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临床试验/NCT04321018
NCT04321018Unknown不适用

Effect of the Addition of Medium Chain Triglycerides to a Mixed Macronutritional Meal on the Oxidation of Postprandial Macronutrients

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年2月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Post-prandial nutrient oxidation

研究概览

简要总结

The main aim of this study is to determine the effect of the addition of medium chain triglycerides to a mixed macro nutritional meal on postprandial macronutrients oxidation (i.e. fat oxidation, carbohydrate oxidation, change in respiratory quotient, peak respiratory quotient, etc.).

详细描述

A mixed meal characterized by a high quantity of carbohydrates could develop an increment in the postprandial carbohydrate oxidation. Medium chain triglycerides could be absorbed and metabolized immediately. It is plausible that its addition to a mixed meal unchains the decrement in the carbohydrate oxidation and increment in fat oxidation. If this hypothesis it is correct, its lower postprandial carbohydrate oxidation could develop a higher postprandial exposure to hyperglycemia, being of clinical interest.

20 young adults will be randomized into two conditions (experimental and control conditions) with 7 days of separation between conditions. Each evaluation day will conform to the following tests:

  1. Basal metabolic rate assessment through indirect calorimetry.
  2. Intake of the corresponding mixed meal (experimental or control)
  3. Postprandial nutrient oxidation and energy expenditure through indirect calorimetry
  4. Blood samples assessment in 9 time points during the evaluation day.
  5. Post-prandial sensations related to appetite in 11 time points during the evaluation day

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy male or female
  • Ages 18-30 years
  • BMI: 18-27.5 kg/m2
  • Stable weight over the last 3 months (body weight changes<35kg)
  • Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols.

排除标准

  • History of cardiovascular disease
  • Diabetes or hypertension
  • Pregnant, planning to become pregnant, or breastfeeding
  • Have been treated previously or during the study period with prescription drugs: antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results.
  • Hematological pathology
  • Have had a blood transfusion or severe blood loss within the last 3 months
  • Allergy/intolerance to milk proteins, fish, soy, and/or any ingredient of the mixed meal
  • Any non-controlled medical condition which could influence results or could be worsened by the participation in the study
  • Claustrophobia
  • Needle phobia
  • Are deemed unsuitable by the investigator for any other reason, that prevent data collection.

结局指标

主要结局

Post-prandial nutrient oxidation

时间窗: 4 hours

Fat or carbohydrate oxidation measured by indrect calorimetry

次要结局

  • Post-prandial sensations related to appetite(4 hours)
  • Post-prandial blood insulin concentrations(4 hours)
  • Post-prandial blood cholesterol concentrations(4 hours)
  • Post-prandial blood lactate concentrations(4 hours)
  • Post-prandial blood non-esterified fatty acid concentrations(4 hours)
  • Post-prandial blood tryglicerides concentrations(4 hours)
  • Post-prandial blood glycerol concentrations(4 hours)
  • Post-prandial energy expenditure(4 hours)
  • Post-prandial blood glucose concentrations(4 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonatan Ruiz Ruiz

Associate professor

Universidad de Granada

研究点 (2)

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