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

NCT ID: NCT01115075

Last Updated: 2016-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dietary fat/intake of carbohydrate

Intervention Type OTHER

Spontaneous intake of fat, carbohydrate, protein and alcohol each day for 17 days.

Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.

Intervention Type BEHAVIORAL

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.

Interventions

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Dietary fat/intake of carbohydrate

Spontaneous intake of fat, carbohydrate, protein and alcohol each day for 17 days.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Dietitian II

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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George A. Bray

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 29017

Identifier Type: -

Identifier Source: org_study_id

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