NCT00830999

Brief Summary

This study is being conducted to learn more about the role of diet and exercise in regulating plasma triglyceride (fat) metabolism. The investigators will examine the effect of acute (24 hour) changes in energy intake and expenditure on fat metabolism the following day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable cardiovascular-diseases

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

April 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

6.7 years

First QC Date

January 26, 2009

Last Update Submit

January 18, 2013

Conditions

Keywords

fat metabolismexerciseliverlipoproteinstriglycerides

Outcome Measures

Primary Outcomes (1)

  • Very Low Density Lipoprotein-Triglyceride and apoB-100 concentrations

    After acute (24 hour) changes in energy intake and/or energy expenditure

Secondary Outcomes (8)

  • Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 secretion rates

    After acute (24 hour) changes in energy intake and/or energy expenditure

  • Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 clearance rates from plasma

    After acute (24 hour) changes in energy intake and/or energy expenditure

  • Plasma glucose concentration and turnover rate

    After acute (24 hour) changes in energy intake and/or energy expenditure

  • Plasma insulin concentration

    After acute (24 hour) changes in energy intake and/or energy expenditure

  • Plasma free fatty acid concentration and turnover rate

    After acute (24 hour) changes in energy intake and/or energy expenditure

  • +3 more secondary outcomes

Study Arms (4)

Positive energy balance

EXPERIMENTAL

Comparison between isocaloric and hypercaloric diets with no exercise performed in any trials

Behavioral: Positive energy balanceBehavioral: Energy balance

Energy balance with exercise

EXPERIMENTAL

Comparison between an isocaloric diet without exercise and a hypercaloric diet with a sufficient amount of exercise performed to match the excess calories consumed resulting in both trials being in net energy balance.

Behavioral: Energy balance with exerciseBehavioral: Energy balance

Negative energy balance

EXPERIMENTAL

Comparison between isocaloric and hypocaloric diets with no exercise performed in any trials

Behavioral: Negative energy balanceBehavioral: Energy balance

Negative energy balance with exercise

EXPERIMENTAL

Comparison between consuming an isocaloric diet without exercise and consuming the same amount of calories as in the isocaloric trial but with exercise performed resulting in net negative energy balance in the exercise trial.

Behavioral: Negative energy balance with exerciseBehavioral: Energy balance

Interventions

Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.

Positive energy balance

Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands but will perform 2 hours of exercise that will be sufficient to burn off the excess calories consumed resulting in subjects being in net energy balance.

Energy balance with exercise

Subjects will consume over a 24 h period only 66% of the calories required to meet their energy demands such that they will be in a net negative calorie balance in this trial.

Negative energy balance

Subjects will consume over a 24 hour period the same amount of calories as ingested in the isocaloric trial but will also perform 2 hours of exercise that will be sufficient to burn off a third of the calories they consumed during this day resulting in subjects being in net negative energy balance in this trial

Negative energy balance with exercise
Energy balanceBEHAVIORAL

Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.

Energy balance with exerciseNegative energy balanceNegative energy balance with exercisePositive energy balance

Eligibility Criteria

Age21 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • overweight and obese men
  • normal to mild hypertriglyceridemia

You may not qualify if:

  • Smoking
  • Any medical condition other than increased body weight (e.g. diabetes, heart disease, etc.).
  • Use of drugs known to affect lipid metabolism (e.g. statins, etc.).
  • Regular exercise training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Smith GI, Magkos F, Reeds DN, Okunade AL, Patterson BW, Mittendorfer B. One day of mixed meal overfeeding reduces hepatic insulin sensitivity and increases VLDL particle but not VLDL-triglyceride secretion in overweight and obese men. J Clin Endocrinol Metab. 2013 Aug;98(8):3454-62. doi: 10.1210/jc.2013-1786. Epub 2013 Jun 7.

MeSH Terms

Conditions

Cardiovascular DiseasesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bettina Mittendorfer, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 28, 2009

Study Start

April 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations