NCT00943436

Brief Summary

The purpose of this study is to determine whether or not energy and macronutrient intake changes when comparing habitually active and habitually sedentary college-aged males in two different sessions of one resting and one exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

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

November 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

July 13, 2011

Completed
Last Updated

June 29, 2018

Status Verified

April 1, 2018

Enrollment Period

9 months

First QC Date

July 20, 2009

Results QC Date

July 2, 2010

Last Update Submit

April 3, 2018

Conditions

Active Lifestyle MalesInactive Lifestyle Males

Keywords

ExerciseSedentaryEnergy ExpenditureEnergy BalanceMacronutrient IntakeEnergy and Macronutrient intakeExercise and Energy Balance

Outcome Measures

Primary Outcomes (8)

  • Energy Intake at the Meal (Exercise Session)

    Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.

    2 hours

  • Energy Intake at the Meal (Rest Session)

    Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.

    2 hours

  • Percent Energy From Carbohydrate at the Meal (Exercise Session)

    Carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.

    2 hours

  • Percent Energy From Carbohydrate at the Meal (Rest Session)

    carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.

    2 hours

  • Percent Energy From Protein at the Meal (Exercise Session)

    Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.

    2 hours

  • Percent Energy From Protein at the Meal (Rest Session)

    Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.

    2 hours

  • Percent Energy From Fat at the Meal (Exercise Session)

    Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.

    2 hours

  • Percent Energy From Fat at the Meal (Rest Session)

    Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.

    2 hours

Study Arms (2)

Active males

ACTIVE COMPARATOR

Males who participate in at least 30 minutes of physical activity on 5 or more days per week for the last month.

Other: Exercise SessionOther: Rest Session

Inactive males

ACTIVE COMPARATOR

Males who participate in less than 1 hour of physical activity per week for the last month.

Other: Exercise SessionOther: Rest Session

Interventions

Exercise SessionOTHER

This study consists of two laboratory sessions. Participants will be randomly assigned to the order in which they go through these two sessions. The "Exercise Session" will consist of the participant coming into the lab and completing 45 min bout of exercise on an exercise bike, followed by a 60 min resting period, followed by the lunch buffet portion of the session where they will have 25 min to eat ad libitum.

Active malesInactive males
Rest SessionOTHER

This study consists of two laboratory sessions. Participants will be randomly assigned to the order in which they go through these two sessions. The "Rest Session" will consist of the participant coming into the lab and completing a 45 min period of reading followed by a 60 min resting period, followed by the lunch buffet portion of the session where they will have 25 min to eat ad libitum.

Active malesInactive males

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI of 20-25
  • Percent body fat of 10-18%
  • Exercises greater than or equal to 5 days/wk at 30 min/day or less than or equal to 1 day/week at 1 hour/day consistently for the past month
  • Likes study foods

You may not qualify if:

  • Does not fit in exercise criteria
  • Allergies or unwillingness eat study food, falls
  • From survey qualifies as a "conscious eater"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Laboratory, University of Tennessee

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Emily Jokisch
Organization
Healthy Eating and Activity Laboratory- University of Tenneessee
ejokisch@utk.edu
865-974-0754

Study Officials

  • Hollie Raynor, PhD, RD

    University of Tennessee, Knoxville

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 22, 2009

Study Start

November 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

June 29, 2018

Results First Posted

July 13, 2011

Record last verified: 2018-04

Locations

US(1)