Oscillations of Dietary Fat/Carbohydrate Intake Over Interval of 3 to 4 Days
Dietitian II
Oscillations in Dietary Fat Intake and Leptin Changes Among People Who Record Dietary Intake Accurately: the Dietitian Study II
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Mar 2010
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 14, 2010
CompletedFirst Posted
Study publicly available on registry
May 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJanuary 25, 2016
January 1, 2016
1 year
April 14, 2010
January 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Energy Intake
17 days
Study Arms (1)
Dietitian
EXPERIMENTALRecruitment 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.
Interventions
Spontaneous intake of fat, carbohydrate, protein and alcohol each day for 17 days.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 14, 2010
First Posted
May 4, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2011
Study Completion
June 1, 2014
Last Updated
January 25, 2016
Record last verified: 2016-01