Clinical trial NCT06248437: Prototype of Innovative Food Product to Improve Respiratory and Peripheral Muscle Function in Humans
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Function Loss
Sarcopenia
Keywords: Antioxidant
Nutraceutical
Respiratory muscle
Peripheral muscle
Sarcopenia
Lead sponsor: Fundación Cardiovascular de Colombia
Sponsor class: OTHER
Collaborators: name: Sanadores Ambientales SANAM Company SAS
First posted: 2024-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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-

Brief 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.

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:

1. 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)
2. Amino acids. Twenty-three amino acids were quantified in Serum/Plasma with the Gas Chromatography technique with flame ionization detector.
3. 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.
4. 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.

Eligibility criteria: Inclusion Criteria:

* patients with COPD
* patients receiving mechanical ventilation in the Intensive Care Unit (ICU)
* Age ≥ 18 years

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in Oxygen Radical Absorbance Capacity and day 5
timeFrame: Baseline and day 5
Secondary outcomes:
measure: Change in amino acids and day 5
timeFrame: Baseline and day 5
measure: Change in Vitamins and minerals
timeFrame: Baseline and day 5
measure: Change in Lipid profile and Apolipoproteins
timeFrame: Baseline and day 5
Other outcomes:
Locations:
city: Floridablanca
country: Colombia
facility: Fundación Cardiovascular de Colombia
state: Santander
Study officials:
References:
citation: 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.
citation: Gea 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.
citation: Martinez-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.
citation: Barreiro 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.