Feeding PatternsNCT04737200
The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
A study testing Time-of-day of enteral nutrition provision (daytime first) and Time-of-day of enteral nutrition provision (nighttime first) in people with Feeding Patterns and Sleep, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Feeding Patterns, Sleep, Glucose Intolerance
- What is being tested?
- Time-of-day of enteral nutrition provision (daytime first) and Time-of-day of enteral nutrition provision (nighttime first)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Richa Saxena, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Hassan S Dashti
About this study
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.
Read the detailed description
Intensive care unit (ICU) environments do not support sleep or preserve circadian rhythms of postoperative critically ill patients. Among the contributing factors is the common practice of administering nutrition support through feeding tubes overnight. The overall objective of the study is to examine a novel dimension of clinical nutrition by determining whether enhancing sleep quality and preserving robust circadian rhythms through daytime instead of overnight feeds will attenuate inflammation and improve cardiometabolic profiles of postoperative cardiac ICU patients on nutrition support. The investigators hypothesize that overnight nutrition support results in fragmented sleep and blunted circadian rhythms and thus represent a modifiable mechanism exacerbating inflammation and cardiometabolic derangements in postoperative cardiac patients. Results of this study will help in the development of evidence-based, cost-efficient, and effective enteral nutrition timing countermeasures against fragmented sleep, disrupted circadian rhythms, inflammation and cardiometabolic derangements and potentially modify the current widespread practice of overnight nutrition likely affecting 250,000 hospital admissions annually in the United States.
- Conditions
- Feeding Patterns, Sleep, Glucose Intolerance
- Being tested
- Time-of-day of enteral nutrition provision (daytime first), Time-of-day of enteral nutrition provision (nighttime first)
- Keywords
- Enteral Nutrition, Chrononutrition, Intensive Care Unit, Chronobiology, Nutrition Support, Sleep
- Medical subject headings
- Feeding Behavior, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-of-day of enteral nutrition provision (daytime first)Dietary supplement
Enteral nutrition (tube feeds) will be provided during the daytime followed by nighttime.
Time-of-day of enteral nutrition provision (nighttime first)Dietary supplement
Enteral nutrition (tube feeds) will be provided during the nighttime followed by daytime.
| Study group | Role | What they receive |
|---|---|---|
| Nighttime cycled enteral feeds first | Experimental | 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. Receives: Dietary Supplement: Time-of-day of enteral nutrition provision (nighttime first) |
| Daytime cycled enteral feeds first | Experimental | 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. Receives: Dietary Supplement: Time-of-day of enteral nutrition provision (daytime first) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep fragmentation
Sleep fragmentation is defined as the number of shifts from deeper (N2, N3, REM) to lighter (W or N1) sleep stages by hours of sleep. Sleep fragmentation will be assessed objectively through EEG measures.
Measured: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Circadian rhythms amplitude
Amplitude is defined as peak-to-nadir difference in rhythms estimated from body temperature and actigraphy.
Measured: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Secondary outcomes (13)
Sleep arousals
Sleep arousals is defined as n shifts from N1, N2, N3, REM to wake divided by hours of sleep. Sleep arousals will be assessed objectively through EEG measures.
Measured: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Total sleep time
Measure of sleep duration and assessed objectively through EEG measures.
Measured: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Duration of sleep stages
Duration of the following sleep stages will be estimated: N1, N2, N3, REM sleep. Sleep stages will be assessed objectively through EEG measures.
Measured: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Sleep midpoint
Sleep midpoint is defined as the midpoint between start and end of sleep episode. Sleep midpoint will be determined objectively from EEG measures.
Measured: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Acrophase
Acrophase is defined as the time of peak activity.
Measured: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Midpoint of least-active 5h timing
Measure of sleep timing as determined from actigraphy.
Measured: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Midpoint of most-active 10h timing
Measure of sleep timing as determined from actigraphy.
Measured: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Inactivity duration
Duration of inactivity outside of sleep episode as determined from actigraphy.
Measured: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
12 hours average systolic and diastolic blood pressure
Continuously measured using ECG. Systolic and diastolic blood pressure will be averaged during each 12-hour cycled feed.
Measured: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
12 hours average glucose
Continuously measured using continuous glucose sensors. Blood glucose will be averaged during each 12-hour cycled feed.
Measured: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
C-reactive protein
The inflammatory biomarker C-reactive protein will be measured from serum.
Measured: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
Interleukin-6
The inflammatory biomarker Interleukin-6 will be measured from serum.
Measured: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
Tumor necrosis factor α
The inflammatory biomarker Tumor necrosis factor α will be measured from serum.
Measured: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start8 Feb 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Feeding PatternsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Dashti, Massachusetts General Hospital
- Investigators
- Hassan S Dashti, Ph.D., R.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737200
- Sponsor's protocol ID
- 2020P003989
- Status last verified
- May 2026
- First submitted
- 28 Jan 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dashti HS, Wang YM, Knauert MP. Feeding critically ill patients at the right time of day. Crit Care. 2024 Jun 24;28(1):206. doi: 10.1186/s13054-024-04994-0. No abstract available.
PubMed 38915028Luetz A, Spies C, Kervezee L. It's about time: circadian medicine in the intensive care unit. Intensive Care Med. 2024 Feb;50(2):283-286. doi: 10.1007/s00134-023-07297-0. Epub 2023 Dec 19. No abstract available.
PubMed 38112772
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
- ClinicalTrials.gov ID
- NCT04737200
- Acronym / sponsor ID
- 2020P003989
- Conditions
- Feeding Patterns, Sleep, Glucose Intolerance
- Keywords
- Enteral Nutrition, Chrononutrition, Intensive Care Unit, Chronobiology, Nutrition Support, Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intensive care unit (ICU) environments do not support sleep or preserve circadian rhythms of postoperative critically ill patients. Among the contributing factors is the common practice of administering nutrition support through feeding tubes overnight. The overall objective of the study is to examine a novel dimension of clinical nutrition by determining whether enhancing sleep quality and preserving robust circadian rhythms through daytime instead of overnight feeds will attenuate inflammation and improve cardiometabolic profiles of postoperative cardiac ICU patients on nutrition support. The investigators hypothesize that overnight nutrition support results in fragmented sleep and blunted circadian rhythms and thus represent a modifiable mechanism exacerbating inflammation and cardiometabolic derangements in postoperative cardiac patients. Results of this study will help in the development of evidence-based, cost-efficient, and effective enteral nutrition timing countermeasures against fragmented sleep, disrupted circadian rhythms, inflammation and cardiometabolic derangements and potentially modify the current widespread practice of overnight nutrition likely affecting 250,000 hospital admissions annually in the United States.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nighttime cycled enteral feeds first | Experimental | Dietary Supplement: Time-of-day of enteral nutrition provision (nighttime 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. |
| Daytime cycled enteral feeds first | Experimental | Dietary Supplement: Time-of-day of enteral nutrition provision (daytime 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-of-day of enteral nutrition provision (daytime first)Enteral nutrition (tube feeds) will be provided during the daytime followed by nighttime. | Dietary supplement | Daytime cycled enteral feeds first |
| Time-of-day of enteral nutrition provision (nighttime first)Enteral nutrition (tube feeds) will be provided during the nighttime followed by daytime. | Dietary supplement | Nighttime cycled enteral feeds first |
Primary outcome
Sleep fragmentation
Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Sleep fragmentation is defined as the number of shifts from deeper (N2, N3, REM) to lighter (W or N1) sleep stages by hours of sleep. Sleep fragmentation will be assessed objectively through EEG measures.
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.
Amplitude is defined as peak-to-nadir difference in rhythms estimated from body temperature and actigraphy.
13 secondary outcomes
Sleep arousals
Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Total sleep time
Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Duration of sleep stages
Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Sleep midpoint
Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Acrophase
Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Midpoint of least-active 5h timing
Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Midpoint of most-active 10h timing
Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Inactivity duration
Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
12 hours average systolic and diastolic blood pressure
Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
12 hours average glucose
Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
C-reactive protein
Time frame: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
Interleukin-6
Time frame: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
Tumor necrosis factor α
Time frame: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Results publication: PubMed 38915028Dashti HS, Wang YM, Knauert MP. Feeding critically ill patients at the right time of day. Crit Care. 2024 Jun 24;28(1):206. doi: 10.1186/s13054-024-04994-0. No abstract available.
- Derived from this study: PubMed 38112772Luetz A, Spies C, Kervezee L. It's about time: circadian medicine in the intensive care unit. Intensive Care Med. 2024 Feb;50(2):283-286. doi: 10.1007/s00134-023-07297-0. Epub 2023 Dec 19. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richa Saxena, Ph.D. contact
Hassan S Dashti, Ph.D., R.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-of-day of enteral nutrition provision (daytime first) and Time-of-day of enteral nutrition provision (nighttime first) in people with Feeding Patterns and Sleep, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hassan S Dashti, Ph.D., R.D. (617-643-7167, chrononutrition@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04737200, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.