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HealthyNCT02408510

Pilot Project to Examine the Effects of Exercise on Nocturnal Lipolysis in Men and Women

An observational study of Healthy, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
15 participants
Where
1 siteUnited States
Study dates
Aug 2015to Sep 2017
Phase
Observational
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 20 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Healthy Adults

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 21Show fewer
  • 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,
  • thyroid stimulating hormone <0.5 or >5.0 uU/ml,
  • hemoglobin < 14.5 g/dl men, <12.3 g/dl women,
  • alanine amino transferase > 47 U/l,
  • aspartate aminotransferase > 47 U/l,
  • alkaline phosphatase <39 or >117 U/l, or
  • creatinine >1.1 mg/dl.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Hospital

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read the detailed description

This primary goal of this pilot project is to obtain preliminary data demonstrating the feasibility of measuring lipolysis and fat oxidation during sleep in adult human subjects using microdialysis, stable isotope labeling techniques, and whole-room indirect calorimetry. The results of this study will be used in grant applications to perform definitive studies using these methods. The long term goal of this line of research is to explore the mechanisms responsible for sex based differences in the effectiveness of physical activity as an approach to weight loss. Previous longitudinal data have shown that in normal weight and obese individuals, for any given increase in physical activity, there is a significantly greater loss of fat mass in men relative to women [Westerterp, 1997]. These data need to be reconciled, however, with the wealth of data demonstrating that during exercise, women release and oxidize fat more readily than men [Horton, 2009; Horton 1998, Moro 2007]. This phenomenon seems counterintuitive, given that men have less body fat than women and are able to lose more body fat than women when beginning a weight loss program [Bjorntorp, 2007]. Recent data suggests a mechanism to explain this paradox. Specifically, in obese subjects, 24-hour fat oxidation increased following a daytime bout of exercise, and this increase occurred in men only and was driven by a significant increase in fat oxidation not during the day but rather during sleep the night following exercise [Bergouignan, 2014]. Since the predominant source of fuel during sleep is free fatty acids (FFA) released from adipose tissue (i.e., lipolysis), it may be that enhanced sleeping lipolysis is a key factor in how exercise stimulates fat oxidation and thus greater fat loss in males vs. females over time.

The primary objective of the proposed study is to demonstrate the feasibility of measuring nocturnal whole-body and regional lipolysis by using stable isotope techniques and microdialysis of subcutaneous abdominal adipose tissue respectively with the long term goal of determining the effects of acute exercise during the daytime on rates of lipolysis at night in men and women. A secondary objective of this study is to determine if nocturnal regional lipolysis measured by microdialysis of subcutaneous abdominal adipose tissue and whole body lipolysis measured by a stable glycerol isotope infusion are related to dietary and whole body fat oxidation measured by stable isotope labelled fatty acid and whole-room calorimetry, respectively. Finally, the study aims to determine if sleep quality parameters measured by EEG and wrist actigraphy correlate with measures of nocturnal fat oxidation and lipolysis (regional and whole body)

Conditions
Healthy
Keywords
Volunteers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Lipolysis

    Measured using stable isotope tracers and microdialysis

    Measured: Overnight (2200h-0700h)

  2. Change in Substrate Oxidation

    Measured using whole-room calorimetry

    Measured: 24 hours

Secondary outcomes (2)

  1. Change in Sleep Quality

    Measured using wrist actigraphy

    Measured: Overnight (2200h-0700h)

  2. Change in Lipolytic Hormones

    Frequent blood sampling to measure growth hormone, cortisol, catecholamines, and other lipolytic hormones

    Measured: Overnight (2200h-0700h)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02408510
Sponsor's protocol ID
13-0359
Status last verified
Jun 2019
First submitted
30 Mar 2015
Last updated
1 Jul 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 9080256

  • 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.

    PubMed 19407251

  • 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.

    PubMed 9804587

  • 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.

    PubMed 17890493

  • 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.

    PubMed 2655420

  • 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.

    PubMed 24714529

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by University of Colorado, Denver at 1 site in United States.

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 7 inclusion and 21 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: finished, as of the sponsor's last update on 1 Jul 2019. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lipolysis (time frame: Overnight (2200h-0700h)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02408510, which also lists 6 linked publications.

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 1 Jul 2019.

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