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Clinical Trials/NCT04321018
NCT04321018UnknownNot Applicable

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

Universidad de Granada2 sites in 1 country20 target enrollmentStarted: February 15, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
2
Primary Endpoint
Post-prandial nutrient oxidation

Study Overview

Brief Summary

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.).

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Post-prandial nutrient oxidation

Time Frame: 4 hours

Fat or carbohydrate oxidation measured by indrect calorimetry

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jonatan Ruiz Ruiz

Associate professor

Universidad de Granada

Study Sites (2)

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