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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

April 14, 2010
January 22, 2014
March 2010
March 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01115075 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Oscillations of Dietary Fat/Carbohydrate Intake Over Interval of 3 to 4 Days
Oscillations in Dietary Fat Intake and Leptin Changes Among People Who Record Dietary Intake Accurately: the Dietitian Study II

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.

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.

Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • 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.
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
June 2020
March 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01115075
Dietitian II
No
George A. Bray, Pennington Biomedical Research Center
Pennington Biomedical Research Center
Not Provided
Not Provided
Pennington Biomedical Research Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP