Oscillations of Dietary Fat/Carbohydrate Intake Over Interval of 3 to 4 Days (Dietitian II)

January 22, 2016 updated by: George A. Bray, Pennington Biomedical Research Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanisms for oscillations of dietary fat/carbohydrate intake
Time Frame: 17 consecutive days (11 visits on site)
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.
17 consecutive days (11 visits on site)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy Intake
Time Frame: 17 days
During the same time interval, integrated energy expenditure will be recoreded using doubly-labeled water and day to day energy expenditure by accelerometer.
17 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

January 25, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PBRC 29017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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