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Completed

NCT Number: NCT00123214

A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation

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.

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Key information

Conditions

Sleep Deprivation Body Weight Body Weight Changes Cognition Disorders Cognitive Dysfunction Dyslipidemias Dyssomnias Hyperlipidemias Inflammation Lipid Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders Weight Gain

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Vincent's Hospital

New York, 10011, United States

About this study

This pilot study included 18 medical residents at two academic medical centers in New York City. All residents who participated in the study were assigned to work a night shift schedule for two weeks, and began the study on the morning prior to their first evening shift. The study subjects were randomly assigned to one of two groups:

  • Intervention diet -- consisting of 40% carbohydrates, 30% protein, and 30% fat with 2.4g of long chain fatty acid supplements (n=9) Total calories for males was 1600/day, and 1200/day for females
  • Control group -- ad lib diet.

Main outcome measures included:

  • weight
  • resting metabolic rate
  • percent body fat
  • lipid profile
  • CRP
  • fasting glucose and insulin levels
  • urinary neurotransmitter levels
  • salivary cortisol
  • six cognitive tests of memory, attention, and executive function.

Subjects were tested on day 1, 7, and 14 of the study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Controlled Dietary Intervention

Drug

Primary outcomes

  1. Resting Metabolic Rate

Secondary outcomes

  1. Weight

  2. Percent Body Fat

  3. Waist Circumference

  4. Lipid Profile

  5. C-reactive Protein Levels

  6. Fasting serum glucose

  7. Fasting serum insulin

  8. Urinary neurotransmitter levels

  9. Salivary a.m. cortisol levels

  10. Cognitive scores on: Stroop Test, Hopkins Verbal Learning Test, Trail Making Test, Digit Span, Block Design, Dynamic Visual Acuity, Short Form 36

Sponsors and collaborators

Lead sponsor

St. Vincent's Medical Center

Unknown

Collaborators

  • Inflammation Research Foundation, Marblehead, MA.
  • NeuroScience, Inc., Osceola, WI.

Registry information

Official study title

Pilot Study: A Dietary Intervention May Decrease the Negative Metabolic and Cognitive Consequences of Chronic Sleep Deprivation

Important dates

Study start
2004
Study completion
2005
First posted
Jul 22, 2005
Registry last updated
Jun 27, 2006

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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