An interventional study of Time-of-day of parenteral nutrition provision in Feeding Patterns, Sleep and Glucose Intolerance, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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.
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.
985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.
This study's enrollment of 20 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Time-of-day of parenteral nutrition provision
Parenteral nutrition will be provided during the nighttime followed by daytime.
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).
Time frame: 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.
Time frame: Actigraphy data from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
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).
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
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).
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
Serum insulin will be measured from fasting blood samples collected on day 8 and 15.
Time frame: 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).
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
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).
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
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).
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
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).
Time frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Plan to share: No
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital →