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

NCT06248437 | Completed DMC

• 1 other identifier: HIC1-Nutra-2017
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Function Loss; Sarcopenia

Keywords

Antioxidant; Nutraceutical; Respiratory muscle; Peripheral muscle; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in amino acids and day 5

  Baseline and day 5

• Change in Vitamins and minerals

  Baseline and day 5

• Change in Lipid profile and Apolipoproteins

  Baseline and day 5

Study Arms (3)

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

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

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

Interventions

innovative nutraceutical-type food product that we designed called HIC1® from coffee mucilage OTHER

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

Also known as: Innovative nutraceutical-type food product that we designed called HIC1®

Healthy participants; Patients in the Intensive Care Unit (ICU); Patients with COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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-

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Fundación Cardiovascular de Colombia: lead
• Sanadores Ambientales SANAM Company SAS: collaborator

Study Sites (1)

Fundación Cardiovascular de Colombia

Floridablanca, Santander Department, 681004, Colombia

Location

Related Publications (4)

• 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.

  PMID: 22849524 BACKGROUND

• 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.

  PMID: 26623119 RESULT

• 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.

  PMID: 15117643 RESULT

• 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.

  PMID: 21636562 RESULT

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: March 30, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2021
• Last Updated: February 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)