Meals, Obesity, Overweight, Prediabetes
Conditions
Keywords
Dietary Habits, Circadian, Metabolism, Feeding Behavior
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.
Interventions
BEHAVIORALMeal schedule
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in circadian profile of plasma insulin 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 |
| Change in circadian profile of plasma glucose levels | During constant routine (Days 7-8) | Frequent blood samples |
| Change in plasma insulin levels after standardized test meal | During standardized meals scheduled on Days 3 and 6 | Frequent blood samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 circadian rhythm in resting energy expenditure | During constant routine (Days 7-8) | Indirect calorimetry |
| 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 |
| Changes in sleep | Sleep will be measured during the night after Days 2 and 5 | Polysomnography |
| 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 |
Countries
United States
Outcome results
None listed