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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04321018
• Other study ID #: nº 1102/CEIH/2020
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: July 2020

Study information

• Verified date: March 2020
• Source: Universidad de Granada
• Contact: Jonatan Ruiz Ruiz, Dr.
• Phone: 958242754
• Email: ruizj[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome

Intervention

Dietary Supplement:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Jonatan Ruiz Ruiz	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-prandial nutrient oxidation	Fat or carbohydrate oxidation measured by indrect calorimetry	4 hours
Secondary	Post-prandial blood glucose concentrations	Measures of blood glucose concentrations	4 hours
Secondary	Post-prandial blood insulin concentrations	Measures of blood insulin concentrations	4 hours
Secondary	Post-prandial blood non-esterified fatty acid concentrations	Measures of blood non-esterified fatty acid concentrations	4 hours
Secondary	Post-prandial blood tryglicerides concentrations	Measures of blood tryglicerides concentrations	4 hours
Secondary	Post-prandial blood cholesterol concentrations	Measures of blood cholesterol concentrations	4 hours
Secondary	Post-prandial blood glycerol concentrations	Measures of blood glycerol concentrations	4 hours
Secondary	Post-prandial blood lactate concentrations	Measures of blood lactate concentrations	4 hours
Secondary	Post-prandial energy expenditure	Measured by indrect calorimetry	4 hours
Secondary	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.	4 hours