Prototype of Innovative Food Product to Improve Respiratory and Peripheral Muscle Function in Humans

Sarcopenia Clinical Trial

— HIC1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06248437
• Other study ID #: HIC1-Nutra-2017
• Status: Completed
• Start date: March 30, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: January 2024
• Source: Fundación Cardiovascular de Colombia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with COPD

• patients receiving mechanical ventilation in the Intensive Care Unit (ICU)

• Age = 18 years

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Respiratory Function Loss
• Sarcopenia

Intervention

Other:
• innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilage
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

Locations

Country	Name	City	State
Colombia	Fundación Cardiovascular de Colombia	Floridablanca	Santander

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Cardiovascular de Colombia	Sanadores Ambientales SANAM Company SAS

Country where clinical trial is conducted

Colombia, 

References & Publications (4)

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/japplph — View 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. — View 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)74 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline and day 5
Secondary	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	Baseline and day 5
Secondary	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	Baseline and day 5
Secondary	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	Baseline and day 5