Effect of Dietary Habits on Metabolic Health

Mass General Brigham

Status: Completed

Conditions: Prediabetes; Overweight; Obesity; Meals

Treatments: Behavioral: Meal schedule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02298790

R01DK099512

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Early Meals

Experimental group

Description:

Meals are eaten early in the wake episode

Treatment:

Behavioral: Meal schedule

Late Meals

Experimental group

Description:

Meals are eaten late in the wake episode

Treatment:

Behavioral: Meal schedule