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: December 13, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 14, 2010
Last Updated Date	December 13, 2012
Start Date ^ICMJE	March 2010
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 3, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01115075 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 3, 2010)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Oscillations of Dietary Fat/Carbohydrate Intake Over Interval of 3 to 4 Days
Official Title ^ICMJE	Oscillations in Dietary Fat Intake and Leptin Changes Among People Who Record Dietary Intake Accurately: the Dietitian Study II
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Healthy
Intervention ^ICMJE	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.
Study Arm (s)	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. Interventions: Other: Dietary fat/intake of carbohydrate Behavioral: Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	June 2013
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	21 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01115075
Other Study ID Numbers ^ICMJE	Dietitian II
Has Data Monitoring Committee	No
Responsible Party	George A. Bray, Pennington Biomedical Research Center
Study Sponsor ^ICMJE	Pennington Biomedical Research Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Pennington Biomedical Research Center
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top