Prototype of Innovative Food Product to Improve Respiratory and Peripheral Muscle Function in Humans — HIC1  

Sarcopenia Clinical Trial

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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Respiratory Function Loss
• Sarcopenia

• NCT number: NCT06248437
• Study type: Observational
• Source: Fundación Cardiovascular de Colombia
• Status: Completed
• Start date: March 30, 2019
• Completion date: March 30, 2021