Clinical trial NCT04743960: Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition
Official title: Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Patterns
Sleep
Glucose Intolerance
Short Bowel Syndrome
Keywords: Parenteral Nutrition
Chrononutrition
Chronobiology
Nutrition Support
Sleep
Metabolomics
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: ASPEN Rhoads Research Foundation
First posted: 2021-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in 24-hour average glucose from nighttime to daytime feeds
timeFrame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
measure: Change in number of interruptions of sleep by physical movement assessed by actigraphy from nighttime to daytime feeds
timeFrame: Actigraphy data from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Secondary outcomes:
measure: Change in area under-the-curve of glucose from nighttime to daytime feeds
timeFrame: Glucose values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds) during 12-hour cycled feeds.
measure: Change in average daily duration of glucose levels above 140 mg/dl from nighttime to daytime feeds
timeFrame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
measure: Change in fasting insulin concentration from nighttime to daytime feeds
timeFrame: Blood draw scheduled on days 8 and 15.
measure: Change in sleep duration from nighttime to daytime feeds
timeFrame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
measure: Change in sleep midpoint from nighttime to daytime feeds
timeFrame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
measure: Change in midpoint of least-active 5h timing from nighttime to daytime feeds
timeFrame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
measure: Change in midpoint of most-active 10h timing from nighttime to daytime feeds
timeFrame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Hassan S Dashti, Ph.D., R.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahmoune 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.
citation: 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.