Clinical trial NCT04321018: Effect of a Mixed Macronutritional Meal With Medium Chain Triglycerides on the Oxidation of Postprandial Macronutrients
Official title: Effect of the Addition of Medium Chain Triglycerides to a Mixed Macronutritional Meal on the Oxidation of Postprandial Macronutrients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Post-prandial nutrient oxidation
timeFrame: 4 hours
Secondary outcomes:
measure: Post-prandial blood glucose concentrations
timeFrame: 4 hours
measure: Post-prandial blood insulin concentrations
timeFrame: 4 hours
measure: Post-prandial blood non-esterified fatty acid concentrations
timeFrame: 4 hours
measure: Post-prandial blood tryglicerides concentrations
timeFrame: 4 hours
measure: Post-prandial blood cholesterol concentrations
timeFrame: 4 hours
measure: Post-prandial blood glycerol concentrations
timeFrame: 4 hours
measure: Post-prandial blood lactate concentrations
timeFrame: 4 hours
measure: Post-prandial energy expenditure
timeFrame: 4 hours
measure: Post-prandial sensations related to appetite
timeFrame: 4 hours
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Jonatan Ruiz Ruiz
Study officials:
affiliation: Universidad de Granada
name: Jonatan Ruiz Ruiz, Dr.
role: PRINCIPAL_INVESTIGATOR
References: