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

March 24, 2020 updated by: Jonatan Ruiz Ruiz, Universidad de Granada

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

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.).

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meal with medium chain triglycerdies first
Arm 1: participants randomized to receive the mixed meal with medium chain triglycerides first.
Mixed macronutrient liquid meal (1.6kcal/ml, 15% protein, 47% carbohydrates, 35% fat, 3% fiber) with medium chain triglycerides (3g/100 kcal). An amount with energy supply equivalent to their 50% basal metabolic rate.
Mixed macronutrient liquid meal (1.6kcal/ml, 15% protein, 47% carbohydrates, 35% fat, 3% fiber) without medium chain triglycerides (replaced it with long chain triglycerides). An amount with energy supply equivalent to their 50% basal metabolic rate.
Active Comparator: Meal with medium chain triglycerdies second
Arm 2: participants randomized to receive the mixed meal without medium chain triglycerides first.te
Mixed macronutrient liquid meal (1.6kcal/ml, 15% protein, 47% carbohydrates, 35% fat, 3% fiber) with medium chain triglycerides (3g/100 kcal). An amount with energy supply equivalent to their 50% basal metabolic rate.
Mixed macronutrient liquid meal (1.6kcal/ml, 15% protein, 47% carbohydrates, 35% fat, 3% fiber) without medium chain triglycerides (replaced it with long chain triglycerides). An amount with energy supply equivalent to their 50% basal metabolic rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-prandial nutrient oxidation
Time Frame: 4 hours
Fat or carbohydrate oxidation measured by indrect calorimetry
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-prandial blood glucose concentrations
Time Frame: 4 hours
Measures of blood glucose concentrations
4 hours
Post-prandial blood insulin concentrations
Time Frame: 4 hours
Measures of blood insulin concentrations
4 hours
Post-prandial blood non-esterified fatty acid concentrations
Time Frame: 4 hours
Measures of blood non-esterified fatty acid concentrations
4 hours
Post-prandial blood tryglicerides concentrations
Time Frame: 4 hours
Measures of blood tryglicerides concentrations
4 hours
Post-prandial blood cholesterol concentrations
Time Frame: 4 hours
Measures of blood cholesterol concentrations
4 hours
Post-prandial blood glycerol concentrations
Time Frame: 4 hours
Measures of blood glycerol concentrations
4 hours
Post-prandial blood lactate concentrations
Time Frame: 4 hours
Measures of blood lactate concentrations
4 hours
Post-prandial energy expenditure
Time Frame: 4 hours
Measured by indrect calorimetry
4 hours
Post-prandial sensations related to appetite
Time Frame: 4 hours
Measured by visual analogue scales (VAS). Score ranging from 0 to 100mm. Higher values mean the most positive rating, while lower values mean the most negative rating.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jonatan Ruiz Ruiz, Dr., Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2020

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • nº 1102/CEIH/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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