Effect of Dietary Habits on Metabolic Health

Not Applicable

Completed

• Conditions: Meals; Overweight; Obesity; Prediabetes
• Interventions: Behavioral: Meal schedule

• Registration Number: NCT02298790
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Primary Completion: 2019-04-21
• Study Completion: 2019-04-21
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Early Meals	Meal schedule	Meals are eaten early in the wake episode
Late Meals	Meal schedule	Meals are eaten late in the wake episode

Primary Outcome Measures

Name	Time	Method
Change in plasma insulin levels after standardized test meal	During standardized meals scheduled on Days 3 and 6	Frequent blood samples
Change in circadian profile of plasma insulin levels	During constant routine (Days 7-8)	Frequent blood samples
Change in circadian profile of plasma glucose levels	During constant routine (Days 7-8)	Frequent blood samples
Change in plasma leptin levels across sleep/wake cycle	During standardized meals scheduled on Days 3 and 6	Frequent blood samples
Change in circadian profile of plasma leptin	During constant routine (Days 7-8)	Frequent blood samples
Change in glucose tolerance	During standardized meals scheduled on Days 3 and 6	Frequent blood samples

Secondary Outcome Measures

Name	Time	Method
Changes circadian rhythm in resting energy expenditure	During constant routine (Days 7-8)	Indirect calorimetry
Change in insulin sensitivity, gene expression, epigenetic, lipidomic or proteomic markers from isolated adipocytes	On Day 5 of each protocol	2 fat biopsies, one sample will be taken during each protocol
Change in hunger and appetite, mood, and cognitive performance	Tests taken throughout the protocol, Days 1-9	Subjective ratings and cognitive tests performed via computer interface
Changes in microbiota, gene expression, epigenetic or proteomic markers	Throughout the protocol during Days 3 and 6, and during constant routine (Days 7-8)	Frequent blood samples and saliva samples
Change in circadian phase markers, such as from core body temperature, melatonin, cortisol	During constant routine (Days 7-8)	Core temperature and frequent blood samples
Changes in sleep	Sleep will be measured during the night after Days 2 and 5	Polysomnography

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States