Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition

Mass General Brigham

Status: Completed

Conditions: Short Bowel Syndrome; Glucose Intolerance; Sleep; Feeding Patterns

Treatments: Dietary Supplement: Time-of-day of parenteral nutrition provision

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04743960

2020P003741

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Nighttime cycled parenteral feeds followed by daytime cycled parenteral feeds

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Time-of-day of parenteral nutrition provision