Oscillations of Dietary Fat/Carbohydrate Intake Over Interval of 3 to 4 Days

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
George A. Bray, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01115075
First received: April 14, 2010
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to understand the mechanisms for oscillations of dietary fat/carbohydrate intake and how fat intake affect insulin resistance and liver fat over interval of 3 to 4 days.


Condition Intervention
Healthy
Other: Dietary fat/intake of carbohydrate
Behavioral: Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oscillations in Dietary Fat Intake and Leptin Changes Among People Who Record Dietary Intake Accurately: the Dietitian Study II

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Mechanisms for oscillations of dietary fat/carbohydrate intake [ Time Frame: 17 consecutive days (11 visits on site) ] [ Designated as safety issue: No ]
    Test the spontaneous intake of fat, carbohydrate,protein and alcohol each day for 17 consecutive days. Examine spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.


Secondary Outcome Measures:
  • Energy Intake [ Time Frame: 17 days ] [ Designated as safety issue: No ]
    During the same time interval, integrated energy expenditure will be recoreded using doubly-labeled water and day to day energy expenditure by accelerometer.


Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: June 2020
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietitian
Recruitment of dietitians and senior level or graduate level dietetics students who are not restrained eaters. This group is skilled in identifying and accurately recording food than individuals not trained in dietetics.
Other: Dietary fat/intake of carbohydrate
Spontaneous intake of fat, carbohydrate, protein and alcohol each day for 17 days.
Other Name: Dietitian II
Behavioral: Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.
Dietitians and senior level or graduate level dietetics students who are not restrained eaters to participate in food intake over 17 days. During this same time interval, integrated energy expenditure will be recorded using doubly-labeled water and day to day energy expenditure by accelerometer. Periodic blood sampling for leptin will be done completed at site intervals.

Detailed Description:

You will be expected to keep diet records for 17 consecutive days. You will start with a fasting screening visit (only water allowed). A physical exam and Medical history it taken at screening visit. Your body composition will be gathered by CT and Dexa Scan. Blood and urine will be collected for a chemical profile and other determinations. Questionnaires will be administered along with an accelerometer to be worn for the remainder of the study. The final day you will return the dietary records, accelerometer, and a few procedures will be performed as weight.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • You are a dietitian or a senior level or graduate level dietetics student
  • You are between the ages of 21-55 years inclusive and a nonsmoker
  • you are not a restrictive diet or strenuous exercise regimen
  • You typically eat several meals per day

Exclusion Criteria:

  • You have an eating disorder or history
  • You abuse alcohol or other substances, and consume no more than 3 alcoholic drinks per day
  • You have no current regular use of some over-the-counter medication or prescription medication, excluding headache medicines, blood pressure medications, etc.
  • You have gained/lost more than 10 pounds of body weight in the last year
  • You have recently had or anticipating significant life changes during the course of your participation in the study.
  • You have an eating disorder or history
  • You have a major psychiatric illness or history
  • You have no serious current clinical disease or surgical condition that may interfere with the study.
  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: NCT01115075

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: George A. Bray, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01115075     History of Changes
Other Study ID Numbers: Dietitian II
Study First Received: April 14, 2010
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Leptin
Changes in leptin may precede the
phasing of oscillations of dietary fat intake

ClinicalTrials.gov processed this record on July 20, 2014