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临床试验/NCT06248437
NCT06248437已完成不适用

Undertaking for the Sensory, Functional and Stability Validation of an Innovative Food Product Prototype to Improve Respiratory and Peripheral Muscle Function in Humans

Fundación Cardiovascular de Colombia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Change in Oxygen Radical Absorbance Capacity and day 5

研究概览

简要总结

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.

详细描述

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%).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Change in Oxygen Radical Absorbance Capacity and day 5

时间窗: Baseline 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)

次要结局

  • Change in Vitamins and minerals(Baseline and day 5)
  • Change in Lipid profile and Apolipoproteins(Baseline and day 5)
  • Change in amino acids and day 5(Baseline and day 5)

研究者

发起方
Fundación Cardiovascular de Colombia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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