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

Primary Purpose

Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mixed meal with medium chain triglycerides
Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Jonatan Ruiz RuizRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Meal with medium chain triglycerdies first

Meal with medium chain triglycerdies second

Arm Description

Arm 1: participants randomized to receive the mixed meal with medium chain triglycerides first.

Arm 2: participants randomized to receive the mixed meal without medium chain triglycerides first.te

Outcomes

Primary Outcome Measures

Post-prandial nutrient oxidation
Fat or carbohydrate oxidation measured by indrect calorimetry

Secondary Outcome Measures

Post-prandial blood glucose concentrations
Measures of blood glucose concentrations
Post-prandial blood insulin concentrations
Measures of blood insulin concentrations
Post-prandial blood non-esterified fatty acid concentrations
Measures of blood non-esterified fatty acid concentrations
Post-prandial blood tryglicerides concentrations
Measures of blood tryglicerides concentrations
Post-prandial blood cholesterol concentrations
Measures of blood cholesterol concentrations
Post-prandial blood glycerol concentrations
Measures of blood glycerol concentrations
Post-prandial blood lactate concentrations
Measures of blood lactate concentrations
Post-prandial energy expenditure
Measured by indrect calorimetry
Post-prandial sensations related to appetite
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.

Full Information

First Posted
March 19, 2020
Last Updated
March 24, 2020
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT04321018
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meal with medium chain triglycerdies first
Arm Type
Experimental
Arm Description
Arm 1: participants randomized to receive the mixed meal with medium chain triglycerides first.
Arm Title
Meal with medium chain triglycerdies second
Arm Type
Active Comparator
Arm Description
Arm 2: participants randomized to receive the mixed meal without medium chain triglycerides first.te
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixed meal with medium chain triglycerides
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-prandial nutrient oxidation
Description
Fat or carbohydrate oxidation measured by indrect calorimetry
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Post-prandial blood glucose concentrations
Description
Measures of blood glucose concentrations
Time Frame
4 hours
Title
Post-prandial blood insulin concentrations
Description
Measures of blood insulin concentrations
Time Frame
4 hours
Title
Post-prandial blood non-esterified fatty acid concentrations
Description
Measures of blood non-esterified fatty acid concentrations
Time Frame
4 hours
Title
Post-prandial blood tryglicerides concentrations
Description
Measures of blood tryglicerides concentrations
Time Frame
4 hours
Title
Post-prandial blood cholesterol concentrations
Description
Measures of blood cholesterol concentrations
Time Frame
4 hours
Title
Post-prandial blood glycerol concentrations
Description
Measures of blood glycerol concentrations
Time Frame
4 hours
Title
Post-prandial blood lactate concentrations
Description
Measures of blood lactate concentrations
Time Frame
4 hours
Title
Post-prandial energy expenditure
Description
Measured by indrect calorimetry
Time Frame
4 hours
Title
Post-prandial sensations related to appetite
Description
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.
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonatan Ruiz Ruiz, Dr.
Phone
958242754
Ext
34
Email
ruizj@ugr.es
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas Jurado Fasoli, PhD student
Email
juradofasoli@ugr.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonatan Ruiz Ruiz, Dr.
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonatan Ruiz Ruiz
City
Granada
ZIP/Postal Code
18011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonatan Ruiz Ruiz, Dr
Email
ruizj@ugr.es
First Name & Middle Initial & Last Name & Degree
Lucas Jurado Fasoli, PhD student
Email
juradofasoli@ugr.es

12. IPD Sharing Statement

Plan to Share IPD
No

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

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