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Clinical Trials/NCT02298790
NCT02298790
Completed
N/A

Effect of Dietary Habits on Metabolic Health

Brigham and Women's Hospital1 site in 1 country18 target enrollmentNovember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Overweight
Sponsor
Brigham and Women's Hospital
Enrollment
18
Locations
1
Primary Endpoint
Change in plasma insulin levels after standardized test meal
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
April 21, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Frank AJL Scheer, PhD

Frank AJL Scheer, PhD

Brigham and Women's Hospital

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

Outcomes

Primary Outcomes

Change in plasma insulin levels after standardized test meal

Time Frame: During standardized meals scheduled on Days 3 and 6

Frequent blood samples

Change in circadian profile of plasma insulin levels

Time Frame: During constant routine (Days 7-8)

Frequent blood samples

Change in circadian profile of plasma glucose levels

Time Frame: During constant routine (Days 7-8)

Frequent blood samples

Change in plasma leptin levels across sleep/wake cycle

Time Frame: During standardized meals scheduled on Days 3 and 6

Frequent blood samples

Change in circadian profile of plasma leptin

Time Frame: During constant routine (Days 7-8)

Frequent blood samples

Change in glucose tolerance

Time Frame: During standardized meals scheduled on Days 3 and 6

Frequent blood samples

Secondary Outcomes

  • Changes circadian rhythm in resting energy expenditure(During constant routine (Days 7-8))
  • Change in insulin sensitivity, gene expression, epigenetic, lipidomic or proteomic markers from isolated adipocytes(On Day 5 of each protocol)
  • Change in hunger and appetite, mood, and cognitive performance(Tests taken throughout the protocol, Days 1-9)
  • Changes in microbiota, gene expression, epigenetic or proteomic markers(Throughout the protocol during Days 3 and 6, and during constant routine (Days 7-8))
  • Change in circadian phase markers, such as from core body temperature, melatonin, cortisol(During constant routine (Days 7-8))
  • Changes in sleep(Sleep will be measured during the night after Days 2 and 5)

Study Sites (1)

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