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

NCT ID: NCT04321018

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-15
• Study Completion Date: 2020-07-31

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

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Meal with medium chain triglycerdies first

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

Group Type: EXPERIMENTAL

Mixed meal with medium chain triglycerides

Intervention Type: DIETARY_SUPPLEMENT

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 meal with the replacement of medium chain triglycerides with unsaturated tryglicerides

Intervention Type: DIETARY_SUPPLEMENT

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.

Meal with medium chain triglycerdies second

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

Group Type: ACTIVE_COMPARATOR

Mixed meal with medium chain triglycerides

Intervention Type: DIETARY_SUPPLEMENT

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 meal with the replacement of medium chain triglycerides with unsaturated tryglicerides

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Mixed meal with medium chain triglycerides

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

Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides

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.

Intervention Type: DIETARY_SUPPLEMENT

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)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Jonatan Ruiz Ruiz

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonatan Ruiz Ruiz, Dr.

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Jonatan Ruiz Ruiz

Granada, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Jonatan Ruiz Ruiz, Dr.

Role: CONTACT

ruizj@ugr.es

958242754 ext. 34

Lucas Jurado Fasoli, PhD student

Role: CONTACT

juradofasoli@ugr.es

Facility Contacts

Jonatan Ruiz Ruiz, Dr

Role: primary

ruizj@ugr.es

Lucas Jurado Fasoli, PhD student

Role: backup

juradofasoli@ugr.es

Other Identifiers

nº 1102/CEIH/2020

Identifier Type: -

Identifier Source: org_study_id