Effect of Dietary Habits on Metabolic Health
Primary Purpose
Overweight, Obesity, Prediabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal schedule
Sponsored by
About this trial
This is an interventional basic science trial for Overweight focused on measuring Dietary Habits, Circadian, Metabolism, Feeding Behavior
Eligibility Criteria
Inclusion Criteria:
- BMI between 25 and 37.9 kgm-2
- Adults with regular sleep-wake timing
- Non-smokers
- Completion of medical and psychological screening tests
- Able to spend 14 consecutive days in the sleep laboratory
Exclusion Criteria:
- BMI < 25 or > 37.9 kgm-2
- History of neurological or psychiatric disorder
- History of sleep disorder or regular use of sleep-promoting medication
- Current prescription, herbal, or over-the-counter medication use
- Traveling across 2 or more time zones within past 3 months
- Donating blood within past 8 weeks
- Worked night or rotating shift work within past 3 years
- Hearing impairment
- Drug or alcohol dependency
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Early Meals
Late Meals
Arm Description
Meals are eaten early in the wake episode
Meals are eaten late in the wake episode
Outcomes
Primary Outcome Measures
Change in plasma leptin levels across sleep/wake cycle
Frequent blood samples
Change in circadian profile of plasma leptin
Frequent blood samples
Change in glucose tolerance
Frequent blood samples
Change in circadian profile of plasma glucose levels
Frequent blood samples
Change in plasma insulin levels after standardized test meal
Frequent blood samples
Change in circadian profile of plasma insulin levels
Frequent blood samples
Secondary Outcome Measures
Change in circadian phase markers, such as from core body temperature, melatonin, cortisol
Core temperature and frequent blood samples
Changes circadian rhythm in resting energy expenditure
Indirect calorimetry
Change in hunger and appetite, mood, and cognitive performance
Subjective ratings and cognitive tests performed via computer interface
Changes in microbiota, gene expression, epigenetic or proteomic markers
Frequent blood samples and saliva samples
Changes in sleep
Polysomnography
Change in insulin sensitivity, gene expression, epigenetic, lipidomic or proteomic markers from isolated adipocytes
2 fat biopsies, one sample will be taken during each protocol
Full Information
NCT ID
NCT02298790
First Posted
November 20, 2014
Last Updated
November 2, 2020
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02298790
Brief Title
Effect of Dietary Habits on Metabolic Health
Official Title
Effect of Dietary Habits on Metabolic Health
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 21, 2019 (Actual)
Study Completion Date
April 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this application is to understand the connection between people's eating habits and the risk for developing diabetes, obesity, and cardiovascular disease.
Detailed Description
More than a third of U.S. adults are obese (BMI greater than 30), 8-12% of adults suffer from type 2 diabetes, and up to 30% of adults have pre-diabetes. Recent research studies have suggested that it is not just what we eat, but also when we eat that may put us at risk for obesity and type 2 diabetes. Skipping breakfast and eating late at night have been associated with an increased risk for obesity and type 2 diabetes (T2D), substantiated by recent animal and human experimental studies showing that altered meal timing itself, without changes in caloric intake, can influence weight regulation and impaired glucose tolerance. This research will determine in prediabetic and non-diabetic participants whether delaying meal times worsens glucose tolerance, leads to physiological changes favoring a positive energy balance, and increases caloric intake. This research will provide mechanistic insights into the metabolic consequences of changing meal timing and may help in evidence-based approaches to improve dietary interventions in the fight against obesity and T2D.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Prediabetes, Meals
Keywords
Dietary Habits, Circadian, Metabolism, Feeding Behavior
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Meals
Arm Type
Experimental
Arm Description
Meals are eaten early in the wake episode
Arm Title
Late Meals
Arm Type
Experimental
Arm Description
Meals are eaten late in the wake episode
Intervention Type
Behavioral
Intervention Name(s)
Meal schedule
Primary Outcome Measure Information:
Title
Change in plasma leptin levels across sleep/wake cycle
Description
Frequent blood samples
Time Frame
During standardized meals scheduled on Days 3 and 6
Title
Change in circadian profile of plasma leptin
Description
Frequent blood samples
Time Frame
During constant routine (Days 7-8)
Title
Change in glucose tolerance
Description
Frequent blood samples
Time Frame
During standardized meals scheduled on Days 3 and 6
Title
Change in circadian profile of plasma glucose levels
Description
Frequent blood samples
Time Frame
During constant routine (Days 7-8)
Title
Change in plasma insulin levels after standardized test meal
Description
Frequent blood samples
Time Frame
During standardized meals scheduled on Days 3 and 6
Title
Change in circadian profile of plasma insulin levels
Description
Frequent blood samples
Time Frame
During constant routine (Days 7-8)
Secondary Outcome Measure Information:
Title
Change in circadian phase markers, such as from core body temperature, melatonin, cortisol
Description
Core temperature and frequent blood samples
Time Frame
During constant routine (Days 7-8)
Title
Changes circadian rhythm in resting energy expenditure
Description
Indirect calorimetry
Time Frame
During constant routine (Days 7-8)
Title
Change in hunger and appetite, mood, and cognitive performance
Description
Subjective ratings and cognitive tests performed via computer interface
Time Frame
Tests taken throughout the protocol, Days 1-9
Title
Changes in microbiota, gene expression, epigenetic or proteomic markers
Description
Frequent blood samples and saliva samples
Time Frame
Throughout the protocol during Days 3 and 6, and during constant routine (Days 7-8)
Title
Changes in sleep
Description
Polysomnography
Time Frame
Sleep will be measured during the night after Days 2 and 5
Title
Change in insulin sensitivity, gene expression, epigenetic, lipidomic or proteomic markers from isolated adipocytes
Description
2 fat biopsies, one sample will be taken during each protocol
Time Frame
On Day 5 of each protocol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI between 25 and 37.9 kgm-2
Adults with regular sleep-wake timing
Non-smokers
Completion of medical and psychological screening tests
Able to spend 14 consecutive days in the sleep laboratory
Exclusion Criteria:
BMI < 25 or > 37.9 kgm-2
History of neurological or psychiatric disorder
History of sleep disorder or regular use of sleep-promoting medication
Current prescription, herbal, or over-the-counter medication use
Traveling across 2 or more time zones within past 3 months
Donating blood within past 8 weeks
Worked night or rotating shift work within past 3 years
Hearing impairment
Drug or alcohol dependency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank AJL Scheer, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36198293
Citation
Vujovic N, Piron MJ, Qian J, Chellappa SL, Nedeltcheva A, Barr D, Heng SW, Kerlin K, Srivastav S, Wang W, Shoji B, Garaulet M, Brady MJ, Scheer FAJL. Late isocaloric eating increases hunger, decreases energy expenditure, and modifies metabolic pathways in adults with overweight and obesity. Cell Metab. 2022 Oct 4;34(10):1486-1498.e7. doi: 10.1016/j.cmet.2022.09.007.
Results Reference
derived
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Effect of Dietary Habits on Metabolic Health
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