Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition

September 22, 2025 updated by: Hassan Dashti, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: Time-of-day of parenteral nutrition provision
Parenteral nutrition will be provided during the nighttime followed by daytime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 24-hour average glucose from nighttime to daytime feeds
Time Frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (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
Time Frame: Actigraphy data from days 1 to 7 (nighttime feeds) and days 8 to 14 (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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in area under-the-curve of glucose from nighttime to daytime feeds
Time Frame: Glucose values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds) during 12-hour cycled 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).
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
Time Frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (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
Time Frame: Blood draw scheduled on days 8 and 15.
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
Time Frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (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
Time Frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (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
Time Frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (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
Time Frame: Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

ASPEN Rhoads Research Foundation

Investigators

  • Principal Investigator: Hassan S Dashti, Ph.D., R.D., Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2021

Primary Completion (Actual)

October 24, 2022

Study Completion (Actual)

October 24, 2022

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P003741

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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