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Impact of Exercise on the Metabolic Consequences of Overeating (XO)

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Overeating Protocol
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 18-40
  • Body Mass Index: 20-30 kg/m2
  • Exercise group: (≥5 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities)
  • No Exercise group: no regularly planned exercise/physical activity
  • Women must have regularly occurring menses and must be premenopausal

Exclusion Criteria:

  • Pregnant or lactating
  • Blood pressure > 140/90 mm Hg
  • Evidence/history of cardiovascular or metabolic disease
  • Medications known to affect lipid or glucose metabolism
  • Tobacco or electronic cigarette user

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Overeating Protocol

Arm Description

Subjects will ingest 30% more calories per day than their calculated daily energy requirements (~750kcals extra energy intake each day). All subjects will be instructed (and will be guided) to consume a diet containing approximately 50% carbohydrate, 35% fat, and 15% protein.

Outcomes

Primary Outcome Measures

Oral Glucose Tolerance
An index of insulin sensitivity will be measured using the plasma insulin and glucose concentrations during the 3h OGTT

Secondary Outcome Measures

Resting Metabolic Rate
Total Cholesterol
Plasma concentrations of total- cholesterol will be measured
PPARg mRNA expression
cytokine proteins will be measured in adipose tissue

Full Information

First Posted
January 21, 2016
Last Updated
March 18, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02701738
Brief Title
Impact of Exercise on the Metabolic Consequences of Overeating
Acronym
XO
Official Title
Impact of Exercise on the Metabolic Consequences of Overeating
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 12, 2016 (undefined)
Primary Completion Date
December 8, 2017 (Actual)
Study Completion Date
December 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to examine the effects of 1-week of overeating on important clinical metabolic health outcomes (e.g., glucose tolerance, blood lipid profile, and blood pressure) and factors regulating the structure and metabolic function of fat tissue. This study will determine how regular exercise during this overeating period impacts these responses.
Detailed Description
If subjects are eligible and decide to participate, they will take part in two identical study trials. One is scheduled before and the other is scheduled after 1 week of overeating controlled by the study team. Subjects who exercise regularly will be instructed to exercise the day before their first study trial - and they will be required to exercise during 6 of the 7 days of the overeating period (including the day before their second study trial). Subjects who do not regularly exercise (no planned physical activity) will remain inactive until the completion of both study trials. Before each study trial If a subject is a regular exerciser, they will be asked to come to the Substrate Metabolism Laboratory in the afternoon before each of the 2 study trials to exercise in the lab for 45 min at a moderate intensity. The evening before the study trial, all subjects will need to eat a standardized dinner meal and snack. They must eat the meal and snack at specific times as indicated by the research staff. After eating the snack, subjects will need to fast (no food or beverages - besides water) overnight. During each study trial Subjects will arrive at the Substrate Metabolism Laboratory at 7:00AM and will rest quietly for approximately 30 min. After which, the study team will measure their resting blood pressure and their resting metabolic rate. An intravenous catheter (IV) will then be placed in a vein of the subject's hand or forearm for blood sampling. The research team will then collect a small sample of fat tissue in the subject's abdomen with a needle. Next, subjects will drink a sweet sugar solution for an Oral Glucose Tolerance Test (OGTT) and the research team will collect blood samples every 15 min for 3 hours. After this 3 hour test, the IV catheter will be removed and subjects will be provided breakfast and discharged.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Overeating Protocol
Arm Type
Experimental
Arm Description
Subjects will ingest 30% more calories per day than their calculated daily energy requirements (~750kcals extra energy intake each day). All subjects will be instructed (and will be guided) to consume a diet containing approximately 50% carbohydrate, 35% fat, and 15% protein.
Intervention Type
Dietary Supplement
Intervention Name(s)
Overeating Protocol
Intervention Description
Subjects will ingest 30% more calories per day than their calculated daily energy requirements (~750kcals extra energy intake each day). All subjects will be instructed (and will be guided) to consume a diet containing approximately 50% carbohydrate, 35% fat, and 15% protein.
Primary Outcome Measure Information:
Title
Oral Glucose Tolerance
Description
An index of insulin sensitivity will be measured using the plasma insulin and glucose concentrations during the 3h OGTT
Time Frame
up to 1 week
Secondary Outcome Measure Information:
Title
Resting Metabolic Rate
Time Frame
baseline and 1 week
Title
Total Cholesterol
Description
Plasma concentrations of total- cholesterol will be measured
Time Frame
baseline and 1 week
Title
PPARg mRNA expression
Description
cytokine proteins will be measured in adipose tissue
Time Frame
baseline and 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 18-40 Body Mass Index: 20-30 kg/m2 Exercise group: (≥5 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities) No Exercise group: no regularly planned exercise/physical activity Women must have regularly occurring menses and must be premenopausal Exclusion Criteria: Pregnant or lactating Blood pressure > 140/90 mm Hg Evidence/history of cardiovascular or metabolic disease Medications known to affect lipid or glucose metabolism Tobacco or electronic cigarette user
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey F Horowitz
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35816737
Citation
Ludzki AC, Krueger EM, Gillen JB, Taylor NM, Middlebrook DO, Baldwin TC, Karabetsos KC, Schleh MW, Horowitz JF. One week of overeating upregulates angiogenic and lipolytic gene expression in human subcutaneous adipose tissue from exercise trained and untrained adults. Appl Physiol Nutr Metab. 2022 Oct 1;47(10):992-1004. doi: 10.1139/apnm-2022-0078. Epub 2022 Jul 11.
Results Reference
derived

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Impact of Exercise on the Metabolic Consequences of Overeating

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