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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Dietary fat/intake of carbohydrate; Behavioral: Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.

• Registration Number: NCT01115075
• Lead Sponsor: Pennington Biomedical Research Center

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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Primary Completion: 2011-03
• Study Completion: 2014-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dietitian	Dietary fat/intake of carbohydrate	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.
Dietitian	Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.	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.

Primary Outcome Measures

Name	Time	Method
Mechanisms for oscillations of dietary fat/carbohydrate intake	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.

Secondary Outcome Measures

Name	Time	Method
Energy Intake	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.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States