NCT02291952

Brief Summary

The goal of this application is to determine whether changing the timing of food intake prevents the adverse metabolic effects of circadian misalignment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 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

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

March 19, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2018

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

3.4 years

First QC Date

November 12, 2014

Last Update Submit

March 18, 2020

Conditions

Circadian Dysregulation

Keywords

Circadian Misalignment, Forced Desynchrony, Metabolism, Meal-timing, Circadian

Outcome Measures

Primary Outcomes (6)

  • Change in plasma leptin levels across sleep/wake cycle

    Frequent blood samples

    During circadian alignment (Day 7) and circadian misalignment (Day 10-11)

  • Change in circadian profile of plasma leptin

    Frequent blood samples

    During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)

  • Change in glucose tolerance

    Frequent blood samples before and after standardized meals

    During circadian alignment (Day 7) and circadian misalignment (Day 10-11)

  • Change in circadian profile of plasma glucose levels

    Frequent blood samples

    During circadian alignment (Day 7) and circadian misalignment (Day 10-11)

  • Change in plasma insulin levels after standardized test meal

    Frequent blood samples before and after standardized meals

    During circadian alignment (Day 7) and circadian misalignment (Day 10-11)

  • Change in circadian profile of plasma insulin levels

    Frequent blood samples

    During circadian alignment (Day 7) and circadian misalignment (Day 10-11)

Secondary Outcomes (5)

  • o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol

    Core temperature and frequent blood samples

  • Changes circadian rhythm in resting energy expenditure

    During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)

  • Change in hunger and appetite, mood, and cognitive performance

    Tests taken throughout the protocol, days 1-14

  • Changes in microbiota, gene expression, epigenetic or proteomic markers

    samples taken during forced desychrony (days 7-11) and the constant routine protocols (days 3-4 and 11-13)

  • Changes in sleep

    sleep periods following day 1, days 6-7 and days 10-11

Study Arms (2)

Experimental

EXPERIMENTAL

During Forced Desynchrony sleep and wake will occur at different circadian phases, while meals are restricted to the biological day.

Behavioral: Meal schedule

Control

OTHER

During Forced Desynchrony sleep and wake, as well as meals, will occur at different circadian phases.

Behavioral: Meal schedule

Interventions

Meal scheduleBEHAVIORAL
ControlExperimental

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18.5 and 29.9 kgm-2
  • Healthy adults with regular sleep-wake timing
  • Non-smokers
  • Completion of medical and psychological screening tests
  • Able to spend 14 consecutive days in the sleep laboratory

You may not qualify if:

  • BMI \<18.5 or \> 29.9 kgm-2
  • History of neurological or psychiatric disorder
  • History of sleep disorder or regular use of sleep-promoting medication
  • Current prescription, herbal, or over-the-counter medication use
  • Traveling across 2 or more time zones within past 3 months
  • Donating blood within past 8 weeks
  • Worked night or rotating shift work within past 3 years
  • Hearing impairment
  • Drug or alcohol dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Chellappa SL, Engen PA, Naqib A, Qian J, Vujovic N, Rahman N, Green SJ, Garaulet M, Keshavarzian A, Scheer FAJL. Proof-of-principle demonstration of endogenous circadian system and circadian misalignment effects on human oral microbiota. FASEB J. 2022 Jan;36(1):e22043. doi: 10.1096/fj.202101153R.

    PMID: 34861073DERIVED

MeSH Terms

Conditions

Chronobiology Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Frank A Scheer, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Frank AJL Scheer, PhD

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

March 19, 2015

Primary Completion

August 29, 2018

Study Completion

August 29, 2018

Last Updated

March 19, 2020

Record last verified: 2020-03

Locations

US(1)