Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2022-10-24

Brief Summary

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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.

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Detailed Description

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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

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Feeding Patterns Sleep Glucose Intolerance Short Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nighttime cycled parenteral feeds followed by daytime cycled parenteral feeds

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.

Group Type EXPERIMENTAL

Time-of-day of parenteral nutrition provision

Intervention Type DIETARY_SUPPLEMENT

Parenteral nutrition will be provided during the nighttime followed by daytime.

Interventions

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Time-of-day of parenteral nutrition provision

Parenteral nutrition will be provided during the nighttime followed by daytime.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No