Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248437
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2024-01-31
Brief Title:
Prototype of Innovative Food Product to Improve Respiratory and Peripheral Muscle Function in Humans
Sponsor:
Fundación Cardiovascular de Colombia
Organization:
Fundación Cardiovascular de Colombia
Study Overview
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
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIC1
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
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 4926 water 2176 L-glutamine 11 beta-alanine 707 magnesium chloride 29 citric acid 148 natural blackberry flavor 13 milk protein extract 123 soy protein 122 tricalcium phosphate 106 nutrient supplement 1 sodium citrate 03 ascorbic acid 015 Stevia 011 sucralose 011 leucine 005 and vitamin D 0000027
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 201223 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 SerumPlasma 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
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 4926 water 2176 L-glutamine 11 beta-alanine 707 magnesium chloride 29 citric acid 148 natural blackberry flavor 13 milk protein extract 123 soy protein 122 tricalcium phosphate 106 nutrient supplement 1 sodium citrate 03 ascorbic acid 015 Stevia 011 sucralose 011 leucine 005 and vitamin D 0000027
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 201223 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 SerumPlasma 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None