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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Respiratory Function Loss
• Intervention / Treatment: Other: innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilage

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Colombia
  • Santander
    • Floridablanca, Santander, Colombia, 681004
      • Fundacion Cardiovascular de Colombia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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-

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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; Other Names: Innovative nutraceutical-type food product that we designed called HIC1®
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.	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; Other Names: Innovative nutraceutical-type food product that we designed called HIC1®
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	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; Other Names: Innovative nutraceutical-type food product that we designed called HIC1®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Fundación Cardiovascular de Colombia
• Collaborators: Sanadores Ambientales SANAM Company SAS

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Sarcopenia; Nutraceutical; Antioxidant; Respiratory muscle; Peripheral muscle
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: HIC1-Nutra-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No