NCT04320433

Brief Summary

The main aim of this study is to determine the inter-day reliability, by using indirect calorimetry, of the post-prandial macronutrient oxidation and energy expenditure after consuming oral glucose load solution.

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 Apr 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

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
7 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day 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

3 months

First QC Date

March 19, 2020

Last Update Submit

March 22, 2020

Conditions

Glucose Intolerance

Outcome Measures

Primary Outcomes (1)

  • Inter-day reliability, 7 days apart, in post-prandial nutrient oxidation

    Reliability

    7 days

Secondary Outcomes (2)

  • Inter-day reliability, 7 days apart, in post-prandial energy expenditure

    7 days

  • Inter-day reliability, 7 days apart, in glucose levels

    7 days

Other Outcomes (1)

  • • Reliability of the O2 and CO2 metabolic cart sensors by pure gases infusions using a high-precision mass-flow controllers

    Immediately after the participants' gas exhange measurements

Study Arms (1)

Experimental

EXPERIMENTAL

Participants will undergo two trials visit (with a week of separation). During the visits they will ingest an oral glucose load solution (oral glucose tolerance test) and gas exchange will be measured over the following 3-hours. The glucose levels will be monitored through a Glucose meter in different time frames.

Diagnostic Test: Oral glucose tolerance test

Interventions

Oral glucose tolerance testDIAGNOSTIC_TEST

Participants will ingest 75g anhydrous glucose dissolved in a volume of 200mL of water (NUTER.TEC GLUCOS, Subra, Toulouse, France).

Experimental

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.
  • 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

Related Publications (1)

  • Alcantara JMA, Sanchez-Delgado G, Jurado-Fasoli L, Galgani JE, Labayen I, Ruiz JR. Reproducibility of the energy metabolism response to an oral glucose tolerance test: influence of a postcalorimetric correction procedure. Eur J Nutr. 2023 Feb;62(1):351-361. doi: 10.1007/s00394-022-02986-w. Epub 2022 Aug 25.

    PMID: 36006468DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • juanma.alcantara@hotmail.com Ruiz Ruiz, Dr.

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonatan Ruiz Ruiz, Dr.

CONTACT

958242754ruizj@ugr.es

Juan Manuel Alcantara, PhD student

CONTACT

juanma.alcantara@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
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

April 1, 2020

Primary Completion

July 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)