NCT00123214

Brief Summary

The purpose of this study is to determine whether or not a low calorie, low glycemic index diet with omega-3 fatty acid supplements can prevent some of the negative consequences of sleep deprivation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
Last Updated

June 27, 2006

Status Verified

July 1, 2005

First QC Date

July 19, 2005

Last Update Submit

June 26, 2006

Conditions

Sleep Deprivation

Keywords

DietChronic sleep deprivationWeightCognitive impairmentLipidsInflammationResting metabolic rateWeight GainPercent Body FatHyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Resting Metabolic Rate

Secondary Outcomes (10)

  • Weight

  • Percent Body Fat

  • Waist Circumference

  • Lipid Profile

  • C-reactive Protein Levels

  • +5 more secondary outcomes

Interventions

Controlled Dietary InterventionDRUG

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medical resident in good standing at Cabrini Medical Center or Saint Vincent's Hospital, NY.
  • Must be scheduled for two consecutive weeks of night shift work.

You may not qualify if:

  • Febrile illness
  • Smoker
  • Food allergies of any kind
  • Taking any prescription medication
  • History of diabetes or thyroid dysfunction
  • Body mass index (BMI)\>30
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Vincent's Hospital

New York, New York, 10011, United States

Location

Related Links

MeSH Terms

Conditions

Sleep DeprivationBody WeightCognitive DysfunctionInflammationWeight GainHyperlipidemias

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersCognition DisordersNeurocognitive DisordersPathologic ProcessesBody Weight ChangesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Valerie A Jones, MD

    Saint Vincent's Hospital, Manhattan

    PRINCIPAL INVESTIGATOR

  • Steven M Lascher, DVM

    Saint Vincent's Hospital, Manhattan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
UNKNOWN

Study Record Dates

First Submitted

July 19, 2005

First Posted

July 22, 2005

Study Start

September 1, 2004

Study Completion

April 1, 2005

Last Updated

June 27, 2006

Record last verified: 2005-07

Locations

US(1)