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Effect of Dietary Habits on Metabolic Health

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ClinicalTrials.gov Identifier: NCT02298790
Recruitment Status : Recruiting
First Posted : November 24, 2014
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Frank AJL Scheer, PhD, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Prediabetes Meals Behavioral: Meal schedule Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of Dietary Habits on Metabolic Health
Study Start Date : November 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Early Meals
Meals are eaten early in the wake episode
Behavioral: Meal schedule
Experimental: Late Meals
Meals are eaten late in the wake episode
Behavioral: Meal schedule



Primary Outcome Measures :
  1. Change in plasma leptin levels across sleep/wake cycle [ Time Frame: During standardized meals scheduled on Days 3 and 6 ]
    Frequent blood samples

  2. Change in circadian profile of plasma leptin [ Time Frame: During constant routine (Days 7-8) ]
    Frequent blood samples

  3. Change in glucose tolerance [ Time Frame: During standardized meals scheduled on Days 3 and 6 ]
    Frequent blood samples

  4. Change in circadian profile of plasma glucose levels [ Time Frame: During constant routine (Days 7-8) ]
    Frequent blood samples

  5. Change in plasma insulin levels after standardized test meal [ Time Frame: During standardized meals scheduled on Days 3 and 6 ]
    Frequent blood samples

  6. Change in circadian profile of plasma insulin levels [ Time Frame: During constant routine (Days 7-8) ]
    Frequent blood samples


Secondary Outcome Measures :
  1. Change in circadian phase markers, such as from core body temperature, melatonin, cortisol [ Time Frame: During constant routine (Days 7-8) ]
    Core temperature and frequent blood samples

  2. Changes circadian rhythm in resting energy expenditure [ Time Frame: During constant routine (Days 7-8) ]
    Indirect calorimetry

  3. Change in hunger and appetite, mood, and cognitive performance [ Time Frame: Tests taken throughout the protocol, Days 1-9 ]
    Subjective ratings and cognitive tests performed via computer interface

  4. Changes in microbiota, gene expression, epigenetic or proteomic markers [ Time Frame: Throughout the protocol during Days 3 and 6, and during constant routine (Days 7-8) ]
    Frequent blood samples and saliva samples

  5. Changes in sleep [ Time Frame: Sleep will be measured during the night after Days 2 and 5 ]
    Polysomnography

  6. Change in insulin sensitivity, gene expression, epigenetic, lipidomic or proteomic markers from isolated adipocytes [ Time Frame: On Day 5 of each protocol ]
    2 fat biopsies, one sample will be taken during each protocol



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298790


Contacts
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Contact: Frank AJL Scheer, PhD 617-732-7014 fscheer@rics.bwh.harvard.edu
Contact: Su Wei Heng 617-525-8655 sheng@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Su Wei Heng    617-525-8655    sheng@bwh.harvard.edu   
Contact: Nina Vujovic, PhD    617-278-0703    nvujovic@bwh.harvard.edu   
Principal Investigator: Frank AJL Scheer, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Frank AJL Scheer, PhD Brigham and Women's Hospital

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Responsible Party: Frank AJL Scheer, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02298790     History of Changes
Other Study ID Numbers: R01DK099512 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Keywords provided by Frank AJL Scheer, PhD, Brigham and Women's Hospital:
Dietary Habits
Circadian
Metabolism
Feeding Behavior
Additional relevant MeSH terms:
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Prediabetic State
Overweight
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases