NCT01115075

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

April 14, 2010

Last Update Submit

January 22, 2016

Conditions

Keywords

LeptinChanges in leptin may precede thephasing of oscillations of dietary fat intake

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

EXPERIMENTAL

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

Interventions

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

Also known as: Dietitian II
Dietitian

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.

Dietitian

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Interventions

Nutritionists

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

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

Locations