Feeding PatternsNCT04743960
Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition
A study testing Time-of-day of parenteral nutrition provision 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 advancing the timing of home parenteral nutrition from overnight to daytime regimens leads to improved glucose profiles and sleep quality, and other changes in plasma metabolic signatures. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Feeding Patterns, Sleep, Glucose Intolerance
- What is being tested?
- Time-of-day of parenteral nutrition provision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 24 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or non-pregnant female volunteers (age 18-79)
- Short bowel syndrome diagnosis
- Able and willing to give consent and comply with study procedures
- Currently on routine home parenteral nutrition (at least 6 months)
Who cannot join
- Blind, deaf or unable to speak English
- Women who are pregnant or nursing
- Diabetes diagnosis or currently taking or intending to take any diabetes medication or medications influencing sugars including oral glucocorticoids, growth hormone, erythropoietin, or chemotherapeutic
- Current use of sleep medication and melatonin
- With skin condition that precludes wearing sensors
- Within the last year, bariatric surgery or pregnancy
Show all 10Show fewer
- Within the last one month, acute infections or illnesses requiring medical attention, hospitalizations, Emergency Department visits, blood transfusions, blood loss, blood donations
- Major changes in diet or physical activity level in the past 3 months
- Sleep and circadian disorders (such as obstructive sleep apnea and delayed sleep phase syndrome)
- Anticipated barriers or challenges to daytime and/or overnight cycled infusions
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to determine whether advancing the timing of home parenteral nutrition from overnight to daytime regimens leads to improved glucose profiles and sleep quality, and other changes in plasma metabolic signatures.
Read the detailed description
Emerging evidence suggests that considering the time-of-day in clinical care may optimize health, partly through limiting sleep disruption and circadian misalignment. Acute sleep and circadian rhythms disturbances are associated with cardiometabolic derangements, including persistent hyperglycemia, a significant contributor to life-threatening complications. However, it is currently considered standard practice for patients on parenteral nutrition to be fed for 12-hour periods overnight. Current guidelines lack explicit guidance regarding the time-of-day when nutrition support should be administered. Thus, the overall objective of the clinical trial is to comprehensively examine a novel dimension of clinical nutrition by determining whether advancing the timing of home parenteral nutrition from overnight to daytime regimens leads to improved glucose profiles and sleep quality, and other changes in plasma metabolic signatures. The study is a 2-week controlled cross-over feeding trial where 20 short bowel syndrome patients will follow their usual overnight parenteral nutrition regimen for one week, and then advance their feeds to daytime for a second week. Patients will be assessed objectively using non-invasive, novel technologies and 'omics techniques. The investigators hypothesize that advancing the timing of home parenteral nutrition feeds to a daytime regimen is a cost-efficient, effective, and feasible nutrition timing countermeasure against metabolic derangements, fragmented sleep, and decreased quality of life. Results of this study may provide evidence-based, cost-efficient, and effective nutrition support countermeasures against hyperglycemia and sleep disruption, and could potentially modify current widespread clinical nutrition support practice.
- Conditions
- Feeding Patterns, Sleep, Glucose Intolerance, Short Bowel Syndrome
- Being tested
- Time-of-day of parenteral nutrition provision
- Keywords
- Parenteral Nutrition, Chrononutrition, Chronobiology, Nutrition Support, Sleep, Metabolomics
- Medical subject headings
- Feeding Behavior, Glucose Intolerance, Short Bowel Syndrome, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-of-day of parenteral nutrition provisionDietary supplement
Parenteral nutrition will be provided during the nighttime followed by daytime.
| Study group | Role | What they receive |
|---|---|---|
| Nighttime cycled parenteral feeds followed by daytime cycled parenteral feeds | Experimental | Patients will follow nighttime feeding regimen for one week, and then advance their feeds (approximately 12 hours earlier) to daytime feeding regimen for one week. Receives: Dietary Supplement: Time-of-day of parenteral nutrition provision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour average glucose from nighttime to daytime feeds
Glucose will be continuously measured using continuous glucose sensors. Blood glucose will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).
Measured: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Change in number of interruptions of sleep by physical movement assessed by actigraphy from nighttime to daytime feeds
Sleep will be objectively measured from actigraphy. The number of interruptions of sleep by physical movement will be calculated as 100 × the number of groups of consecutive mobile 30-s epochs/by the total number of immobile epochs. This measure will reflect sleep quality.
Measured: Actigraphy data from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Secondary outcomes (7)
Change in area under-the-curve of glucose from nighttime to daytime feeds
Glucose will be continuously measured using continuous glucose sensors. Area under-the-curve of blood glucose during the 12-hour feeds will be calculated using the trapezoid method and adjusted for baseline glucose values. Area under-the-curve of glucose will be averaged for each of the two 1-week feeding regimens (nighttime and daytime).
Measured: Glucose values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds) during 12-hour cycled feeds.
Change in average daily duration of glucose levels above 140 mg/dl from nighttime to daytime feeds
Glucose will be continuously measured using continuous glucose sensors. Duration of glucose levels above 140 mg/dl will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).
Measured: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Change in fasting insulin concentration from nighttime to daytime feeds
Serum insulin will be measured from fasting blood samples collected on day 8 and 15.
Measured: Blood draw scheduled on days 8 and 15.
Change in sleep duration from nighttime to daytime feeds
Sleep duration will be objectively measured from actigraphy and sleep logs. Duration will be averaged will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).
Measured: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Change in sleep midpoint from nighttime to daytime feeds
Sleep midpoint will be objectively measured from actigraphy and sleep logs. Midpoint will be averaged will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).
Measured: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Change in midpoint of least-active 5h timing from nighttime to daytime feeds
Measure of sleep timing as determined from actigraphy. Timing will be averaged will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).
Measured: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Change in midpoint of most-active 10h timing from nighttime to daytime feeds
Measure of sleep timing as determined from actigraphy. Timing will be averaged will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).
Measured: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start5 Oct 2021
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ASPEN Rhoads Research Foundation
- 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
- NCT04743960
- Sponsor's protocol ID
- 2020P003741
- Status last verified
- Sep 2025
- First submitted
- 3 Feb 2021
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dashti HS, Leong A, Mogensen KM, Annambhotla M, Li P, Deng H, Carey AN, Burns DL, Winkler MF, Compher C, Saxena R. Glycemic and sleep effects of daytime compared with those of overnight infusions of home parenteral nutrition in adults with short bowel syndrome: A quasi-experimental pilot trial. Am J Clin Nutr. 2024 Feb;119(2):569-577. doi: 10.1016/j.ajcnut.2023.11.016. Epub 2023 Dec 1.
PubMed 38043867Rahmoune A, Winkler MF, Saxena R, Compher C, Dashti HS. Comparison between self-reported and actigraphy-derived sleep measures in patients receiving home parenteral nutrition: Secondary analysis of observational data. Nutr Clin Pract. 2024 Apr;39(2):426-436. doi: 10.1002/ncp.11077. Epub 2023 Oct 1.
PubMed 37777983Dashti HS, Sevilla-Gonzalez M, Mogensen KM, Winkler MF, Compher C. Plasma metabolomics changes comparing daytime to overnight infusions of home parenteral nutrition in adult patients with short bowel syndrome: Secondary analysis of a clinical trial. Clin Nutr ESPEN. 2024 Aug;62:28-32. doi: 10.1016/j.clnesp.2024.04.025. Epub 2024 May 13.
PubMed 38901946
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT04743960
- Acronym / sponsor ID
- 2020P003741
- Conditions
- Feeding Patterns, Sleep, Glucose Intolerance, Short Bowel Syndrome
- Keywords
- Parenteral Nutrition, Chrononutrition, Chronobiology, Nutrition Support, Sleep, Metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- ASPEN Rhoads Research Foundation
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 8 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 advancing the timing of home parenteral nutrition from overnight to daytime regimens leads to improved glucose profiles and sleep quality, and other changes in plasma metabolic signatures.
Detailed description
Emerging evidence suggests that considering the time-of-day in clinical care may optimize health, partly through limiting sleep disruption and circadian misalignment. Acute sleep and circadian rhythms disturbances are associated with cardiometabolic derangements, including persistent hyperglycemia, a significant contributor to life-threatening complications. However, it is currently considered standard practice for patients on parenteral nutrition to be fed for 12-hour periods overnight. Current guidelines lack explicit guidance regarding the time-of-day when nutrition support should be administered. Thus, the overall objective of the clinical trial is to comprehensively examine a novel dimension of clinical nutrition by determining whether advancing the timing of home parenteral nutrition from overnight to daytime regimens leads to improved glucose profiles and sleep quality, and other changes in plasma metabolic signatures. The study is a 2-week controlled cross-over feeding trial where 20 short bowel syndrome patients will follow their usual overnight parenteral nutrition regimen for one week, and then advance their feeds to daytime for a second week. Patients will be assessed objectively using non-invasive, novel technologies and 'omics techniques. The investigators hypothesize that advancing the timing of home parenteral nutrition feeds to a daytime regimen is a cost-efficient, effective, and feasible nutrition timing countermeasure against metabolic derangements, fragmented sleep, and decreased quality of life. Results of this study may provide evidence-based, cost-efficient, and effective nutrition support countermeasures against hyperglycemia and sleep disruption, and could potentially modify current widespread clinical nutrition support practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nighttime cycled parenteral feeds followed by daytime cycled parenteral feeds | Experimental | Dietary Supplement: Time-of-day of parenteral nutrition provisionPatients will follow nighttime feeding regimen for one week, and then advance their feeds (approximately 12 hours earlier) to daytime feeding regimen for one week. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult male or non-pregnant female volunteers (age 18-79)
- Short bowel syndrome diagnosis
- Able and willing to give consent and comply with study procedures
- Currently on routine home parenteral nutrition (at least 6 months)
Key exclusion criteria (10 listed)
- Blind, deaf or unable to speak English
- Women who are pregnant or nursing
- Diabetes diagnosis or currently taking or intending to take any diabetes medication or medications influencing sugars including oral glucocorticoids, growth hormone, erythropoietin, or chemotherapeutic
- Current use of sleep medication and melatonin
- With skin condition that precludes wearing sensors
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 parenteral nutrition provisionParenteral nutrition will be provided during the nighttime followed by daytime. | Dietary supplement | Nighttime cycled parenteral feeds followed by daytime cycled parenteral feeds |
Primary outcome
Change in 24-hour average glucose from nighttime to daytime feeds
Time frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Glucose will be continuously measured using continuous glucose sensors. Blood glucose will be averaged during each of the two 1-week feeding regimens (nighttime and daytime).
Change in number of interruptions of sleep by physical movement assessed by actigraphy from nighttime to daytime feeds
Time frame: Actigraphy data from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Sleep will be objectively measured from actigraphy. The number of interruptions of sleep by physical movement will be calculated as 100 × the number of groups of consecutive mobile 30-s epochs/by the total number of immobile epochs. This measure will reflect sleep quality.
7 secondary outcomes
Change in area under-the-curve of glucose from nighttime to daytime feeds
Time frame: Glucose values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds) during 12-hour cycled feeds.
Change in average daily duration of glucose levels above 140 mg/dl from nighttime to daytime feeds
Time frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Change in fasting insulin concentration from nighttime to daytime feeds
Time frame: Blood draw scheduled on days 8 and 15.
Change in sleep duration from nighttime to daytime feeds
Time frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Change in sleep midpoint from nighttime to daytime feeds
Time frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Change in midpoint of least-active 5h timing from nighttime to daytime feeds
Time frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Change in midpoint of most-active 10h timing from nighttime to daytime feeds
Time frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Results publication: PubMed 38043867Dashti HS, Leong A, Mogensen KM, Annambhotla M, Li P, Deng H, Carey AN, Burns DL, Winkler MF, Compher C, Saxena R. Glycemic and sleep effects of daytime compared with those of overnight infusions of home parenteral nutrition in adults with short bowel syndrome: A quasi-experimental pilot trial. Am J Clin Nutr. 2024 Feb;119(2):569-577. doi: 10.1016/j.ajcnut.2023.11.016. Epub 2023 Dec 1.
- Results publication: PubMed 37777983Rahmoune A, Winkler MF, Saxena R, Compher C, Dashti HS. Comparison between self-reported and actigraphy-derived sleep measures in patients receiving home parenteral nutrition: Secondary analysis of observational data. Nutr Clin Pract. 2024 Apr;39(2):426-436. doi: 10.1002/ncp.11077. Epub 2023 Oct 1.
- Derived from this study: PubMed 38901946Dashti HS, Sevilla-Gonzalez M, Mogensen KM, Winkler MF, Compher C. Plasma metabolomics changes comparing daytime to overnight infusions of home parenteral nutrition in adult patients with short bowel syndrome: Secondary analysis of a clinical trial. Clin Nutr ESPEN. 2024 Aug;62:28-32. doi: 10.1016/j.clnesp.2024.04.025. Epub 2024 May 13.
- 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. This study is not recruiting at the moment.
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 parenteral nutrition provision 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 25 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour average glucose from nighttime to daytime feeds (time frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime 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 NCT04743960, which also lists 3 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 25 Sep 2025.