)
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilageAlso: Innovative nutraceutical-type food product that we designed called HIC1®All participants completed a survey on sociodemographic data (age, sex, respiratory problems, smoking, among others). Weight, height, skin folds, and a blood sample were taken to quantify the Oxygen Radical Absorption Capacity (ORAC) units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and lipid profile. At that time, they were explained how they should eat the nutraceutical food, starting the next day and for five consecutive days. During those 5 days, a nurse made contact calls to verify that the participant took the corresponding dose for the day. After 5 days of ingesting the nutraceutical compound, a blood sample was taken again to quantify post-ingestion levels of ORAC units, amino acids, vitamin B12, vitamin D, phosphorus, magnesium, calcium, and the lipid profile. In the case of the participants in the ICU, control visits were made to the unit to verify that the dose was delivered to the participant | Other | Healthy participants, Patients in the Intensive Care Unit (ICU), Patients with COPD |
Primary outcome
Change in Oxygen Radical Absorbance Capacity and day 5
Time frame: Baseline and day 5
Measurement of ORAC units, (Trolox mM eq) using The method used by the laboratory was AOAC 2012.23 Official Methods of Analysis, 21st Edition (2019)
3 secondary outcomes
Change in amino acids and day 5
Time frame: Baseline and day 5
Change in Vitamins and minerals
Time frame: Baseline and day 5
Change in Lipid profile and Apolipoproteins
Time frame: Baseline and day 5
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 22 Feb 2024.
- Background: PubMed 22849524Orozco-Levi M, Coronell C, Ramirez-Sarmiento A, Lloreta J, Martinez-Llorens J, Galdiz JB, Gea J. Injury of peripheral muscles in smokers with chronic obstructive pulmonary disease. Ultrastruct Pathol. 2012 Aug;36(4):228-38. doi: 10.3109/01913123.2012.668611.
- Results publication: PubMed 26623119Gea J, Pascual S, Casadevall C, Orozco-Levi M, Barreiro E. Muscle dysfunction in chronic obstructive pulmonary disease: update on causes and biological findings. J Thorac Dis. 2015 Oct;7(10):E418-38. doi: 10.3978/j.issn.2072-1439.2015.08.04.
- Results publication: PubMed 15117643Martinez-Llorens JM, Orozco-Levi M, Masdeu MJ, Coronell C, Ramirez-Sarmiento A, Sanjuas C, Broquetas JM, Gea J. [Global muscle dysfunction and exacerbation of COPD: a cohort study]. Med Clin (Barc). 2004 Apr 17;122(14):521-7. doi: 10.1016/s0025-7753(04)74294-3. Spanish.
- Results publication: PubMed 21636562Barreiro E, Ferrer D, Sanchez F, Minguella J, Marin-Corral J, Martinez-Llorens J, Lloreta J, Gea J. Inflammatory cells and apoptosis in respiratory and limb muscles of patients with COPD. J Appl Physiol (1985). 2011 Sep;111(3):808-17. doi: 10.1152/japplphysiol.01017.2010. Epub 2011 Jun 2.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Respiratory Function Loss and Sarcopenia, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
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 3 inclusion and 1 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 22 Feb 2024. 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 Colombia. 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?
Change in Oxygen Radical Absorbance Capacity and day 5 (time frame: Baseline and day 5). 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 NCT06248437, which also lists 4 linked publications.
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 22 Feb 2024.