- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04321018
Effect of a Mixed Macronutritional Meal With Medium Chain Triglycerides on the Oxidation of Postprandial Macronutrients
Effect of the Addition of Medium Chain Triglycerides to a Mixed Macronutritional Meal on the Oxidation of Postprandial Macronutrients
Study Overview
Status
Conditions
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lucas Jurado Fasoli, PhD student
- Email: juradofasoli@ugr.es
Study Locations
-
-
-
Granada, Spain, 18011
- Recruiting
- Jonatan Ruiz Ruiz
-
Contact:
- Jonatan Ruiz Ruiz, Dr
- Email: ruizj@ugr.es
-
Contact:
- Lucas Jurado Fasoli, PhD student
- Email: juradofasoli@ugr.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Jonatan Ruiz Ruiz, Dr., Universidad de Granada
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- nº 1102/CEIH/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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