NCT04743960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

February 3, 2021

Last Update Submit

September 22, 2025

Conditions

Feeding PatternsSleepGlucose IntoleranceShort Bowel Syndrome

Keywords

Parenteral NutritionChrononutritionChronobiologyNutrition SupportSleepMetabolomics

Outcome Measures

Primary Outcomes (2)

  • 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 Ă— 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 Outcomes (7)

  • Change in area under-the-curve of glucose from nighttime to daytime feeds

    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

    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

    Blood draw scheduled on days 8 and 15.

  • Change in sleep duration from nighttime to daytime feeds

    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

    Average values from days 1 to 7 (nighttime feeds) and days 8 to 14 (daytime feeds).

  • +2 more secondary outcomes

Study Arms (1)

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.

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

Interventions

Time-of-day of parenteral nutrition provisionDIETARY_SUPPLEMENT

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

Nighttime cycled parenteral feeds followed by daytime cycled parenteral feeds

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • 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.

    PMID: 38043867BACKGROUND

  • 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.

    PMID: 37777983BACKGROUND

  • 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.

    PMID: 38901946DERIVED

MeSH Terms

Conditions

Feeding BehaviorGlucose IntoleranceShort Bowel SyndromeHyperphagia

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMalabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Study Officials

  • Hassan S Dashti, Ph.D., R.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 8, 2021

Study Start

October 5, 2021

Primary Completion

October 24, 2022

Study Completion

October 24, 2022

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)