Mechanisms of the Effect of Physical Activity on the Adaptation to a High-Fat Diet

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
George A. Bray, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00611117
First received: January 28, 2008
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Healthy
Other: Physical Activity Level

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Basic Science
Official Title: Mechanisms of the Effect of Physical Activity on the Adaptation to a High-Fat Diet

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • 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 [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2007
Estimated Study Completion Date: June 2020
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
High intensity exercise and high fat diet
Other: Physical Activity Level
High vs. low physical activity during a high fat diet consumption.
Experimental: 2
Low intensity exercise and high fat diet
Other: Physical Activity Level
High vs. low physical activity during a high fat diet consumption.

Detailed Description:

A high fat diet is linked to weight gain and obesity. An adjustment to the acute exposure to high fat diet is not abrupt and takes time. In a previous study from our laboratory, it has been shown that high level of physical activity can accelerate the adaptation to a high fat diet by increasing fat oxidation. In this study we will determine the mechanism involved in this adjustment. Our hypotheses are:

  1. High fat diets decrease skeletal muscle glucose metabolism and decrease mitochondrial biogenesis through the upregulation of PDK4 and downregulation of PGC1α; increased physical activity will prevent these deleterious effects.
  2. A high fat diet will increase hepatic and skeletal muscle lipid; increased physical activity will prevent these deleterious effects.
  3. These effects are more pronounced in individuals with a low mitochondrial content
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • You have cancer
  • You have rheumatoid disease/ walking or joint problems
  • You are claustrophobic
  • You are depressed or have an eating disorder
  • You demonstrate a style of interpersonal relationships that would inhibit successful completion of the study

For the MRS / MRI, the following exclusion criteria apply:

  • Individuals who have a heart pacemaker, defibrillator, or non-removable hearing aid
  • Individuals with any clips or metal plates in their head
  • Individuals who have any artificial limbs or prosthetic devices
  • Individuals who were ever injured by a metallic foreign body which was not removed
  • Individuals with bridgework held in place by magnets
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611117

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
University of Washington
Investigators
Principal Investigator: Steven Smith Pennington Biomedical Research Center
Principal Investigator: George Bray Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: George A. Bray, Princiapal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00611117     History of Changes
Other Study ID Numbers: PBRC27017, 58-6535-5-071
Study First Received: January 28, 2008
Last Updated: January 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Pennington Biomedical Research Center:
adaptation to high fat diet
activity
exercise

ClinicalTrials.gov processed this record on July 29, 2014