Recruiting

Nutrition Support

Sponsor:

Massachusetts General Hospital

Code:

NCT04737200

Conditions

Feeding Patterns

Sleep

Glucose Intolerance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Time-of-day of enteral nutrition provision (daytime first)

Time-of-day of enteral nutrition provision (nighttime first)

Study Details

Brief summary:

The purpose of this study is to determine whether modifying the timing of nutrition support from overnight to daytime enhances sleep quality, preserves circadian rhythms, and improves overall inflammation and cardiometabolic profiles in postoperative patients in the cardiac surgical ICU on enteral nutrition.

Conditions

Feeding Patterns

Sleep

Glucose Intolerance

Study ID

NCT04737200

Start date

Feb 8, 2022

Status verified date

May, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult male or non-pregnant female volunteers (age 18+)
  • Scheduled for a cardiac surgical procedure with planned post-operative admission to the ICU for >48 hours
  • Able and willing to give consent and comply with study procedures

Exclusion Criteria:

  • Blind, deaf or unable to speak English
  • Women who are pregnant or nursing
  • Contraindications to safe use enteral nutrition, including gastrointestinal obstruction
  • Personal history of intestinal malabsorption, gallbladder disease or pancreatitis
  • Dietary restrictions precluding enteral feeds
  • Renal and liver failure requiring dialysis or Child-Pugh score > 7
  • Severe deficit due to structural or anoxic brain damage
  • With skin condition that precludes wearing sensors

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Nighttime cycled enteral feeds first

Patients will start nighttime cycled enteral feeds first for 12 hours. Following a 24-hour washout period, patients will then start daytime cycled enteral feeds for 12 hours.

experimental: Daytime cycled enteral feeds first

Patients will start daytime cycled enteral feeds first for 12 hours. Following a 24-hour washout period, patients will then start nighttime cycled enteral feeds for 12 hours.

Interventions

Time-of-day of enteral nutrition provision (daytime first)

Enteral nutrition (tube feeds) will be provided during the daytime followed by nighttime.

Time-of-day of enteral nutrition provision (nighttime first)

Enteral nutrition (tube feeds) will be provided during the nighttime followed by daytime.

Primary outcome measure

  • Sleep fragmentation [ Time Frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds. ]
  • Circadian rhythms amplitude [ Time Frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds. ]

Central Contacts and Locations

Central contacts

Hassan S Dashti, Ph.D., R.D.

617-643-7167chrononutrition@mgh.harvard.edu

Richa Saxena, Ph.D.

rsaxena@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • Enteral Nutrition
  • Chrononutrition
  • Intensive Care Unit
  • Chronobiology
  • Nutrition Support
  • Sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-19.