NCT02701738

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable healthy

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

January 12, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2017

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

January 21, 2016

Last Update Submit

March 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oral Glucose Tolerance

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

    up to 1 week

Secondary Outcomes (3)

  • Resting Metabolic Rate

    baseline and 1 week

  • Total Cholesterol

    baseline and 1 week

  • PPARg mRNA expression

    baseline and 1 week

Study Arms (1)

Overeating Protocol

EXPERIMENTAL

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.

Dietary Supplement: Overeating Protocol

Interventions

Overeating ProtocolDIETARY_SUPPLEMENT

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.

Overeating Protocol

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Jeffrey F Horowitz

    University of Michigan

    PRINCIPAL INVESTIGATOR

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

January 21, 2016

First Posted

March 8, 2016

Study Start

January 12, 2016

Primary Completion

December 8, 2017

Study Completion

December 8, 2017

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations