NCT01938794

Brief Summary

Accurately measuring how many calories a person burns each day is difficult to do. Researchers can do this with a technique called doubly labeled water (DLW). This involves drinking water that is "labeled" with a non-radioactive tracer. After a few hours, the labeled water can be detected in the urine. To measure how many calories are burned (Total daily energy expenditure, TDEE), urine samples are collected several days apart. Although this technique is accurate, it is also challenging for two reasons. First, the labeled water is expensive. Second, the urine samples are analyzed using equipment (Isotope Ratio Mass Spectrometer, or IRMS) that is expensive and difficult to operate. The goal of this project is to develop a new instrument to perform DLW measurements of TDEE. This instrument, called a triple isotope water analyzer (TIWA) is less expensive and easier to operate than IRMS. Additionally, since the TIWA is more accurate than IRMS, it may potentially reduce the amount of labeled water required to measure TDEE, and thus reduce costs. The purpose of this study is to compare the accuracy of measuring TDEE from labeled water using the new instrument (TIWA) and from the traditional approach (IRMS). We will also compare the accuracy to the measurement of TDEE from whole-room indirect calorimetry (metabolic room), which is considered the most accurate way to measure TDEE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

4 years

First QC Date

September 5, 2013

Last Update Submit

October 7, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Daily energy expenditure

    7 days

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy adults (\>18 yrs)

You may qualify if:

  • Age \> 18yrs

You may not qualify if:

  • Smokers
  • weight \> 300 lbs
  • chronic disease (e.g. diabetes, heart disease, thyroid disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Melanson EL, Swibas T, Kohrt WM, Catenacci VA, Creasy SA, Plasqui G, Wouters L, Speakman JR, Berman ESF. Validation of the doubly labeled water method using off-axis integrated cavity output spectroscopy and isotope ratio mass spectrometry. Am J Physiol Endocrinol Metab. 2018 Feb 1;314(2):E124-E130. doi: 10.1152/ajpendo.00241.2017. Epub 2017 Oct 3.

Study Officials

  • Edward L Melanson, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 10, 2013

Study Start

September 1, 2013

Primary Completion

August 31, 2017

Study Completion

December 31, 2017

Last Updated

October 9, 2019

Record last verified: 2019-10

Locations