NCT02408510

Brief Summary

The goal of this proof of concept/feasibility study is to use rigorous methodology to explore links between daytime energy status and nocturnal fat metabolism in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Typical duration 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

First Submitted

Initial submission to the registry

March 30, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 1, 2019

Status Verified

June 1, 2019

Enrollment Period

2.1 years

First QC Date

March 30, 2015

Last Update Submit

June 27, 2019

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (2)

  • Change in Lipolysis

    Measured using stable isotope tracers and microdialysis

    Overnight (2200h-0700h)

  • Change in Substrate Oxidation

    Measured using whole-room calorimetry

    24 hours

Secondary Outcomes (2)

  • Change in Sleep Quality

    Overnight (2200h-0700h)

  • Change in Lipolytic Hormones

    Overnight (2200h-0700h)

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy Adults

You may qualify if:

  • Males and Females, 20-35 years of age
  • Sedentary (planned exercise \< 3 d/week, \< 30 min/session)
  • Lifetime maximum BMI of 30 kg/m2
  • Weight stable by self-report for at least 2 mo before the study (\<5% weight change)
  • Habitual sleeping pattern of \>7 hours not to exceed 9.25 hours of sleep per night
  • Zero to low-moderate caffeine intake (not to exceed 500 mg/d)
  • Alcohol use fewer than two standard drinks per day per week for males and one or less drinks per day per week for females.

You may not qualify if:

  • Current smoker
  • Use of any medication that could affect lipid metabolism, insulin signaling, or sleep
  • Pregnant women will not be enrolled in the study
  • Current or chronic medical/psychiatric conditions
  • Shift work or dwelling below Denver altitude (1,600 m) a year prior to testing
  • Travel across more than one time zone 3 wk before study
  • Abnormal eating patterns identified by interview and eating questionnaire
  • Screening positive for illicit drugs
  • Chronic health conditions such as diabetes,
  • Hyper or hypothyroidism
  • Sleep apnea (Apnea-Hypopnea Index \>5)
  • Renal or liver disease, anemia, or cancer
  • Regularly go to sleep after midnight
  • One or more of the following out-of-range values measured on a fasting blood sample:
  • glucose \> 110 mg/dl,
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (6)

  • Westerterp KR, Goran MI. Relationship between physical activity related energy expenditure and body composition: a gender difference. Int J Obes Relat Metab Disord. 1997 Mar;21(3):184-8. doi: 10.1038/sj.ijo.0800385.

    PMID: 9080256BACKGROUND

  • Horton TJ, Dow S, Armstrong M, Donahoo WT. Greater systemic lipolysis in women compared with men during moderate-dose infusion of epinephrine and/or norepinephrine. J Appl Physiol (1985). 2009 Jul;107(1):200-10. doi: 10.1152/japplphysiol.90812.2008. Epub 2009 Apr 30.

    PMID: 19407251BACKGROUND

  • Horton TJ, Pagliassotti MJ, Hobbs K, Hill JO. Fuel metabolism in men and women during and after long-duration exercise. J Appl Physiol (1985). 1998 Nov;85(5):1823-32. doi: 10.1152/jappl.1998.85.5.1823.

    PMID: 9804587BACKGROUND

  • Moro C, Pillard F, de Glisezinski I, Crampes F, Thalamas C, Harant I, Marques MA, Lafontan M, Berlan M. Sex differences in lipolysis-regulating mechanisms in overweight subjects: effect of exercise intensity. Obesity (Silver Spring). 2007 Sep;15(9):2245-55. doi: 10.1038/oby.2007.267.

    PMID: 17890493BACKGROUND

  • Bjorntorp PA. Sex differences in the regulation of energy balance with exercise. Am J Clin Nutr. 1989 May;49(5 Suppl):958-61. doi: 10.1093/ajcn/49.5.958. No abstract available.

    PMID: 2655420BACKGROUND

  • Bergouignan A, Kealey EH, Schmidt SL, Jackman MR, Bessesen DH. Twenty-four hour total and dietary fat oxidation in lean, obese and reduced-obese adults with and without a bout of exercise. PLoS One. 2014 Apr 8;9(4):e94181. doi: 10.1371/journal.pone.0094181. eCollection 2014.

    PMID: 24714529BACKGROUND

Study Officials

  • Daniel Bessesen, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 3, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

July 1, 2019

Record last verified: 2019-06

Locations

US(1)