Effect of Late Dinner on Nocturnal Metabolism
The Effect of Routine vs Late Dinner on Nocturnal Metabolism and Fat Oxidation
1 other identifier
interventional
34
1 country
1
Brief Summary
This study examines the impact of routine dinner time versus late dinner time on nocturnal metabolism. Specifically, investigators will examine plasma profiles of free fatty acids, glucose, insulin, triglycerides, and oxidation of dietary fat.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started May 2018
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2018
CompletedStudy Start
First participant enrolled
May 8, 2018
CompletedFirst Posted
Study publicly available on registry
May 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedDecember 2, 2020
November 1, 2020
1.7 years
May 3, 2018
November 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Free Fatty Acids (FFA, mmol/L)
Serial blood samples taken during visit, 20 time points per visit, 2 nights
2 visits, 4 weeks apart, each visit with 20 time points to assess change over time
Glucose (mg/dl)
Serial blood samples taken during visit, 20 time points per visit, 2 nights
2 visits, 4 weeks apart, each visit with 20 time points to assess change over time
Insulin (mcU/ml)
Serial blood samples taken during visit, 20 time points per visit, 2 nights
2 visits, 4 weeks apart, each visit with 20 time points to assess change over time
Triglycerides (mg/dl)
Serial blood samples taken during visit, 20 time points per visit, 2 nights
2 visits, 4 weeks apart, each visit with 20 time points to assess change over time
Oxidation of palmitate (mass spectroscopy)
Serial blood samples taken during visit, 20 time points per visit, 2 nights
2 visits, 4 weeks apart, each visit with 20 time points to assess change over time
Secondary Outcomes (1)
Polysomnography
1 sleep study per visit, 4 weeks apart
Study Arms (2)
Routine Dinner
ACTIVE COMPARATORParticipants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at "routine" dinner time (18:00) followed by a sleep study (23:00). Timing of dinner is the sole intervention distinguishing this arm from late dinner. This arm will cross-over to late dinner in random order.
Late Dinner
EXPERIMENTALParticipants will be served dinner and a stable isotope of palmitate to measure fat oxidation, at a "late" dinner time (22:00) followed by a sleep study (23:00). Timing of dinner is the sole intervention distinguishing this arm from routine dinner. This arm will cross-over to routine dinner in random order.
Interventions
Participants will be served dinner at a routine time (18:00), along with with a stable isotope of palmitate to measure fat oxidation overnight.
Participants will be served dinner at a late time (22:00), along with with a stable isotope of palmitate to measure fat oxidation overnight.
Eligibility Criteria
You may qualify if:
- Healthy male and female adult volunteers, age 18-30.
- Accustomed to a bedtime between 10:00 PM and 1:00 AM.
You may not qualify if:
- Sleep disorder including insomnia, sleep apnea, circadian rhythm disorder, restless leg syndrome, narcolepsy, shift work sleep disorder
- Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bed time.
- Chronic use of sedative hypnotics, anxiolytics, opiates
- Use of medications that can affect circadian rhythm (beta blockers, melatonin)
- Active smoking (may interfere with metabolism and CRU activities)
- Diabetes (type 1 or 2)
- Obesity (BMI≥30)
- Pregnant or lactating female (pregnancy test will be required)
- Professional or collegiate athlete
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Related Publications (1)
Gu C, Brereton N, Schweitzer A, Cotter M, Duan D, Borsheim E, Wolfe RR, Pham LV, Polotsky VY, Jun JC. Metabolic Effects of Late Dinner in Healthy Volunteers-A Randomized Crossover Clinical Trial. J Clin Endocrinol Metab. 2020 Aug 1;105(8):2789-802. doi: 10.1210/clinem/dgaa354.
PMID: 32525525DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Jun, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2018
First Posted
May 16, 2018
Study Start
May 8, 2018
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
December 2, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The data will be provided upon request within 1 year after publication and will be available to indefinitely.
- Access Criteria
- The PI will accept requests from other researchers who are examining pertinent outcomes.
We will provide raw data (without identifying information) to journals or other researchers upon request.