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OpenTrials
Completed

NCT Number: NCT02298790

Effect of Dietary Habits on Metabolic Health

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal schedule

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Nov 24, 2014
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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