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Dinner Time for Obesity and Prediabetes (DTOP)

Primary Purpose

PreDiabetes, Obesity, Healthy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Dinner
Late Dinner
Early Dinner tracer
Late Dinner tracer
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for PreDiabetes focused on measuring circadian, sleep, glucose, metabolism

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

The investigators are enrolling both Normal-Weight Healthy (NWH) and Obesity-Prediabetes (OPD) research participants. At this time (5/2023) the investigators are focusing on the NWH group. Inclusion Criteria: For the Normal-Weight Healthy (NWH) cohort: Healthy male and female adults, age 18-50, with BMI 18-24.9 kg/m2 inclusively For the Obesity-Prediabetes (OPD) cohort: Male and female adults, age 18-50, with BMI ≥30 kg/m2 and prediabetes All participants must be able to understand study procedures and to comply with the procedures for the entire length of the study. Exclusion Criteria: Sleep disorder including insomnia, untreated moderate-severe sleep apnea, restless leg syndrome, or narcolepsy Night shift work Extreme delayed sleep phase defined as self-reported routine bedtime later than 1:00 AM or having mid-sleep on free days later than 5:00 AM on the Munich Chronotype Questionnaire (MCTQ) or DLMO later than 24:00 Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bedtime Active smoking Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Diabetes (type 1 or 2) or on any diabetes medications besides metformin Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, thyroid disease) Hemoglobin A1c ≥5.7% for NWH cohort; Hemoglobin A1c ≥6.5% for OPD cohort Hemoglobin < 10 g/dL Self-reported kidney disease Any known history of an inherited metabolic disorder Pregnant or lactating female (pregnancy test will be required prior to metabolic visits) Peri-menopausal or post-menopausal female as determined by follicle stimulating hormone of > 30 mIU/mL or fewer than 3 menstrual periods in 6 months Professional or collegiate athlete Travel across >1 time zone within a 3-month period before and during the protocol Weight less than 40 kg or more than 180 kg Gastrointestinal disorders that can lead to obstruction of the digestive tract (i.e. diverticular disease, history of bowel obstruction, inflammatory bowel disease, motility disorder) History of any surgical procedures in the gastrointestinal tract. Swallowing disorders Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team) Chronic use of sedative hypnotics, anxiolytics, opiates Use of medications that can affect circadian rhythm (beta blockers, melatonin) Presence of a cardiac pacemaker or other implanted electro-medical devices Those who have to undergo strong electromagnetic field during the period of use of the ingestible thermosensor (i.e. MRI) Weight loss or gain of ≥ 5% of total body weight over the preceding 3 months Currently participating in a weight loss program Prior bariatric surgery Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) History of significant intravenous access issues Non-English speaking individuals: The complexity of the instructions for various components of the study would make the study procedures difficult to follow in the setting of a language barrier. Other conditions or situations at the discretion of the PI

Sites / Locations

  • Johns Hopkins Bayview Medical CenterRecruiting
  • National Institutes of Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early Dinner First

Late Dinner First

Arm Description

Participants will be served dinner and a stable isotope of oral [2H31] palmitate to measure fat oxidation, at an early dinner time (before DLMO). This arm will then cross-over to Late Dinner as the second metabolic visit.

Participants will be served dinner and a stable isotope of oral [2H31] palmitate to measure fat oxidation, at a late dinner time (after DLMO). This arm will then cross-over to Early Dinner as the second metabolic visit.

Outcomes

Primary Outcome Measures

24-hour total fat oxidation
Within-subject difference in total fat oxidation between early dinner and late dinner conditions.

Secondary Outcome Measures

4-hour post-prandial area-under-the-curve (AUC) glucose levels
Within-subject difference in post-prandial AUC glucose levels between early dinner and late dinner conditions.
4-hour post-prandial area-under-the-curve insulin levels
Within-subject difference in post-prandial AUC insulin levels between early dinner and late dinner conditions.
14-hour post-dinner cumulative dietary fat oxidation
Within-subject difference in dietary fat oxidation between early dinner and late dinner conditions.

Full Information

First Posted
February 8, 2023
Last Updated
July 17, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05745441
Brief Title
Dinner Time for Obesity and Prediabetes
Acronym
DTOP
Official Title
Dinner Time for Obesity and Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Obesity and its metabolic complications are leading causes of global morbidity and mortality. Evidence is mounting that inappropriate timing of food intake contributes to obesity. Specifically, late eating is associated with greater weight gain and metabolic syndrome. However, the mechanism by which late eating harms metabolism is not fully understood but may be related to mis-timing of food intake in relation to the body's endogenous circadian rhythm. Conversely, harmonization of eating timing with endogenous circadian rhythm may optimize metabolic health. In this study the investigators will use gold-standard methods of characterizing circadian rhythm in humans to examine the metabolic impacts food timing relative to endogenous circadian rhythm.
Detailed Description
This is a randomized, cross-over study that examines the metabolic impact of early vs late dinner, as defined by proximity of food intake to an individual's biological night as determined by dim light melatonin onset (DLMO) in normal-weight, healthy adult volunteers and in adults with obesity and prediabetes. Each participant will first undergo circadian phenotyping at the Johns Hopkins Bayview Clinical Research Unit (Baltimore, Maryland), with assessment of DLMO and core body temperature profile, as well as wrist actigraphy. Thereafter, participants will be crossover randomized to (1) a 24-hour metabolic chamber protocol where dinner is eaten 3 hours before DLMO (early dinner), or (2) a 24-hour metabolic chamber protocol where dinner is 1 hour eaten after DLMO (late dinner), both to be performed at the NIH Metabolic Clinical Research Unit (Bethesda, Maryland). The timing and nutritional contents of all meals, as well as sleep timing and duration, will be held constant. Oral [2H31] palmitate will be given with each dinner condition to quantify dietary fat oxidation. The 2 dinner conditions will occur in random order, with a 3- to 4-week washout period. The investigators are enrolling both Normal-Weight Healthy (NWH) and Obesity-Prediabetes (OPD) research participants. At this time (5/2023) the investigators are focusing on the NWH group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Obesity, Healthy
Keywords
circadian, sleep, glucose, metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Dinner First
Arm Type
Experimental
Arm Description
Participants will be served dinner and a stable isotope of oral [2H31] palmitate to measure fat oxidation, at an early dinner time (before DLMO). This arm will then cross-over to Late Dinner as the second metabolic visit.
Arm Title
Late Dinner First
Arm Type
Experimental
Arm Description
Participants will be served dinner and a stable isotope of oral [2H31] palmitate to measure fat oxidation, at a late dinner time (after DLMO). This arm will then cross-over to Early Dinner as the second metabolic visit.
Intervention Type
Behavioral
Intervention Name(s)
Early Dinner
Intervention Description
Dinner before DLMO
Intervention Type
Behavioral
Intervention Name(s)
Late Dinner
Intervention Description
Dinner after DLMO
Intervention Type
Drug
Intervention Name(s)
Early Dinner tracer
Intervention Description
Stable isotope of oral [2H31] palmitate to measure fat oxidation, given with dinner before DLMO
Intervention Type
Drug
Intervention Name(s)
Late Dinner tracer
Intervention Description
Stable isotope of oral [2H31] palmitate to measure fat oxidation, given with dinner after DLMO
Primary Outcome Measure Information:
Title
24-hour total fat oxidation
Description
Within-subject difference in total fat oxidation between early dinner and late dinner conditions.
Time Frame
baseline, 4 weeks
Secondary Outcome Measure Information:
Title
4-hour post-prandial area-under-the-curve (AUC) glucose levels
Description
Within-subject difference in post-prandial AUC glucose levels between early dinner and late dinner conditions.
Time Frame
baseline, 4 weeks
Title
4-hour post-prandial area-under-the-curve insulin levels
Description
Within-subject difference in post-prandial AUC insulin levels between early dinner and late dinner conditions.
Time Frame
baseline, 4 weeks
Title
14-hour post-dinner cumulative dietary fat oxidation
Description
Within-subject difference in dietary fat oxidation between early dinner and late dinner conditions.
Time Frame
baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The investigators are enrolling both Normal-Weight Healthy (NWH) and Obesity-Prediabetes (OPD) research participants. At this time (5/2023) the investigators are focusing on the NWH group. Inclusion Criteria: For the Normal-Weight Healthy (NWH) cohort: Healthy male and female adults, age 18-50, with BMI 18-24.9 kg/m2 inclusively For the Obesity-Prediabetes (OPD) cohort: Male and female adults, age 18-50, with BMI ≥30 kg/m2 and prediabetes All participants must be able to understand study procedures and to comply with the procedures for the entire length of the study. Exclusion Criteria: Sleep disorder including insomnia, untreated moderate-severe sleep apnea, restless leg syndrome, or narcolepsy Night shift work Extreme delayed sleep phase defined as self-reported routine bedtime later than 1:00 AM or having mid-sleep on free days later than 5:00 AM on the Munich Chronotype Questionnaire (MCTQ) or DLMO later than 24:00 Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bedtime Active smoking Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Diabetes (type 1 or 2) or on any diabetes medications besides metformin Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, thyroid disease) Hemoglobin A1c ≥5.7% for NWH cohort; Hemoglobin A1c ≥6.5% for OPD cohort Hemoglobin < 10 g/dL Self-reported kidney disease Any known history of an inherited metabolic disorder Pregnant or lactating female (pregnancy test will be required prior to metabolic visits) Peri-menopausal or post-menopausal female as determined by follicle stimulating hormone of > 30 mIU/mL or fewer than 3 menstrual periods in 6 months Professional or collegiate athlete Travel across >1 time zone within a 3-month period before and during the protocol Weight less than 40 kg or more than 180 kg Gastrointestinal disorders that can lead to obstruction of the digestive tract (i.e. diverticular disease, history of bowel obstruction, inflammatory bowel disease, motility disorder) History of any surgical procedures in the gastrointestinal tract. Swallowing disorders Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team) Chronic use of sedative hypnotics, anxiolytics, opiates Use of medications that can affect circadian rhythm (beta blockers, melatonin) Presence of a cardiac pacemaker or other implanted electro-medical devices Those who have to undergo strong electromagnetic field during the period of use of the ingestible thermosensor (i.e. MRI) Weight loss or gain of ≥ 5% of total body weight over the preceding 3 months Currently participating in a weight loss program Prior bariatric surgery Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) History of significant intravenous access issues Non-English speaking individuals: The complexity of the instructions for various components of the study would make the study procedures difficult to follow in the setting of a language barrier. Other conditions or situations at the discretion of the PI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Athena Mavronis
Phone
(410) 550-4588
Email
amavron1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mariah Potocki
Phone
410-550-2233
Email
mchaney7@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Jun, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephanie T Chung, MBBS
Organizational Affiliation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athena Mavronis
Phone
410-550-4588
Email
amavron1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Jun, MD
Phone
410-550-0115
Email
jjun2@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Jun, MD
First Name & Middle Initial & Last Name & Degree
Daisy Duan, MD
First Name & Middle Initial & Last Name & Degree
Luu Pham, MD
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie T Chung, MBBS
Phone
240-479-8137
Email
stephanie.chung@nih.gov
First Name & Middle Initial & Last Name & Degree
Lilian Mabundo, RN, MSN
Phone
240-383-9379
Email
lilian.mabundo@nih.gov
First Name & Middle Initial & Last Name & Degree
Stephanie T Chung, MBBS
First Name & Middle Initial & Last Name & Degree
Kong Y Chen, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators will provide raw data (without identifying information) to journals or other researchers upon request.
IPD Sharing Time Frame
The data will be provided upon request within 1 year after publication and will be available to indefinitely.
IPD Sharing Access Criteria
The PI will accept requests from other researchers who are examining pertinent outcomes.
Citations:
PubMed Identifier
32525525
Citation
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.
Results Reference
background
PubMed Identifier
34017207
Citation
Duan D, Gu C, Polotsky VY, Jun JC, Pham LV. Effects of Dinner Timing on Sleep Stage Distribution and EEG Power Spectrum in Healthy Volunteers. Nat Sci Sleep. 2021 May 14;13:601-612. doi: 10.2147/NSS.S301113. eCollection 2021.
Results Reference
background
Links:
URL
https://mrprcbcw.hosts.jhmi.edu/redcap/surveys/?s=LNACF9KWWDCCRXJ9
Description
Screening Survey for DTOP

Learn more about this trial

Dinner Time for Obesity and Prediabetes

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