NCT02581306

Brief Summary

If eligible to participate in the research study after completing the physical screening procedures, participants will be asked to return to the Substrate Metabolism Laboratory on another occasion after a short fast (no food or beverages - besides water) for at least 6 hours. After participants arrive, participants will rest quietly for approximately 30 min. The investigators will then collect a blood sample from a vein in participants hand, or forearm. After obtaining a baseline blood sample, participants will exercise at a moderate intensity (on a treadmill or a stationary bike) for one hour. This one hour moderate exercise session will feel like a slow jog during which participants would be able to carry a conversation. In order for the investigators to measure energy expended and the amount of fat participants are burning during exercise, the investigators will periodically ask participants to breathe through a mouthpiece so the investigators can collect participants expired breath. After the exercise session the investigators will collect another blood sample from a vein in participants hand, or forearm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Oct 2015

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

October 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2016

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

October 13, 2015

Last Update Submit

March 18, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • changes in plasma concentrations of epinephrine after a session of exercise

    Plasma levels will be measured using appropriate commercially available assays.

    1 day

  • changes in plasma concentrations of lactate after a session of exercise

    Plasma levels will be measured using appropriate commercially available assays.

    1 day

  • changes in plasma concentrations of fatty acids after a session of exercise

    Plasma levels will be measured using appropriate commercially available assays.

    1 day

  • changes in plasma concentrations of IL-6 after a session of exercise

    Plasma levels will be measured using appropriate commercially available assays.

    1 day

  • changes in plasma concentrations of irisin after a session of exercise

    Plasma levels will be measured using appropriate commercially available assays.

    1 day

  • changes in plasma concentrations of growth hormone after a session of exercise

    Plasma levels will be measured using appropriate commercially available assays.

    1 day

Study Arms (1)

Exercise session

OTHER

All subjects will exercise for 1 hour at a moderate intensity. There are no different arms in this study

Other: Exercise session

Interventions

There is no drug or device intervention in this study. Subjects will exercise at a moderate intensity for 60 minutes and a blood sample will be obtained before and after the exercise session

Exercise session

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-40
  • Body Mass Index: 20-35 kg/m2
  • Women must have regularly occurring menses and must be premenopausal

You may not qualify if:

  • Pregnant or lactating
  • Evidence/history of cardiovascular or metabolic disease
  • Medications known to affect lipid or glucose metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Movement Science and Director, Substrate Metabolism Laboratory

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 20, 2015

Study Start

October 1, 2015

Primary Completion

May 11, 2016

Study Completion

May 11, 2016

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations