NCT00611117

Brief Summary

The study is designed to determine the effect of high physical activity level vs. low physical activity level on the adaptation to a high fat diet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2007

Longer than P75 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

May 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
11.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 21, 2022

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

January 28, 2008

Last Update Submit

September 16, 2022

Conditions

Keywords

adaptation to high fat dietactivityexercise

Outcome Measures

Primary Outcomes (1)

  • To determine the effects of a high fat diet [at both low and high physical activity] on • Sk muscle PGC1α and PDK4 mRNA and protein • Glucose oxidation • Fatty acid oxidation • Hepatic and skeletal muscle lipid • VO2 max • Mitochondr

    One Year

Study Arms (2)

1

EXPERIMENTAL

High intensity exercise and high fat diet

Other: Physical Activity Level

2

EXPERIMENTAL

Low intensity exercise and high fat diet

Other: Physical Activity Level

Interventions

High vs. low physical activity during a high fat diet consumption.

12

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders and all races will be invited to participate
  • BMI \> 19 and \< 35 kg/m2
  • Age 18-35
  • Women will be asked to participate in the follicular phase of the menstrual cycle as determined by menstrual history and a negative pregnancy test will be recorded prior to participation
  • Willing and able to walk on a treadmill at a pace of 3 mph at 3%grade for 3-4 hours/day for 3 consecutive days
  • Willing to eat only and all foods provided by Pennington for 9 days on 2 occasions (18 days)
  • Willing to stop alcohol consumption for the duration of the study
  • Able come to Pennington for meals and tests for 20 days 12 of these inpatient.

You may not qualify if:

  • Significant renal, hepatic, endocrine, pulmonary, cardiac or hematological disease (for the consent form you will have to use kidney, liver, etc )
  • You abuse alcohol or illegal drugs or are unable to avoid alcohol or caffeine prior to testing
  • Smokers
  • Unable or unlikely to eat all and only food provided by the PBRC metabolic kitchen.
  • Pregnant or planning to become pregnant
  • Corticosteroid use in previous two months
  • Chronic use of anti-diabetic, anti-hypertensive, or other medications known to affect fat metabolism
  • Use of Depo-Provera, hormone implants or estrogen replacement therapy
  • Irregular menstrual cycles
  • Post-menopausal women
  • Weight gain or loss of \> 3kg in the last 6 months
  • Unable or unwilling to perform treadmill walking at the required speed and incline to achieve 1.8\*RMR
  • History or family history of blood clots deep vein thrombosis or pulmonary embolism)
  • Poor circulation, bypass operation on legs, blood coagulation disorders, diagnosed peripheral arterial or vascular disease, cramping pain in your muscle during exercise or nerve damage in your legs.
  • You had major surgery on the abdomen, pelvis or legs within previous 3 months.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Steven Smith

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR
  • George Bray

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 8, 2008

Study Start

May 1, 2007

Primary Completion

March 1, 2009

Study Completion

June 1, 2020

Last Updated

September 21, 2022

Record last verified: 2016-01

Locations