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NCT01866280 · ClinicalTrials.gov registry record · NA

Sleep Timing and Energy Balance

A NA study, sponsored by St. Luke's-Roosevelt Hospital Center.

Completed
Registry status
NA
Development phase
5
Enrollment target

NCT01866280: Completed NA study, sponsored by St. Luke's-Roosevelt Hospital Center.

NCT01866280 is a NA study that has completed, run by St. Luke's-Roosevelt Hospital Center. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01866280, a NA study, has completed, sponsored by St. Luke's-Roosevelt Hospital Center.

COMPLETED
Registry status
NA
Development phase
5 participants
Enrollment target

Study Summary

The purpose of this study is to test the effects of sleep and meal timing, independent of sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in normal weight adults. This study will be a 4-phase, randomized controlled study of 5 days each in which participants will undergo 2 phases of late sleep times that differ in meal timing (normal or late) and 2 phases of normal sleep times that differ in meal timing (normal or late). The Aims and Hypotheses of this study are: Aim 1: To compare hormonal regulation of food intake and metabolic risk markers in response to altered sleep and meal timing. * Hypothesis 1: There will be an interaction between sleep and meal time on glucose, insulin, and glucose and insulin area under the curve after the glucose tolerance test such that the late sleep/late meal will result in the worst metabolic profile, normal sleep/late meal and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal will result in the best metabolic profile. * Hypothesis 2: There will be an interaction between sleep and meal time on leptin and ghrelin concentrations such that the late sleep/late meal timing phase will result in low leptin/high ghrelin, normal sleep/late meal timing and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal timing will result in high leptin/low ghrelin. Aim 2: To compare food intake over a 24-h period in response to altered sleep and meal timing. • Hypothesis 3: Energy and fat intakes will be greater during the late sleep timing phase compared to normal sleep timing.

Primary Outcome

Ad libitum food intake will be assessed on day 5

Interventions

  • BEHAVIORAL Normal sleep
  • BEHAVIORAL Normal meals
  • BEHAVIORAL Late sleep
  • BEHAVIORAL Late meals

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2012-11
Est. Completion 2013-09
Phase NA

What the finished NCT01866280 record still lists

NCT01866280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 4 interventions - of which Normal sleep is the first listed.

NCT01866280 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01866280 about?

NCT01866280 is a clinical study titled "Sleep Timing and Energy Balance". The purpose of this study is to test the effects of sleep and meal timing, independent of sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in normal weight adults. This study will be a 4-phase, randomized controlled study of 5 days each in which participant...

What is the current status of trial NCT01866280?

This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2012-11. Estimated completion is 2013-09.

What interventions are being tested in trial NCT01866280?

The interventions under investigation include: Normal sleep (BEHAVIORAL), Normal meals (BEHAVIORAL), Late sleep (BEHAVIORAL), Late meals (BEHAVIORAL).

Who is sponsoring clinical trial NCT01866280?

This trial is sponsored by St. Luke's-Roosevelt Hospital Center, which has 57 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01866280's enrollment target sits among peer trials

5 1988th of 2000 higher than 5 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01866280, the US trial registry maintained by the National Library of Medicine. NCT01866280 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.