NCT04321018

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.).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 19, 2020

Last Update Submit

March 24, 2020

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Post-prandial nutrient oxidation

    Fat or carbohydrate oxidation measured by indrect calorimetry

    4 hours

Secondary Outcomes (9)

  • Post-prandial blood glucose concentrations

    4 hours

  • Post-prandial blood insulin concentrations

    4 hours

  • Post-prandial blood non-esterified fatty acid concentrations

    4 hours

  • Post-prandial blood tryglicerides concentrations

    4 hours

  • Post-prandial blood cholesterol concentrations

    4 hours

  • +4 more secondary outcomes

Study Arms (2)

Meal with medium chain triglycerdies first

EXPERIMENTAL

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

Dietary Supplement: Mixed meal with medium chain triglyceridesDietary 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

Dietary Supplement: Mixed meal with medium chain triglyceridesDietary Supplement: Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides

Interventions

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.

Meal with medium chain triglycerdies firstMeal with medium chain triglycerdies second
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.

Meal with medium chain triglycerdies firstMeal with medium chain triglycerdies second

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonatan Ruiz Ruiz

Granada, 18011, Spain

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jonatan Ruiz Ruiz, Dr.

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonatan Ruiz Ruiz, Dr.

CONTACT

958242754ruizj@ugr.es

Lucas Jurado Fasoli, PhD student

CONTACT

juradofasoli@ugr.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Crossover Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 25, 2020

Study Start

February 15, 2020

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)