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| Name | Class |
|---|---|
| ASPEN Rhoads Research Foundation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-of-day of parenteral nutrition provision | Dietary Supplement | Parenteral nutrition will be provided during the nighttime followed by daytime. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Actigraphy data from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hassan S Dashti, Ph.D., R.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38043867 | Result | 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. | |
| 37777983 |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D018149 | Glucose Intolerance |
| D012778 | Short Bowel Syndrome |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
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| 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). | 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. | 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). | 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). | 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). | 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). | Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds). |
| Result |
| 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. |
| 38901946 | Derived | Dashti 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. |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |