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

NCT06248437 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-02-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Sanadores Ambientales SANAM Company SAS

    collaborator UNKNOWN
  • Fundación Cardiovascular de Colombia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-30
Primary Completion
2020-03-30
Completion
2021-03-30

Countries

  • Colombia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06248437 on ClinicalTrials.gov