Metabolic SyndromeNCT04321018
Effect of a Mixed Macronutritional Meal With Medium Chain Triglycerides on the Oxidation of Postprandial Macronutrients
A study testing Mixed meal with medium chain triglycerides and Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides in people with Metabolic Syndrome, run by Universidad de Granada at 1 site in Spain.
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.). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Mixed meal with medium chain triglycerides and Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2020to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Lucas Jurado Fasoli, PhD student contact
Spain1 site, 1 recruiting
- Recruiting
Jonatan Ruiz Ruiz
Granada, 18011
Jonatan Ruiz Ruiz, Dr, ruizj@ugr.es
Lucas Jurado Fasoli, PhD student, juradofasoli@ugr.es
About this study
Official title: 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.).
Read the 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
- Conditions
- Metabolic Syndrome
- Being tested
- Mixed meal with medium chain triglycerides, Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed meal with medium chain triglyceridesDietary 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 trygliceridesDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Meal with medium chain triglycerdies first | Experimental | Arm 1: participants randomized to receive the mixed meal with medium chain triglycerides first. Receives: Dietary Supplement: Mixed meal with medium chain triglycerides; Dietary Supplement: Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides |
| Meal with medium chain triglycerdies second | Active comparator | Arm 2: participants randomized to receive the mixed meal without medium chain triglycerides first.te Receives: Dietary Supplement: Mixed meal with medium chain triglycerides; Dietary Supplement: Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial nutrient oxidation
Fat or carbohydrate oxidation measured by indrect calorimetry
Measured: 4 hours
Secondary outcomes (9)
Post-prandial blood glucose concentrations
Measures of blood glucose concentrations
Measured: 4 hours
Post-prandial blood insulin concentrations
Measures of blood insulin concentrations
Measured: 4 hours
Post-prandial blood non-esterified fatty acid concentrations
Measures of blood non-esterified fatty acid concentrations
Measured: 4 hours
Post-prandial blood tryglicerides concentrations
Measures of blood tryglicerides concentrations
Measured: 4 hours
Post-prandial blood cholesterol concentrations
Measures of blood cholesterol concentrations
Measured: 4 hours
Post-prandial blood glycerol concentrations
Measures of blood glycerol concentrations
Measured: 4 hours
Post-prandial blood lactate concentrations
Measures of blood lactate concentrations
Measured: 4 hours
Post-prandial energy expenditure
Measured by indrect calorimetry
Measured: 4 hours
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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start15 Feb 2020
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonatan Ruiz Ruiz, Universidad de Granada
- Investigators
- Jonatan Ruiz Ruiz, Dr., Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321018
- Sponsor's protocol ID
- nº 1102/CEIH/2020
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Addition of Medium Chain Triglycerides to a Mixed Macronutritional Meal on the Oxidation of Postprandial Macronutrients
- ClinicalTrials.gov ID
- NCT04321018
- Acronym / sponsor ID
- nº 1102/CEIH/2020
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Meal with medium chain triglycerdies first | Experimental | Dietary Supplement: Mixed meal with medium chain triglycerides, Dietary Supplement: Mixed meal with the replacement of medium chain triglycerides with unsaturated trygliceridesArm 1: participants randomized to receive the mixed meal with medium chain triglycerides first. |
| Meal with medium chain triglycerdies second | Active comparator | Dietary Supplement: Mixed meal with medium chain triglycerides, Dietary Supplement: Mixed meal with the replacement of medium chain triglycerides with unsaturated trygliceridesArm 2: participants randomized to receive the mixed meal without medium chain triglycerides first.te |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed meal with medium chain triglyceridesMixed 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. | Dietary supplement | Meal with medium chain triglycerdies first, Meal with medium chain triglycerdies second |
| Mixed meal with the replacement of medium chain triglycerides with unsaturated trygliceridesMixed 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. | Dietary supplement | Meal with medium chain triglycerdies first, Meal with medium chain triglycerdies second |
Primary outcome
Post-prandial nutrient oxidation
Time frame: 4 hours
Fat or carbohydrate oxidation measured by indrect calorimetry
9 secondary outcomes
Post-prandial blood glucose concentrations
Time frame: 4 hours
Post-prandial blood insulin concentrations
Time frame: 4 hours
Post-prandial blood non-esterified fatty acid concentrations
Time frame: 4 hours
Post-prandial blood tryglicerides concentrations
Time frame: 4 hours
Post-prandial blood cholesterol concentrations
Time frame: 4 hours
Post-prandial blood glycerol concentrations
Time frame: 4 hours
Post-prandial blood lactate concentrations
Time frame: 4 hours
Post-prandial energy expenditure
Time frame: 4 hours
Post-prandial sensations related to appetite
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas Jurado Fasoli, PhD student contact
Jonatan Ruiz Ruiz, Dr. principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed meal with medium chain triglycerides and Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides in people with Metabolic Syndrome, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonatan Ruiz Ruiz, Dr. (958242754 ext. 34, ruizj@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-prandial nutrient oxidation (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.