Role of Photic and Non-photic Time Cues in Resetting Circadian Rhythms

NCT05276739 | Unknown

• 1 other identifier: 2021P000757
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the principal time cue (light or meals) for resetting circadian rhythms in melatonin and metabolic outcomes.

Conditions

Light Exposure; Meal Timing

Outcome Measures

Primary Outcomes (3)

• Amplitude of Phase Response Curve of melatonin

  Amplitude of phase response curve of melatonin derived by fitting a sinusoidal regression to the individual phase shift data across \~24 hours

  24 hours

• Amplitude of Phase Response Curve of triglyceride

  Amplitude of phase response curve of triglyceride derived by fitting a sinusoidal regression to the individual phase shift data across \~24 hours

  24 hours

• Amplitude of Phase Response Curve of cholesterol

  Amplitude of phase response curve of cholesterol derived by fitting a sinusoidal regression to the individual phase shift data across \~24 hours

  24 hours

Secondary Outcomes (3)

• Area under the curve (AUC) of melatonin

  6.5 hours during intervention

• Area under the curve (AUC) of triglyceride

  6.5 hours during intervention

• Area under the curve (AUC) of cholesterol

  6.5 hours during intervention

Study Arms (3)

Bright light

EXPERIMENTAL

Participants will receive a 6.5-hour 10,000 lux light pulse (4100K fluorescent light) centered within the 16-hour wake episode (start 4.75 hour after wake and end 11.25 hour after wake). Participants will receive 4 identical meals (equal calories and macronutrient content), over a 12-hour interval (meals at 2, 6, 10, and 14 hours after waking) centered within the 16-hour wake episode.

Behavioral: Bright Light; Behavioral: 12-h meal window

Time-restricted eating

EXPERIMENTAL

Participants will consume 4 identical meals, as in the other groups, except that the meal window will be restricted to 6.5 hours instead of 12 hours (meals at 4.75, 6.9, 9.1, 11.25 hours after waking) centered within the 16-hour wake episode. Participants will remain in dim light (\<3 lux) throughout the 16-hour wake episode.

Behavioral: Time-restricted eating; Behavioral: Dim light

Control

SHAM COMPARATOR

Participants will receive 4 identical meals (equal calories and macronutrient content), over a 12-hour interval (meals at 2, 6, 10, and 14 hours after waking) centered within the 16-hour wake episode. Participants will remain in dim light (\<3 lux) throughout the 16-hour wake episode.

Behavioral: Dim light; Behavioral: 12-h meal window

Interventions

Bright Light BEHAVIORAL

6.5-hour 10,000 lux light pulse (4100K fluorescent light) centered within the 16-hour wake episode (start 4.75 hour after wake and end 11.25 hour after wake).

Bright light

Time-restricted eating BEHAVIORAL

6.5-hour restricted meal window (4 meals at 4.75, 6.9, 9.1, 11.25 hours after waking) centered within the 16-hour wake episode.

Time-restricted eating

Dim light BEHAVIORAL

dim light (\<3 lux) throughout the 16-hour wake episode

Control; Time-restricted eating

12-h meal window BEHAVIORAL

12-hour restricted meal window (4 meals at 2, 6, 10, and 14 hours after waking) centered within the 16-hour wake episode.

Bright light; Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18-30 years
• Healthy (no medical, psychiatric or sleep disorders;
• Non-smoking for at least 6 months;
• Body Mass Index of \>18 or \<30 kg/m2;
• Able to maintain 8-hour consistent sleep schedule during the study
• Able to refrain from caffeine, alcohol, medication and supplements during the study

You may not qualify if:

• History of alcohol or substance abuse;
• Positive result on drugs of abuse urine toxicology;
• Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, narcolepsy, insomnia, or any significant sleep complaint
• Psychiatric disorder, or first degree relative with a psychiatric disorder
• Recent acute or chronic medical disorder
• Use of drugs or medication (birth control OK) likely to affect sleep, alertness or light sensitivity, as determined by the investigators
• Visual disorder, including but not limited to color blindness, or family history of glaucoma
• Pregnancy or lactation
• Shift work (past 3 years)
• Transmeridian travel (2 or more time zones) in the past 3 months
• Any other reason as determine by the Principal Investigator

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Central Study Contacts

Shadab A Rahman, PhD, MPH

CONTACT

6175258830; sarahman@rics.bwh.harvard.edu

Leilah K Grant, PhD

CONTACT

6175257118; lgrant@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 3 condition, parallel arm randomized control trial

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 11, 2022
• Study Start: July 29, 2022
• Primary Completion: March 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)