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

Study Overview
=================
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.

Official Title
-----------------
Oscillations in Dietary Fat Intake and Leptin Changes Among People Who Record Dietary Intake Accurately: the Dietitian Study II

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Dietary fat/intake of carbohydrate
* Behavioral: Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietitian<br>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<br>* Spontaneous intake of fat, carbohydrate, protein and alcohol each day for 17 days.<br>* Other names: Dietitian II;Behavioral: Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanisms for oscillations of dietary fat/carbohydrate intake | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leptin, Changes in leptin may precede the, phasing of oscillations of dietary fat intake