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Completed

NCT Number: NCT01115075

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

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.

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Key information

Conditions

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary fat/intake of carbohydrate

Other

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

Other names: Dietitian II

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Acronym: Dietitian II

Important dates

Study start
2010
Primary completion
2011
Study completion
2014
First posted
May 4, 2010
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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